Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 3 for:    "Recepta" "hu3S193"
Previous Study | Return to List | Next Study

Hu3S193 in Treating Women With Ovarian Epithelial, Primary Peritoneal, or Fallopian Tube Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00617773
Recruitment Status : Completed
First Posted : February 18, 2008
Results First Posted : November 26, 2013
Last Update Posted : November 26, 2013
Sponsor:
Information provided by (Responsible Party):
Recepta Biopharma

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Fallopian Tube Cancer
Ovarian Cancer
Primary Peritoneal Cancer
Intervention Biological: hu3S193
Enrollment 31
Recruitment Details This was a brazilian, multicentric clinical trial. From June 20, 2008 to July 13, 2010 (recruitment period of 24 months) a total of 51 patients were screened for this study, of whom 31 were considered eligible and received at least one dose of the investigational product and 20 were considered non-eligible.
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 : 20 mg/m2, intravenous, weekly for a maximum of 3 cycles (of 8 weeks each)
Period Title: Overall Study
Started 31
Completed 7 [1]
Not Completed 24
Reason Not Completed
Physician Decision             1
Lack of compliance with the protocol             1
Withdrawal by Subject             1
Death             1
Progressive disease             19
Protocol Violation             1
[1]
Patients COMPLETED were evaluated as having no disease progression at the end of cycle 3.
Arm/Group Title hu3S193
Hide Arm/Group Description hu3S193 : 20 mg/m2, intravenous, weekly for a maximum of 3 cycles (of 8 weeks each)
Overall Number of Baseline Participants 31
Hide Baseline Analysis Population Description
The baseline descriptive analyses were performed for the safety population. Lewis Y antigen expression and blood type were also analyzed for this population.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 31 participants
<=18 years
0
   0.0%
Between 18 and 65 years
27
  87.1%
>=65 years
4
  12.9%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 31 participants
Female
31
 100.0%
Male
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Brazil Number Analyzed 31 participants
31
Expression of the Lewis Y antigen in tumor tissue   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 31 participants
Positive (+1) 14
Positive (+2) 6
Positive (+3) 8
Positive (+4) 3
[1]
Measure Description:

Expression of Lewis Y was investigated by immunohistochemistry on primary or metastatic tumor biopsies. To determine Lewis Y expression levels, a semi-quantitative approach was used, which considered cytoplasm and membrane compartments independently. The score taken into account was from the higher expression observed, either cytoplasm or membrane.

Participants with positive expression of Lewis Y in tumor were scored, according to the percentage of positively stained cells, into the following categories: +4 (>75% positive cells); +3 (51 to 75%); +2 (26 to 50%); and +1 (1 to 25%).

ABO blood type  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 31 participants
Type A 11
Type B 1
Type AB 2
Type O 17
1.Primary Outcome
Title Best Overall Response
Hide Description

Best response recorded from the start of treatment until disease progression/recurrence. Includes all patients evaluable for efficacy, regardless of used criteria: RECIST or CA-125 (Cancer Antigen 125).

Evaluation of target lesions: Complete Response (CR), resolution of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter (LD sum) of target lesions, taking as reference the baseline LD sum; Progressive Disease (PD), a 20% increase in LD sum of target lesions or the appearance of new lesion(s); Stable Disease (SD), no sufficient shrinkage to qualify as PR nor sufficient increase to qualify as PD. Evaluation of non-target lesions: CR, resolution of all non-target lesions and normalization of CA-125 level; SD, persistence of one or more non-target lesions and/or maintenance of CA-125 level above the normal limits; PD, appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions.

