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Consolidation Therapy With Hu3S193 for Women With Ovarian, Primary Peritoneal or Fallopian Tube Cancer

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ClinicalTrials.gov Identifier: NCT01137071
Recruitment Status : Terminated (Total number of pts expected to be enrolled would not be met.)
First Posted : June 4, 2010
Results First Posted : December 29, 2016
Last Update Posted : February 23, 2017
Sponsor:
Information provided by (Responsible Party):
Recepta Biopharma

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Fallopian Tube Cancer
Ovarian Cancer
Peritoneal Cavity Cancer
Intervention Biological: Monoclonal antibody Hu3S193
Enrollment 29
Recruitment Details This was a Brazilian, multicentric clinical trial. From April 12, 2011 to October 31, 2013 a total of 37 patients were screened for this study, of whom 29 received at least one dose of the investigational product and 07 were considered noneligible.
Pre-assignment Details Patients were considered included in the study on the day of the first investigational product administration after investigator assured that patients met all the inclusion criterions and none of the exclusion criterions.
Arm/Group Title hu3S193
Hide Arm/Group Description hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
Period Title: Overall Study
Started 29 [1]
Completed 15 [2]
Not Completed 14
Reason Not Completed
Disease Progression             11
Withdrawal by Subject             2
Wrongly Included             1
[1]
all patients considered eligible were included on the study
[2]
Of the eligible patients
Arm/Group Title Monoclonal Antibody hu3S193
Hide Arm/Group Description hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
Overall Number of Baseline Participants 29
Hide Baseline Analysis Population Description
A total of 37 patients were screened for this study of whom 29 were considered eligible and included in the study (baseline participants).
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 29 participants
55.69
(29 to 67)
Gender   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 29 participants
Female
29
 100.0%
Male
0
   0.0%
[1]
Measure Description: # of Female patients is due to the inclusion criteria number #02: "Female patients of ≥18 years of age"
Race/Ethnicity, Customized   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 29 participants
White 24
Black 1
Yellow 0
Brown 4
Other 0
[1]
Measure Description: Race/Ethnicity/Color was recorded at screening
Region of Enrollment   [1] 
Measure Type: Number
Unit of measure:  Participants
Brazil Number Analyzed 29 participants
29
[1]
Measure Description: The clinical trial was performed only in Brazil
1.Primary Outcome
Title 1-year PFS2 Rate After the Beginning of Rescue Platinum-based Chemotherapy
Hide Description

PFS2 is defined by the interval from the beginning of rescue platinum-based chemotherapy until documented disease progression or death for any cause while the patient was under study or during the prolonged follow-up period.

Disease progression is defined by appearance of any new lesion (measurable and non-measurable) by the RECIST criteria. Disease progression date is the date when a new lesion is documented.

Time Frame 1-Year - From platinum-based rescue chemotherapy start date until documented disease progression or death of any cause whichever occurred first.
Hide Outcome Measure Data
Hide Analysis Population Description
In the ITT (intention to treat) population, 25 patients out of the 29 considered for the PFS2 analysis presented disease progression or death and 4 were censored. The median time to disease progression or death was 11.8 months (95% CI (confidence interval), 10.6 to 13.9 months).
Arm/Group Title hu3S193
Hide Arm/Group Description:
hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
Overall Number of Participants Analyzed 29
Median (95% Confidence Interval)
Unit of Measure: Months
11.7614
(10.5902 to 13.9251)
2.Secondary Outcome
Title 1-year Disease Progression-free Survival Rate
Hide Description [Not Specified]
Time Frame 1 year from the beginning of platinum-based rescue chemotherapy start date
Hide Outcome Measure Data
Hide Analysis Population Description
In the ITT (Intention-to-treat) population, 25 patients out of the 29 considered for the PFS2 analysis presented disease progression or death and 4 were censored.
Arm/Group Title hu3S193
Hide Arm/Group Description:
hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
Overall Number of Participants Analyzed 29
Measure Type: Number
Unit of Measure: percentage of participants
48.2
3.Secondary Outcome
Title Two-year Overall Survival Rate
Hide Description Overall survival was calculated as the time interval between the date of beginning of rescue platinum-based chemotherapy and date of death for any cause.
Time Frame 2-year overall survival rate after the beginning of rescue platinum-based chemotherapy.
Hide Outcome Measure Data
Hide Analysis Population Description
Within the ITT population, 7 patients died and 22 were censored. The 2-year overall survival rate was 70.7%.
Arm/Group Title hu3S193
Hide Arm/Group Description:
hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
Overall Number of Participants Analyzed 29
Measure Type: Number
Unit of Measure: percentage of participants
70.7
4.Secondary Outcome
Title Safety - Vital Signs - Heart Rate
Hide Description Vital signs were assessed throughout the study treatment (consolidation therapy).Through study completion, an average of 27 weeks.
Time Frame Baseline, week 2 , week 4 and week 27
Hide Outcome Measure Data
Hide Analysis Population Description
All patients enrolled in this study received at least one dose of Hu3S193 (30 mg/m2) – ITT dataset. Baseline n=29, week 2 n=27, week 4 n= 28, week 27 n= 14
Arm/Group Title hu3S193
Hide Arm/Group Description:
hu3S193 was administered to 29 patients at the dose of 30mg/m2 every other week (total of 12 infusions) for a total of 23 weeks.