Time Frame From start of study treatment until the end of Cycle 1 (8 weeks), Cycle 2 (16 weeks) or Cycle 3 (24 weeks).
Hide Outcome Measure Data
Hide Analysis Population Description
All patients enrolled in the study that received at least 4 doses of investigational product were considered to the efficacy evaluation.
Arm/Group Title hu3S193
Hide Arm/Group Description:
hu3S193 : 20 mg/m2, intravenous, weekly for a maximum of 3 cycles (of 8 weeks each)
Overall Number of Participants Analyzed 26
Measure Type: Number
Unit of Measure: participants
Complete response 0
Partial response 0
Stable disease 13
Disease progression 11
Unknown 2
2.Secondary Outcome
Title Number of Participants With Adverse Events and Serious Adverse Events
Hide Description A listing of all adverse events is located in the Reported Adverse Event module.
Time Frame From the first dose of investigational product up to 30 days after the last dose of investigational product
Hide Outcome Measure Data
Hide Analysis Population Description
All patients enrolled in the study that received at least 1 dose of investigational product were considered for safety evaluation.
Arm/Group Title hu3S193
Hide Arm/Group Description:
hu3S193 : 20 mg/m2, intravenous, weekly for a maximum of 3 cycles (of 8 weeks each)
Overall Number of Participants Analyzed 31
Measure Type: Number
Unit of Measure: participants
Adverse Events 31
Serious Adverse Events 9
3.Secondary Outcome
Title Number of Participants With Adverse Events Reasonably Related to the Investigational Product (Incidence Greater Than 5%).
Hide Description Adverse events with possible, probable or definite relationship to the investigational product were considered to be reasonably related.
Time Frame From the first dose of investigational product up to 30 days after the last dose of investigational product
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title hu3S193
Hide Arm/Group Description:
hu3S193 : 20 mg/m2, intravenous, weekly for a maximum of 3 cycles (of 8 weeks each)
Overall Number of Participants Analyzed 31
Measure Type: Number
Unit of Measure: participants
Adverse event: Nausea 5
Adverse event: Fatigue 4
Adverse event: Diarrhoea 3
Adverse event: Hypersensitivity 3
Adverse event: Hypertension 3
Adverse event: Pyrexia 3
Adverse event: Constipation 2
Adverse event: Dry mouth 2
Adverse event: Haemoglobin abnormal 2
Adverse event: Tremor 2
Adverse event: Urticaria 2
4.Secondary Outcome
Title Mean Cmax and Cmin of Hu3S193 Relating to the First 4 Doses.
Hide Description Cmax = Peak (post-dosing) IP (Investigational Product) plasma concentration. Cmin = Trough (pre-dosing) IP plasma concentration (Cmin). Plasma concentration of Hu3S193 expressed in µg/mL.
Time Frame Pre-dose (within 10 minutes) and Post-dose (5 minutes after completion of infusion) on weeks 1, 2, 3, and 4 of Cycle 1.
Hide Outcome Measure Data
Hide Analysis Population Description
All patients enrolled in the study that received at least 4 doses of investigational product were considered to this analysis.
Arm/Group Title hu3S193
Hide Arm/Group Description:
hu3S193 : 20 mg/m2, intravenous, weekly for a maximum of 3 cycles (of 8 weeks each)
Overall Number of Participants Analyzed 26
Mean (Standard Deviation)
Unit of Measure: µg/mL
Mean Cmax of Hu3S193 16.7  (3.7)
Mean Cmin of Hu3S193 2.1  (1)
5.Secondary Outcome
Title Mean Cmax and Cmin of Hu3S193 Relating to the First 8 Doses
Hide Description Cmax = Peak (post-dosing) IP plasma concentration. Cmin = Trough (pre-dosing) IP plasma concentration (Cmin). Plasma concentration of Hu3S193 expressed in µg/mL.
Time Frame Pre-dose (within 10 minutes) and Post-dose (5 minutes after completion of infusion) on weeks 1, 2, 3, 4, 5, 6, 7 and 8 of Cycle 1.
Hide Outcome Measure Data
Hide Analysis Population Description
All patients enrolled in the study that received at least 8 doses of investigational product were considered to this analysis.
Arm/Group Title hu3S193
Hide Arm/Group Description:
hu3S193 : 20 mg/m2, intravenous, weekly for a maximum of 3 cycles (of 8 weeks each)
Overall Number of Participants Analyzed 17
Mean (Standard Deviation)
Unit of Measure: µg/mL
Mean Cmax of Hu3S193 10.9  (4.7)
Mean Cmin of Hu3S193 2.3  (0.8)
6.Other Pre-specified Outcome
Title Clinical Benefit
Hide Description

The clinical benefit was calculated considering all patients with objective response rate (CR + PR) or stable disease (SD) for at least 24 weeks according RECIST or CA-125 if patients were non-assessable or when assessment by RECIST was unknown.

Clinical benefit = 100% x (Number of patients with objective response + Number of patients with stable disease for at least 24 weeks) / Number of patients included in the efficacy population.

The evaluation of target and non-target lesions is described at the Outcome Measure titled "Best Overall Response". CR: Complete Response; PR: Partial Response; SD: Stable Disease.