Overall Number of Participants Analyzed 29
Median (Standard Deviation)
Unit of Measure: bpm
Baseline 78.00  (12.11)
Week 2 80.00  (11.49)
Week 4 76.00  (10.58)
Week 27 75.00  (9.84)
5.Secondary Outcome
Title Safety - Vital Signs - Respiratory Rate
Hide Description Vital signs during the study treatment (consolidation therapy). Through study completion, an average of 27 weeks.
Time Frame Baseline, week 2, week 4 and week 27
Hide Outcome Measure Data
Hide Analysis Population Description
All patients enrolled in this study received at least one dose of Hu3S193 (30 mg/m2) – ITT dataset. Baseline n=29, week 2 n=27, week 4 n= 28, week 27 n= 14
Arm/Group Title hu3S193
Hide Arm/Group Description:
hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
Overall Number of Participants Analyzed 29
Median (Standard Deviation)
Unit of Measure: ipm (Incursions per minute)
Baseline 19.00  (2.10)
Week 2 19.00  (1.62)
Week 4 19.00  (1.59)
Week 27 19.00  (1.86)
6.Secondary Outcome
Title Safety - Vital Signs - Systolic and Diastolic Blood Pressure
Hide Description Both parameters were assessed throughout the study treatment. Vital signs during the study treatment (consolidation therapy). Through study completion, an average of 27 weeks.
Time Frame Baseline, week 2, week 4 and week 27
Hide Outcome Measure Data
Hide Analysis Population Description
All patients enrolled in this study received at least one dose of Hu3S193 (30 mg/m2) - ITT dataset. Diastolic Baseline n=29, week 2 n=27, week 4 n= 28, week 27 n= 14/ Systolic Baseline n=28, week 2 n=27, week 4 n= 28, week 27 n= 14
Arm/Group Title hu3S193
Hide Arm/Group Description:
hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
Overall Number of Participants Analyzed 29
Median (Standard Deviation)
Unit of Measure: mmHg
Diastolic Baseline 80.00  (8.88)
Diastolic Week 2 77.00  (9.04)
Diastolic Week 4 70.00  (7.92)
Diastolic Week 27 80.00  (8.63)
Systolic Baseline 115.00  (15.93)
Systolic Week 2 110.00  (14.79)
Systolic Week 4 118.00  (11.32)
Systolic Week 27 120.00  (13.00)
7.Secondary Outcome
Title Safety - Vital Signs - Temperature
Hide Description Vital signs during the study treatment (consolidation therapy). Through study completion, an average of 27 weeks.
Time Frame Baseline, week 2, week 4 and week 27
Hide Outcome Measure Data
Hide Analysis Population Description
All patients enrolled in this study received at least one dose of Hu3S193 (30 mg/m2) - ITT dataset. Baseline n=29, week 2 n=27, week 4 n= 28, week 27 n= 14
Arm/Group Title hu3S193
Hide Arm/Group Description:
hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
Overall Number of Participants Analyzed 29
Median (Standard Deviation)
Unit of Measure: °C
Baseline 36.00  (0.41)
Week 2 36.00  (0.50)
Week 4 35.90  (0.43)
Week 27 35.70  (0.51)
8.Secondary Outcome
Title Incidence of Adverse Events (AEs) - Gastrointestinal Disorders
Hide Description The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.
Time Frame From the first infusion of medication to 30 days after the last one
Hide Outcome Measure Data
Hide Analysis Population Description
All patients who received at least one dose of investigational product were included in the safety dataset.
Arm/Group Title hu3S193
Hide Arm/Group Description:
hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
Overall Number of Participants Analyzed 29
Measure Type: Number
Unit of Measure: Incidence
Nausea 19
Vomiting 17
Abdominal pain 9
Constipation 7
Diarrhoea 6
Abdominal pain upper 3
Dry Mouth 2
Dyspepsia 2
Abdominal pain lower 1
Intestinal Obstruction 1
9.Secondary Outcome
Title Incidence of Adverse Events (AEs) - General Disorders and Administration Site Conditions
Hide Description The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.
Time Frame From the first infusion of medication to 30 days after the last one
Hide Outcome Measure Data
Hide Analysis Population Description
All patients who received at least one dose of investigational product were included in the safety dataset.
Arm/Group Title hu3S193
Hide Arm/Group Description:
hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
Overall Number of Participants Analyzed 29
Measure Type: Number
Unit of Measure: Incidence
Influenza like illness 8
Fatigue 3
Pain 2
Pyrexia 1
10.Secondary Outcome
Title Incidence of Adverse Events (AEs) - Musculoskeletal and Connective Tissue Disorders
Hide Description The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.
Time Frame From the first infusion of medication to 30 days after the last one
Hide Outcome Measure Data
Hide Analysis Population Description
All patients who received at least one dose of investigational product were included in the safety dataset.
Arm/Group Title hu3S193
Hide Arm/Group Description:
hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
Overall Number of Participants Analyzed 29
Measure Type: Number
Unit of Measure: Incidence
Myalgia 4
Back pain 3
Pain in extremity 2
Arthralgia 1
Groin pain 1
Knee pain 1
Muscle tightness 1
Musculoskeletal pain 10
11.Secondary Outcome
Title Incidence of Adverse Events (AEs) - Immune System Disorders
Hide Description The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.
Time Frame From the first infusion of medication to 30 days after the last one
Hide Outcome Measure Data
Hide Analysis Population Description
All patients who received at least one dose of investigational product were included in the safety dataset.
Arm/Group Title hu3S193
Hide Arm/Group Description:
hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
Overall Number of Participants Analyzed 29
Measure Type: Number
Unit of Measure: Incidence
Hypersensitivity 9
Drug Hypersensitivity 2
12.Secondary Outcome
Title Incidence of Adverse Events (AEs) - Nervous System Disorders
Hide Description The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.
Time Frame From the first infusion of medication to 30 days after the last one
Hide Outcome Measure Data
Hide Analysis Population Description
All patients who received at least one dose of investigational product were included in the safety dataset.
Arm/Group Title hu3S193
Hide Arm/Group Description:
hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks.
Overall Number of Participants Analyzed 29
Measure Type: Number
Unit of Measure: Incidence
Headache 9
Paraesthesia 1
Peripheral sensory neuropathy 1
Tremor 1
13.Secondary Outcome
Title Incidence of Adverse Events (AEs) - Investigations
Hide Description The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.
Time Frame From the first infusion of medication to 30 days after the last one
Hide Outcome Measure Data
Hide Analysis Population Description
All patients who received at least one dose of investigational product were included in the safety dataset.
Arm/Group Title hu3S193
Hide Arm/Group Description:
hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
Overall Number of Participants Analyzed 29
Measure Type: Number
Unit of Measure: Incidence
Neutrophil count decreased 5
White blood cell count decreased 3
14.Secondary Outcome
Title Incidence of Adverse Events (AEs) - Respiratory, Thoracic and Mediastinal Disorders
Hide Description The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.
Time Frame From the first infusion of medication to 30 days after the last one
Hide Outcome Measure Data
Hide Analysis Population Description
All patients who received at least one dose of investigational product were included in the safety dataset.
Arm/Group Title hu3S193
Hide Arm/Group Description:
hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
Overall Number of Participants Analyzed 29
Measure Type: Number
Unit of Measure: Incidence
Cough 6
Productive Cough 1
15.Secondary Outcome
Title Incidence of Adverse Events (AEs) - Infections and Infestations; Gastrointestinal Disorders
Hide Description The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.
Time Frame From the first infusion of medication to 30 days after the last one
Hide Outcome Measure Data
Hide Analysis Population Description
All patients who received at least one dose of investigational product were included in the safety dataset.
Arm/Group Title hu3S193
Hide Arm/Group Description:
hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
Overall Number of Participants Analyzed 29
Measure Type: Number
Unit of Measure: Incidence
Oral Herpes 2
Clostridium difficile colitis 1
Gastroenteritis 1
Tooth abscess 1
16.Secondary Outcome
Title Incidence of Adverse Events (AEs) - Blood and Lymphatic System Disorders (Anaemia)
Hide Description The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.
Time Frame From the first infusion of medication to 30 days after the last one
Hide Outcome Measure Data
Hide Analysis Population Description
All patients who received at least one dose of investigational product were included in the safety dataset.
Arm/Group Title hu3S193
Hide Arm/Group Description:
hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
Overall Number of Participants Analyzed 29
Measure Type: Number
Unit of Measure: Incidence
4
17.Secondary Outcome
Title Incidence of Adverse Events (AEs) - Infections and Infestations; Respiratory, Thoracic and Mediastinal Disorders
Hide Description The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.
Time Frame From the first infusion of medication to 30 days after the last one
Hide Outcome Measure Data
Hide Analysis Population Description
All patients who received at least one dose of investigational product were included in the safety dataset.
Arm/Group Title hu3S193
Hide Arm/Group Description:
hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
Overall Number of Participants Analyzed 29
Measure Type: Number
Unit of Measure: Incidence
Sinusitis 2
Respiratory tract infection 1
Tonsillitis 1
18.Secondary Outcome
Title Incidence of Adverse Events (AEs) - Psychiatric Disorders (Anxiety)
Hide Description The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.
Time Frame From the first infusion of medication to 30 days after the last one
Hide Outcome Measure Data
Hide Analysis Population Description
All patients who received at least one dose of investigational product were included in the safety dataset.
Arm/Group Title hu3S193
Hide Arm/Group Description:

Monoclonal antibody hu3S193 was administered to 29 patients at the dose of 30mg/m2 every other week (total of 12 infusions) for a total of 23 weeks.

Anti-Lewis Y humanized monoclonal antibody designated "orphan drug" by the FDA on March 09, 2012 for the treatment of ovarian cancer, not yet approved for the orphan designation.

Overall Number of Participants Analyzed 29
Measure Type: Number
Unit of Measure: Incidence
4
19.Secondary Outcome
Title Incidence of Adverse Events (AEs) - Vascular Disorders
Hide Description The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.
Time Frame From the first infusion of medication to 30 days after the last one
Hide Outcome Measure Data
Hide Analysis Population Description
All patients who received at least one dose of investigational product were included in the safety dataset.
Arm/Group Title hu3S193
Hide Arm/Group Description:
hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
Overall Number of Participants Analyzed 29
Measure Type: Number
Unit of Measure: Incidence
Hypertension 2
Hyperaemia 1
Hypotension 1
20.Secondary Outcome
Title Incidence of Adverse Events (AEs) - Cardiac Disorders; General Disorders and Administration Site Conditions; Respiratory, Thoracic and Mediastinal Disorders (Chest Pain)
Hide Description The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.
Time Frame From the first infusion of medication to 30 days after the last one
Hide Outcome Measure Data
Hide Analysis Population Description
All patients who received at least one dose of investigational product were included in the safety dataset.
Arm/Group Title hu3S193
Hide Arm/Group Description:
hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
Overall Number of Participants Analyzed 29
Measure Type: Number
Unit of Measure: Incidence
3
21.Secondary Outcome
Title Incidence of Adverse Events (AEs) - General Disorders and Administration Site Conditions; Musculoskeletal and Connective Tissue Disorders (Chills)
Hide Description The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.