Time Frame From start of study treatment until the end of Cycle 3 (24 weeks).
Hide Outcome Measure Data
Hide Analysis Population Description
All patients enrolled in the study that received at least 4 doses of investigational product and that were evaluable for response were considered to this analysis.
Arm/Group Title hu3S193
Hide Arm/Group Description:
hu3S193 : 20 mg/m2, intravenous, weekly for a maximum of 3 cycles (of 8 weeks each)
Overall Number of Participants Analyzed 24
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
25.0
(9.77 to 46.71)
7.Other Pre-specified Outcome
Title Progression Free Survival (PFS)
Hide Description Progression free survival (PFS) is defined as the duration of time from start of treatment to time of disease progression.
Time Frame From the first day of the investigational product administration until documentation of disease progression or death due to any cause (whichever occurred first). An average of 16.5549 weeks.
Hide Outcome Measure Data
Hide Analysis Population Description
All patients enrolled in the study that received at least 4 doses of investigational product and that were evaluable for response were considered to this analysis.
Arm/Group Title hu3S193
Hide Arm/Group Description:
hu3S193 : 20 mg/m2, intravenous, weekly for a maximum of 3 cycles (of 8 weeks each)
Overall Number of Participants Analyzed 26
Median (Full Range)
Unit of Measure: weeks
8.4286
(4.1429 to 87.0000)
8.Other Pre-specified Outcome
Title Overall Survival
Hide Description Measured from the beginning of therapy until the date of death or for patients without a known date of death, they will be censored at the date they were last known to be alive.
Time Frame From start of study treatment until death or the date that patients were last known to be alive. An average of 56.126 weeks.
Hide Outcome Measure Data
Hide Analysis Population Description
All patients enrolled in the study that received at least 4 doses of investigational product were considered to this analysis.
Arm/Group Title hu3S193
Hide Arm/Group Description:
hu3S193 : 20 mg/m2, intravenous, weekly for a maximum of 3 cycles (of 8 weeks each)
Overall Number of Participants Analyzed 26
Median (Full Range)
Unit of Measure: weeks
67.214
(4.714 to 131.143)
9.Other Pre-specified Outcome
Title 12-Month Survival Rate
Hide Description Rate of patients alive 12 months after starting therapy with the investigational product.
Time Frame 12 months from the start of study treatment.
Hide Outcome Measure Data
Hide Analysis Population Description
All patients enrolled in the study that received at least 4 doses of investigational product were considered to this analysis.
Arm/Group Title hu3S193
Hide Arm/Group Description:
hu3S193 : 20 mg/m2, intravenous, weekly for a maximum of 3 cycles (of 8 weeks each)
Overall Number of Participants Analyzed 26
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
57.7
(38.7 to 76.7)
10.Post-Hoc Outcome
Title Progression Free Survival in Patients With and Without Ascites at Baseline
Hide Description Progression free survival (PFS) is defined as the duration of time from start of treatment to time of disease progression.
Time Frame From the first day of the investigational product administration until documentation of disease progression or death due to any cause (whichever occurred first) while the patient was on treatment, non-treatment period, or during the long-term follow-up.
Hide Outcome Measure Data
Hide Analysis Population Description
All patients enrolled in the study that received at least 4 doses of investigational product were considered to this analysis.
Arm/Group Title hu3S193
Hide Arm/Group Description:
hu3S193 : 20 mg/m2, intravenous, weekly for a maximum of 3 cycles (of 8 weeks each)
Overall Number of Participants Analyzed 26
Median (95% Confidence Interval)
Unit of Measure: weeks
PFS in patients with ascites at baseline (n=9)
6.0000
(4.7143 to 8.2857)
PFS in patients without ascites at baseline (n=17)
16.1429
(7.1429 to 32.0000)
11.Post-Hoc Outcome
Title Progression Free Survival in Patients With and Without Visceral Disease at Baseline
Hide Description Progression free survival (PFS) is defined as the duration of time from start of treatment to time of disease progression
Time Frame From the first day of the investigational product administration until documentation of disease progression or death due to any cause (whichever occurred first) while the patient was on treatment, non-treatment period, or during the long-term follow-up.
Hide Outcome Measure Data
Hide Analysis Population Description
All patients enrolled in the study that received at least 4 doses of investigational product and that were assessed for visceral disease at baseline were considered for this analysis.
Arm/Group Title hu3S193
Hide Arm/Group Description:
hu3S193 : 20 mg/m2, intravenous, weekly for a maximum of 3 cycles (of 8 weeks each)
Overall Number of Participants Analyzed 25
Median (95% Confidence Interval)
Unit of Measure: weeks
PFS in patients with visceral disease (n=5)
6.1429
(4.1429 to 28.0000)
PFS in patients without visceral disease (n=20)
8.9286
(5.4286 to 18.2857)
12.Post-Hoc Outcome
Title Progression Free Survival in Patients Without Ascites and no Visceral Disease at Baseline Versus Patients With Ascites and/or Visceral Disease at Baseline
Hide Description Progression free survival (PFS) is defined as the duration of time from start of treatment to time of disease progression.
Time Frame From the first day of the investigational product administration until documentation of disease progression or death due to any cause (whichever occurred first) while the patient was on treatment, non-treatment period, or during the long-term follow-up.
Hide Outcome Measure Data
Hide Analysis Population Description
All patients enrolled in the study that received at least 4 doses of investigational product and that were assessed for visceral disease and ascites at baseline were considered for this analysis.
Arm/Group Title hu3S193
Hide Arm/Group Description:
hu3S193 : 20 mg/m2, intravenous, weekly for a maximum of 3 cycles (of 8 weeks each)
Overall Number of Participants Analyzed 25
Median (95% Confidence Interval)
Unit of Measure: weeks
Without ascites and no visceral disease (n=13)
16.1429
(7.1429 to 32.0000)
With ascites and/or visceral disease (n=12)
6.0714
(4.7143 to 8.2857)
Time Frame From the first dose of investigational product up to 30 days after the last dose of investigational product.
Adverse Event Reporting Description At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings.
 