Time Frame From the first infusion of medication to 30 days after the last one
Hide Outcome Measure Data
Hide Analysis Population Description
All patients who received at least one dose of investigational product were included in the safety dataset.
Arm/Group Title hu3S193
Hide Arm/Group Description:

Monoclonal antibody hu3S193 was administered to 29 patients at the dose of 30mg/m2 every other week (total of 12 infusions) for a total of 23 weeks.

Anti-Lewis Y humanized monoclonal antibody designated "orphan drug" by the FDA on March 09, 2012 for the treatment of ovarian cancer, not yet approved for the orphan designation.

Overall Number of Participants Analyzed 29
Measure Type: Number
Unit of Measure: Incidence
3
22.Secondary Outcome
Title Incidence of Adverse Events (AEs) - Skin and Subcutaneous Tissue Disorders
Hide Description The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.
Time Frame From the first infusion of medication to 30 days after the last one
Hide Outcome Measure Data
Hide Analysis Population Description
All patients who received at least one dose of investigational product were included in the safety dataset.
Arm/Group Title hu3S193
Hide Arm/Group Description:
hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
Overall Number of Participants Analyzed 29
Measure Type: Number
Unit of Measure: Incidence
Erythema 2
Pruritus 2
23.Secondary Outcome
Title Incidence of Adverse Events (AEs) - Ear and Labyrinth Disorders
Hide Description The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.
Time Frame From the first infusion of medication to 30 days after the last one
Hide Outcome Measure Data
Hide Analysis Population Description
All patients who received at least one dose of investigational product were included in the safety dataset.
Arm/Group Title hu3S193
Hide Arm/Group Description:
hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
Overall Number of Participants Analyzed 29
Measure Type: Number
Unit of Measure: Incidence
Cerumen impaction 1
Ear pain 1
24.Secondary Outcome
Title Incidence of Adverse Events (AEs) - Hepatobiliary Disorders; Injury, Poisoning and Procedural Complications (Hepatotoxicity)
Hide Description The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.
Time Frame From the first infusion of medication to 30 days after the last one
Hide Outcome Measure Data
Hide Analysis Population Description
All patients who received at least one dose of investigational product were included in the safety dataset.
Arm/Group Title hu3S193
Hide Arm/Group Description:
hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
Overall Number of Participants Analyzed 29
Measure Type: Number
Unit of Measure: Incidence
2
25.Secondary Outcome
Title Incidence of Adverse Events (AEs) - Immune System Disorders; General Disorders and Administration Site Conditions; Injury, Poisoning and Procedural Complications (Infusion Related Reaction)
Hide Description The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.
Time Frame From the first infusion of medication to 30 days after the last one
Hide Outcome Measure Data
Hide Analysis Population Description
All patients who received at least one dose of investigational product were included in the safety dataset.
Arm/Group Title hu3S193
Hide Arm/Group Description:
hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
Overall Number of Participants Analyzed 29
Measure Type: Number
Unit of Measure: Incidence
2
26.Secondary Outcome
Title Incidence of Adverse Events (AEs) - Immune System Disorders; Respiratory, Thoracic and Mediastinal Disorders
Hide Description The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.
Time Frame From the first infusion of medication to 30 days after the last one
Hide Outcome Measure Data
Hide Analysis Population Description
All patients who received at least one dose of investigational product were included in the safety dataset.
Arm/Group Title hu3S193
Hide Arm/Group Description:
hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
Overall Number of Participants Analyzed 29
Measure Type: Number
Unit of Measure: Incidence
Bronchospasm 1
Rhinitis allergic 1
27.Secondary Outcome
Title Incidence of Adverse Events (AEs) - Musculoskeletal and Connective Tissue Disorders; General Disorders and Administration Site Conditions; Nervous System Disorders (Spinal Pain)
Hide Description The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.
Time Frame From the first infusion of medication to 30 days after the last one
Hide Outcome Measure Data
Hide Analysis Population Description
All patients who received at least one dose of investigational product were included in the safety dataset.
Arm/Group Title hu3S193
Hide Arm/Group Description:
hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
Overall Number of Participants Analyzed 29
Measure Type: Number
Unit of Measure: Incidence
2
28.Secondary Outcome
Title Incidence of Adverse Events (AEs) - Musculoskeletal and Connective Tissue Disorders; Injury, Poisoning and Procedural Complications
Hide Description The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.
Time Frame From the first infusion of medication to 30 days after the last one
Hide Outcome Measure Data
Hide Analysis Population Description
All patients who received at least one dose of investigational product were included in the safety dataset.
Arm/Group Title hu3S193
Hide Arm/Group Description:
hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
Overall Number of Participants Analyzed 29
Measure Type: Number
Unit of Measure: Incidence
Hip fracture 1
Upper limb fracture 1
29.Secondary Outcome
Title Incidence of Adverse Events (AEs) - Psychiatric Disorders (Depression)
Hide Description The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.
Time Frame From the first infusion of medication to 30 days after the last one
Hide Outcome Measure Data
Hide Analysis Population Description
All patients who received at least one dose of investigational product were included in the safety dataset.
Arm/Group Title hu3S193
Hide Arm/Group Description:
hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
Overall Number of Participants Analyzed 29
Measure Type: Number
Unit of Measure: Incidence
2
30.Secondary Outcome
Title Incidence of Adverse Events (AEs) - Renal and Urinary Disorders (Dysuria)
Hide Description The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.
Time Frame From the first infusion of medication to 30 days after the last one
Hide Outcome Measure Data
Hide Analysis Population Description
All patients who received at least one dose of investigational product were included in the safety dataset.
Arm/Group Title hu3S193
Hide Arm/Group Description:
hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
Overall Number of Participants Analyzed 29
Measure Type: Number
Unit of Measure: Incidence
2
31.Secondary Outcome
Title Incidence of Adverse Events (AEs) - Renal and Urinary Disorders; Infections and Infestations (Urinary Tract Infection)
Hide Description The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.
Time Frame From the first infusion of medication to 30 days after the last one
Hide Outcome Measure Data
Hide Analysis Population Description
All patients who received at least one dose of investigational product were included in the safety dataset.
Arm/Group Title hu3S193
Hide Arm/Group Description:
hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
Overall Number of Participants Analyzed 29
Measure Type: Number
Unit of Measure: Incidence
2
32.Secondary Outcome
Title Incidence of Adverse Events (AEs) - Reproductive System and Breast Disorders (Vulvovaginal Dryness)
Hide Description The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.
Time Frame From the first infusion of medication to 30 days after the last one
Hide Outcome Measure Data
Hide Analysis Population Description
All patients who received at least one dose of investigational product were included in the safety dataset.
Arm/Group Title hu3S193
Hide Arm/Group Description:
hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
Overall Number of Participants Analyzed 29
Measure Type: Number
Unit of Measure: Incidence
2
33.Secondary Outcome
Title Incidence of Adverse Events (AEs) - Respiratory, Thoracic and Mediastinal Disorders; Cardiac Disorders (Dyspnoea)
Hide Description The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.
Time Frame From the first infusion of medication to 30 days after the last one
Hide Outcome Measure Data
Hide Analysis Population Description
All patients who received at least one dose of investigational product were included in the safety dataset.
Arm/Group Title hu3S193
Hide Arm/Group Description:
hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
Overall Number of Participants Analyzed 29
Measure Type: Number
Unit of Measure: Incidence
2
34.Secondary Outcome
Title Incidence of Adverse Events (AEs) - Skin and Subcutaneous Tissue Disorders; Injury, Poisoning and Procedural Complications
Hide Description The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.
Time Frame From the first infusion of medication to 30 days after the last one
Hide Outcome Measure Data
Hide Analysis Population Description
All patients who received at least one dose of investigational product were included in the safety dataset.
Arm/Group Title hu3S193
Hide Arm/Group Description:
hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
Overall Number of Participants Analyzed 29
Measure Type: Number
Unit of Measure: Incidence
Excoriation 1
Injection site erythema 1
35.Secondary Outcome
Title Incidence of Adverse Events (AEs) - Cardiac Disorders; Vascular Disorders; Nervous System Disorders (Dizziness)
Hide Description The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.
Time Frame From the first infusion of medication to 30 days after the last one
Hide Outcome Measure Data
Hide Analysis Population Description
All patients who received at least one dose of investigational product were included in the safety dataset.
Arm/Group Title hu3S193
Hide Arm/Group Description:
hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
Overall Number of Participants Analyzed 29
Measure Type: Number
Unit of Measure: Incidence
1
36.Secondary Outcome
Title Incidence of Adverse Events (AEs) - Ear and Labyrinth Disorders; Nervous System Disorders (Vertigo)
Hide Description The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.
Time Frame From the first infusion of medication to 30 days after the last one
Hide Outcome Measure Data
Hide Analysis Population Description
All patients who received at least one dose of investigational product were included in the safety dataset.
Arm/Group Title hu3S193
Hide Arm/Group Description:
hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
Overall Number of Participants Analyzed 29
Measure Type: Number
Unit of Measure: Incidence
1
37.Secondary Outcome
Title Incidence of Adverse Events (AEs) - Endocrine Disorders; Metabolism and Nutrition Disorders (Hyperglycaemia)
Hide Description The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.
Time Frame From the first infusion of medication to 30 days after the last one
Hide Outcome Measure Data
Hide Analysis Population Description
All patients who received at least one dose of investigational product were included in the safety dataset.
Arm/Group Title hu3S193
Hide Arm/Group Description:
hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
Overall Number of Participants Analyzed 29
Measure Type: Number
Unit of Measure: Incidence
1
38.Secondary Outcome
Title Incidence of Adverse Events (AEs) - Eye Disorders (Ocular Hyperaemia)
Hide Description The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.
Time Frame From the first infusion of medication to 30 days after the last one
Hide Outcome Measure Data
Hide Analysis Population Description
All patients who received at least one dose of investigational product were included in the safety dataset.
Arm/Group Title hu3S193
Hide Arm/Group Description:
hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
Overall Number of Participants Analyzed 29
Measure Type: Number
Unit of Measure: Incidence
1
39.Secondary Outcome
Title Incidence of Adverse Events (AEs) - Gastrointestinal Disorders; Infections and Infestations; Respiratory, Thoracic and Mediastinal Disorders (Pharyngitis)
Hide Description The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.
Time Frame From the first infusion of medication to 30 days after the last one
Hide Outcome Measure Data
Hide Analysis Population Description
All patients who received at least one dose of investigational product were included in the safety dataset.
Arm/Group Title hu3S193
Hide Arm/Group Description:
hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
Overall Number of Participants Analyzed 29
Measure Type: Number
Unit of Measure: Incidence
1
40.Secondary Outcome
Title Incidence of Adverse Events (AEs) - Gastrointestinal Disorders; Reproductive System and Breast Disorders; Renal and Urinary Disorders (Pelvic Pain)
Hide Description The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.