Arm/Group Title hu3S193
Hide Arm/Group Description hu3S193 : 20 mg/m2, intravenous, weekly for a maximum of 3 cycles (of 8 weeks each)
All-Cause Mortality
hu3S193
Affected / at Risk (%)
Total   --/--    
Hide Serious Adverse Events
hu3S193
Affected / at Risk (%) # Events
Total   9/31 (29.03%)    
Gastrointestinal disorders   
Intestinal obstruction  1  2/31 (6.45%)  3
Constipation  1  1/31 (3.23%)  1
Vomiting  1  1/31 (3.23%)  1
General disorders   
Asthenia; Performance status decreased  1  1/31 (3.23%)  1
Infections and infestations   
Bacteraemia  1  1/31 (3.23%)  1
Sepsis  1  1/31 (3.23%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Metastases to central nervous system  1  1/31 (3.23%)  1
Nervous system disorders   
Syncope  1  1/31 (3.23%)  1
Psychiatric disorders   
Depression  1  1/31 (3.23%)  1
Reproductive system and breast disorders   
Genital haemorrhage  1  1/31 (3.23%)  1
Respiratory, thoracic and mediastinal disorders   
Pleural effusion  1  1/31 (3.23%)  1
Pulmonary embolism  1  1/31 (3.23%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (11.1)
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
hu3S193
Affected / at Risk (%) # Events
Total   31/31 (100.00%)    
Gastrointestinal disorders   
Nausea  1  13/31 (41.94%)  21
Vomiting  1  13/31 (41.94%)  26
Abdominal pain  1  12/31 (38.71%)  16
Constipation  1  10/31 (32.26%)  14
Diarrhoea  1  10/31 (32.26%)  14
Anorexia  1  5/31 (16.13%)  10
Abdominal distension  1  4/31 (12.90%)  6
Dyspepsia  1  4/31 (12.90%)  5
Dry mouth  1  3/31 (9.68%)  3
Intestinal obstruction  1  2/31 (6.45%)  4
General disorders   
Fatigue  1  8/31 (25.81%)  15
Pyrexia  1  6/31 (19.35%)  8
Influenza like illness  1  5/31 (16.13%)  6
Oedema peripheral  1  4/31 (12.90%)  4
Chest pain  1  3/31 (9.68%)  4
Catheter site pain  1  2/31 (6.45%)  2
Immune system disorders   
Hypersensitivity  1  3/31 (9.68%)  5
Infections and infestations   
Upper respiratory tract infection  1  3/31 (9.68%)  3
Urinary tract infection  1  3/31 (9.68%)  3
Sinusitis  1  2/31 (6.45%)  2
Investigations   
Haemoglobin abnormal  1  5/31 (16.13%)  9
Musculoskeletal and connective tissue disorders   
Pain in extremity  1  8/31 (25.81%)  10
Back pain  1  4/31 (12.90%)  5
Muscle spasms  1  2/31 (6.45%)  3
Nervous system disorders   
Tremor  1  5/31 (16.13%)  5
Headache  1  4/31 (12.90%)  5
Psychiatric disorders   
Insomnia  1  3/31 (9.68%)  3
Renal and urinary disorders   
Dysuria  1  2/31 (6.45%)  2
Reproductive system and breast disorders   
Vaginal haemorrhage  1  4/31 (12.90%)  6
Respiratory, thoracic and mediastinal disorders   
Cough  1  6/31 (19.35%)  6
Dyspnoea  1  3/31 (9.68%)  7
Pleural effusion  1  2/31 (6.45%)  3
Rhinitis allergic  1  2/31 (6.45%)  3
Skin and subcutaneous tissue disorders   
Urticaria  1  3/31 (9.68%)  3
Vascular disorders   
Hypertension  1  3/31 (9.68%)  10
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (11.1)
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: Dr. Oren Smaletz, M.D., Medical Director
Organization: Recepta Biopharma
Phone: 55 11 3709-2140
EMail: oren.smaletz@receptabiopharma.com.br
Layout table for additonal information
Responsible Party: Recepta Biopharma
ClinicalTrials.gov Identifier: NCT00617773    
Other Study ID Numbers: RCPOv01-06
RCP-Ov-01.06 ( Other Identifier: Recepta Biopharma )
First Submitted: February 15, 2008
First Posted: February 18, 2008
Results First Submitted: May 15, 2013
Results First Posted: November 26, 2013
Last Update Posted: November 26, 2013