Time Frame From the first infusion of medication to 30 days after the last one
Hide Outcome Measure Data
Hide Analysis Population Description
All patients who received at least one dose of investigational product were included in the safety dataset.
Arm/Group Title hu3S193
Hide Arm/Group Description:
hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
Overall Number of Participants Analyzed 29
Measure Type: Number
Unit of Measure: Incidence
1
41.Secondary Outcome
Title Incidence of Adverse Events (AEs) - Gastrointestinal Disorders; Vascular Disorders (Anal Haemorrhage)
Hide Description The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.
Time Frame From the first infusion of medication to 30 days after the last one
Hide Outcome Measure Data
Hide Analysis Population Description
All patients who received at least one dose of investigational product were included in the safety dataset.
Arm/Group Title hu3S193
Hide Arm/Group Description:
hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
Overall Number of Participants Analyzed 29
Measure Type: Number
Unit of Measure: Incidence
1
42.Secondary Outcome
Title Incidence of Adverse Events (AEs) - General Disorders and Administration Site Conditions; Injury, Poisoning and Procedural Complications (Hyperthermia)
Hide Description The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.
Time Frame From the first infusion of medication to 30 days after the last one
Hide Outcome Measure Data
Hide Analysis Population Description
All patients who received at least one dose of investigational product were included in the safety dataset.
Arm/Group Title hu3S193
Hide Arm/Group Description:
hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
Overall Number of Participants Analyzed 29
Measure Type: Number
Unit of Measure: Incidence
1
43.Secondary Outcome
Title Incidence of Adverse Events (AEs) - General Disorders and Administration Site Conditions; Injury, Poisoning and Procedural Complications (Catheter Site Inflammation)
Hide Description The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.
Time Frame From the first infusion of medication to 30 days after the last one
Hide Outcome Measure Data
Hide Analysis Population Description
All patients who received at least one dose of investigational product were included in the safety dataset.
Arm/Group Title hu3S193
Hide Arm/Group Description:
hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
Overall Number of Participants Analyzed 29
Measure Type: Number
Unit of Measure: Incidence
1
44.Secondary Outcome
Title Incidence of Adverse Events (AEs) - Immune System Disorders; Blood and Lymphatic System Disorders; Injury, Poisoning and Procedural Complications (Transfusion Reaction)
Hide Description The incidence of adverse events (percentage of patients with at least one adverse event and serious adverse events (overall and with reasonable relationship)) was assessed for the safety population
Time Frame From the first infusion of medication to 30 days after the last one
Hide Outcome Measure Data
Hide Analysis Population Description
All patients who received at least one dose of investigational product were included in the safety dataset.
Arm/Group Title hu3S193
Hide Arm/Group Description:
hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
Overall Number of Participants Analyzed 29
Measure Type: Number
Unit of Measure: Incidence
1
45.Secondary Outcome
Title Incidence of Adverse Events (AEs) - Infections and Infestations; Respiratory, Thoracic and Mediastinal Disorders (Bronchitis)
Hide Description The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.
Time Frame From the first infusion of medication to 30 days after the last one
Hide Outcome Measure Data
Hide Analysis Population Description
All patients who received at least one dose of investigational product were included in the safety dataset.
Arm/Group Title hu3S193
Hide Arm/Group Description:
hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
Overall Number of Participants Analyzed 29
Measure Type: Number
Unit of Measure: Incidence
1
46.Secondary Outcome
Title Incidence of Adverse Events (AEs) - Infections and Infestations; Renal and Urinary Disorders (Urinary Tract Infection Bacterial)
Hide Description The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.
Time Frame From the first infusion of medication to 30 days after the last one
Hide Outcome Measure Data
Hide Analysis Population Description
All patients who received at least one dose of investigational product were included in the safety dataset.
Arm/Group Title hu3S193
Hide Arm/Group Description:
hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
Overall Number of Participants Analyzed 29
Measure Type: Number
Unit of Measure: Incidence
1
47.Secondary Outcome
Title Incidence of Adverse Events (AEs) - Investigations (Blood Cholesterol Increased)
Hide Description The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.
Time Frame From the first infusion of medication to 30 days after the last one
Hide Outcome Measure Data
Hide Analysis Population Description
All patients who received at least one dose of investigational product were included in the safety dataset.
Arm/Group Title hu3S193
Hide Arm/Group Description:
hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
Overall Number of Participants Analyzed 29
Measure Type: Number
Unit of Measure: Incidence
1
48.Secondary Outcome
Title Incidence of Adverse Events (AEs) - Musculoskeletal and Connective Tissue Disorders; General Disorders and Administration Site Conditions; Renal and Urinary Disorders (Flank Pain)
Hide Description The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.
Time Frame From the first infusion of medication to 30 days after the last one
Hide Outcome Measure Data
Hide Analysis Population Description
All patients who received at least one dose of investigational product were included in the safety dataset.
Arm/Group Title hu3S193
Hide Arm/Group Description:
hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
Overall Number of Participants Analyzed 29
Measure Type: Number
Unit of Measure: Incidence
1
49.Secondary Outcome
Title Incidence of Adverse Events (AEs) - Nervous System Disorders; Psychiatric Disorders; Respiratory, Thoracic and Mediastinal Disorders (Hoarseness)
Hide Description The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.
Time Frame From the first infusion of medication to 30 days after the last one
Hide Outcome Measure Data
Hide Analysis Population Description
All patients who received at least one dose of investigational product were included in the safety dataset.
Arm/Group Title hu3S193
Hide Arm/Group Description:
hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
Overall Number of Participants Analyzed 29
Measure Type: Number
Unit of Measure: Incidence
1
50.Secondary Outcome
Title Incidence of Adverse Events (AEs) - Psychiatric Disorders; Nervous System Disorders (Insomnia)
Hide Description The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.
Time Frame From the first infusion of medication to 30 days after the last one
Hide Outcome Measure Data
Hide Analysis Population Description
All patients who received at least one dose of investigational product were included in the safety dataset.
Arm/Group Title hu3S193
Hide Arm/Group Description:
hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
Overall Number of Participants Analyzed 29
Measure Type: Number
Unit of Measure: Incidence
1
51.Secondary Outcome
Title Incidence of Adverse Events (AEs) - Skin and Subcutaneous Tissue Disorders; Infections and Infestations (Tinea Pedis)
Hide Description The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.
Time Frame From the first infusion of medication to 30 days after the last one
Hide Outcome Measure Data
Hide Analysis Population Description
All patients who received at least one dose of investigational product were included in the safety dataset.
Arm/Group Title hu3S193
Hide Arm/Group Description:
hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
Overall Number of Participants Analyzed 29
Measure Type: Number
Unit of Measure: Incidence
1
52.Secondary Outcome
Title Incidence of Adverse Events (AEs) - Skin and Subcutaneous Tissue Disorders; Reproductive System and Breast Disorders (Vulvovaginal Pruritus)
Hide Description The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.
Time Frame From the first infusion of medication to 30 days after the last one
Hide Outcome Measure Data
Hide Analysis Population Description
All patients who received at least one dose of investigational product were included in the safety dataset.
Arm/Group Title hu3S193
Hide Arm/Group Description:
hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
Overall Number of Participants Analyzed 29
Measure Type: Number
Unit of Measure: Incidence
1
53.Secondary Outcome
Title Incidence of Adverse Events (AEs) - Vascular Disorders; Gastrointestinal Disorders (Haemorrhoids)
Hide Description The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.
Time Frame From the first infusion of medication to 30 days after the last one
Hide Outcome Measure Data
Hide Analysis Population Description
All patients who received at least one dose of investigational product were included in the safety dataset.
Arm/Group Title hu3S193
Hide Arm/Group Description:
hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
Overall Number of Participants Analyzed 29
Measure Type: Number
Unit of Measure: Incidence
1
54.Secondary Outcome
Title Incidence of Adverse Events (AEs) - Vascular Disorders; Respiratory, Thoracic and Mediastinal Disorders (Epistaxis)
Hide Description The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.
Time Frame From the first infusion of medication to 30 days after the last one
Hide Outcome Measure Data
Hide Analysis Population Description
All patients who received at least one dose of investigational product were included in the safety dataset.
Arm/Group Title hu3S193
Hide Arm/Group Description:
hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
Overall Number of Participants Analyzed 29
Measure Type: Number
Unit of Measure: Incidence
1
55.Secondary Outcome
Title Incidence of Serious Adverse Events (SAEs) - Gastrointestinal Disorders
Hide Description A SAE was defined as an AE that met one of the following conditions: Death during the protocol-defined surveillance period; Potentially fatal event (defined as a patient at immediate risk of death at the time of the event); An event requiring the patient’s hospitalization or prolongation of an existing hospitalization during the protocol-defined surveillance period; An event resulting in congenital anomaly or birth defect; An event resulting in a persistent or significant disability/incapacity; Any other major medical event that did not result in death, was not life threatening, or did not require hospitalization, but that could be considered a SAE when, based on the appropriate medical judgment, it presented a risk for the patient and required medical or surgical intervention to prevent one of the outcomes listed above.
Time Frame From the first infusion of medication to 30 days after the last one
Hide Outcome Measure Data
Hide Analysis Population Description
All patients who received at least one dose of investigational product were included in the safety dataset.
Arm/Group Title Monoclonal Antibody hu3S193
Hide Arm/Group Description:
hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
Overall Number of Participants Analyzed 29
Measure Type: Number
Unit of Measure: Incidence
Intestinal obstruction 1
Vomiting 1
56.Secondary Outcome
Title Incidence of Serious Adverse Events (SAEs) - Musculoskeletal and Connective Tissue Disorders - Hip Fracture
Hide Description A SAE was defined as an AE that met one of the following conditions: Death during the protocol-defined surveillance period; Potentially fatal event (defined as a patient at immediate risk of death at the time of the event); An event requiring the patient's hospitalization or prolongation of an existing hospitalization during the protocol-defined surveillance period; An event resulting in congenital anomaly or birth defect; An event resulting in a persistent or significant disability/incapacity; Any other major medical event that did not result in death, was not life threatening, or did not require hospitalization, but that could be considered a SAE when, based on the appropriate medical judgment, it presented a risk for the patient and required medical or surgical intervention to prevent one of the outcomes listed above.
Time Frame From the first infusion of medication to 30 days after the last one
Hide Outcome Measure Data
Hide Analysis Population Description
All patients who received at least one dose of investigational product were included in the safety dataset.
Arm/Group Title Monoclonal Antibody hu3S193
Hide Arm/Group Description:
hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
Overall Number of Participants Analyzed 29
Measure Type: Number
Unit of Measure: Incidence
1
57.Secondary Outcome
Title Overall Mean Pharmacokinetic (PK) Data (Minimum and Maximum Concentrations)
Hide Description Cmax = Peak (postdosing) Hu3S193 plasma concentration. Cmin = Trough (predosing) Hu3S193 plasma concentration (Cmin). Plasma concentration of Hu3S193 expressed in μg/mL.
Time Frame Predose and Postdose on weeks 1, 2, 3, 4, 5, 7 and 9
Hide Outcome Measure Data
Hide Analysis Population Description
PK samples were analyzed from 10 patients. Dose: 30 mg/m2 every two weeks
Arm/Group Title Pharmacokinetic
Hide Arm/Group Description:
All patients enrolled in the study that received at least 9 doses of investigational product were considered to this analysis.
Overall Number of Participants Analyzed 10
Mean (Standard Deviation)
Unit of Measure: (µg/mL)
Cmin 2.14  (0.92)
Cmax 18.32  (5.66)
58.Secondary Outcome
Title Two-year Overall Survival: Median Time to Death
Hide Description Overall survival was calculated as the time interval between the date of beginning of rescue platinum-based chemotherapy and date of death for any cause.
Time Frame 2-year overall survival rate after the beginning of rescue platinum-based chemotherapy.
Hide Outcome Measure Data
Hide Analysis Population Description
Within the ITT population, 7 patients died and 22 were censored. The median time to death was 25.1 months (95% CI, 16.7 to 32.4 months).
Arm/Group Title hu3S193
Hide Arm/Group Description:
hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
Overall Number of Participants Analyzed 29
Median (95% Confidence Interval)
Unit of Measure: months
25.1
(16.7 to 32.4)
Time Frame They were collected from first application of treatment to 30 days after last. Ongoing AEs were followed up until resolution, start of a new treatment, at the investigator discretion or if they became chronic.
Adverse Event Reporting Description After the 30-day period, the investigator reported the adverse events that in his/her opinion were related to investigational product. In this study, AEs terms were coded using the Medical Dictionary for Regulatory Activities (MedDRA) at the Preferred Term (PT) and System Organ Class (SOC) levels.
 
Arm/Group Title hu3S193
Hide Arm/Group Description hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
All-Cause Mortality
hu3S193
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
hu3S193
Affected / at Risk (%) # Events
Total   03/29 (10.34%)    
Gastrointestinal disorders   
Intestinal obstruction  1  1/29 (3.45%)  1
Vomiting  1  1/29 (3.45%)  1
Musculoskeletal and connective tissue disorders   
Hip fracture  1  1/29 (3.45%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
hu3S193
Affected / at Risk (%) # Events
Total   28/29 (96.55%)    
Blood and lymphatic system disorders   
Anaemia  1  4/29 (13.79%)  4
Cardiac disorders   
Chest pain  1  3/29 (10.34%)  4
Gastrointestinal disorders   
Nausea  1  19/29 (65.52%)  69
Vomiting  1  17/29 (58.62%)  64
Abdominal pain  1  9/29 (31.03%)  16
Constipation  1  7/29 (24.14%)  10
Diarrhoea  1  6/29 (20.69%)  8
Abdominal pain upper  1  3/29 (10.34%)  3
Dry mouth  1  2/29 (6.90%)  2
Dyspepsia  1  2/29 (6.90%)  2
General disorders   
Influenza like illness  1  8/29 (27.59%)  9
Fatigue  1  3/29 (10.34%)  4
Pain  1  2/29 (6.90%)  2
Chills  1  3/29 (10.34%)  3
Hepatobiliary disorders   
Hepatotoxicity  1  2/29 (6.90%)  3
Immune system disorders   
Hypersensitivity  1  9/29 (31.03%)  9
Drug hypersensitivity  1  2/29 (6.90%)  2
Infusion related reaction  1  2/29 (6.90%)  2
Infections and infestations   
Oral herpes  1  2/29 (6.90%)  2
Sinusitis  1  2/29 (6.90%)  3
Investigations   
Neutrophil count decreased  1  5/29 (17.24%)  6
White blood cell count decreased  1  3/29 (10.34%)  3
Musculoskeletal and connective tissue disorders   
Myalgia  1  4/29 (13.79%)  13
Back pain  1  3/29 (10.34%)  4
Pain in extremity  1  2/29 (6.90%)  5
Spinal pain  1  2/29 (6.90%)  2
Nervous system disorders   
Headache  1  9/29 (31.03%)  26
Psychiatric disorders   
Anxiety  1  4/29 (13.79%)  8
Depression  1  2/29 (6.90%)  2
Renal and urinary disorders   
Dysuria  1  2/29 (6.90%)  3
Urinary tract infection  1  2/29 (6.90%)  2
Reproductive system and breast disorders   
Vulvovaginal dryness  1  2/29 (6.90%)  2
Respiratory, thoracic and mediastinal disorders   
Cough  1  6/29 (20.69%)  14
Dyspnoea  1  2/29 (6.90%)  2
Skin and subcutaneous tissue disorders   
Erythema  1  2/29 (6.90%)  3
Pruritus  1  2/29 (6.90%)  3
Vascular disorders   
Hypertension  1  2/29 (6.90%)  2
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Director of Clinical Trials
Organization: Recepta Biopharma
Phone: 55 11 3709-2140
EMail: recepta@receptabio.com.br
Layout table for additonal information
Responsible Party: Recepta Biopharma
ClinicalTrials.gov Identifier: NCT01137071     History of Changes
Other Study ID Numbers: RCP-Ov-01.10
First Submitted: May 31, 2010
First Posted: June 4, 2010
Results First Submitted: September 1, 2016
Results First Posted: December 29, 2016
Last Update Posted: February 23, 2017