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

This study has been terminated.
(Total number of pts expected to be enrolled would not be met.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01137071
First Posted: June 4, 2010
Last Update Posted: February 23, 2017
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.
Information provided by (Responsible Party):
Recepta Biopharma
Results First Submitted: September 1, 2016  
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

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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.

Reporting Groups
  Description
hu3S193 hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks

Participant Flow:   Overall Study
    hu3S193
STARTED   29 [1] 
COMPLETED   15 [2] 
NOT COMPLETED   14 
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



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
A total of 37 patients were screened for this study of whom 29 were considered eligible and included in the study (baseline participants).

Reporting Groups
  Description
Monoclonal Antibody hu3S193 hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks

Baseline Measures
   Monoclonal Antibody hu3S193 
Overall Participants Analyzed 
[Units: Participants]
 29 
Age 
[Units: Years]
Mean (Full Range)
 55.69 
 (29 to 67) 
Gender [1] 
[Units: Participants]
Count of Participants
 
Female      29 100.0% 
Male      0   0.0% 
[1] # of Female patients is due to the inclusion criteria number #02: "Female patients of ≥18 years of age"
Race/Ethnicity, Customized [1] 
[Units: Participants]
 
White   24 
Black   1 
Yellow   0 
Brown   4 
Other   0 
[1] Race/Ethnicity/Color was recorded at screening
Region of Enrollment [1] 
[Units: Participants]
 
Brazil   29 
[1] The clinical trial was performed only in Brazil


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   1-year PFS2 Rate After the Beginning of Rescue Platinum-based Chemotherapy   [ Time Frame: 1-Year - From platinum-based rescue chemotherapy start date until documented disease progression or death of any cause whichever occurred first. ]

2.  Secondary:   1-year Disease Progression-free Survival Rate   [ Time Frame: 1 year from the beginning of platinum-based rescue chemotherapy start date ]

3.  Secondary:   Two-year Overall Survival Rate   [ Time Frame: 2-year overall survival rate after the beginning of rescue platinum-based chemotherapy. ]

4.  Secondary:   Safety - Vital Signs - Heart Rate   [ Time Frame: Baseline, week 2 , week 4 and week 27 ]

5.  Secondary:   Safety - Vital Signs - Respiratory Rate   [ Time Frame: Baseline, week 2, week 4 and week 27 ]

6.  Secondary:   Safety - Vital Signs - Systolic and Diastolic Blood Pressure   [ Time Frame: Baseline, week 2, week 4 and week 27 ]

7.  Secondary:   Safety - Vital Signs - Temperature   [ Time Frame: Baseline, week 2, week 4 and week 27 ]

8.  Secondary:   Incidence of Adverse Events (AEs) - Gastrointestinal Disorders   [ Time Frame: From the first infusion of medication to 30 days after the last one ]

9.  Secondary:   Incidence of Adverse Events (AEs) - General Disorders and Administration Site Conditions   [ Time Frame: From the first infusion of medication to 30 days after the last one ]

10.  Secondary:   Incidence of Adverse Events (AEs) - Musculoskeletal and Connective Tissue Disorders   [ Time Frame: From the first infusion of medication to 30 days after the last one ]

11.  Secondary:   Incidence of Adverse Events (AEs) - Immune System Disorders   [ Time Frame: From the first infusion of medication to 30 days after the last one ]

12.  Secondary:   Incidence of Adverse Events (AEs) - Nervous System Disorders   [ Time Frame: From the first infusion of medication to 30 days after the last one ]

13.  Secondary:   Incidence of Adverse Events (AEs) - Investigations   [ Time Frame: From the first infusion of medication to 30 days after the last one ]

14.  Secondary:   Incidence of Adverse Events (AEs) - Respiratory, Thoracic and Mediastinal Disorders   [ Time Frame: From the first infusion of medication to 30 days after the last one ]

15.  Secondary:   Incidence of Adverse Events (AEs) - Infections and Infestations; Gastrointestinal Disorders   [ Time Frame: From the first infusion of medication to 30 days after the last one ]

16.  Secondary:   Incidence of Adverse Events (AEs) - Blood and Lymphatic System Disorders (Anaemia)   [ Time Frame: From the first infusion of medication to 30 days after the last one ]

17.  Secondary:   Incidence of Adverse Events (AEs) - Infections and Infestations; Respiratory, Thoracic and Mediastinal Disorders   [ Time Frame: From the first infusion of medication to 30 days after the last one ]

18.  Secondary:   Incidence of Adverse Events (AEs) - Psychiatric Disorders (Anxiety)   [ Time Frame: From the first infusion of medication to 30 days after the last one ]

19.  Secondary:   Incidence of Adverse Events (AEs) - Vascular Disorders   [ Time Frame: From the first infusion of medication to 30 days after the last one ]

20.  Secondary:   Incidence of Adverse Events (AEs) - Cardiac Disorders; General Disorders and Administration Site Conditions; Respiratory, Thoracic and Mediastinal Disorders (Chest Pain)   [ Time Frame: From the first infusion of medication to 30 days after the last one ]

21.  Secondary:   Incidence of Adverse Events (AEs) - General Disorders and Administration Site Conditions; Musculoskeletal and Connective Tissue Disorders (Chills)   [ Time Frame: From the first infusion of medication to 30 days after the last one ]

22.  Secondary:   Incidence of Adverse Events (AEs) - Skin and Subcutaneous Tissue Disorders   [ Time Frame: From the first infusion of medication to 30 days after the last one ]

23.  Secondary:   Incidence of Adverse Events (AEs) - Ear and Labyrinth Disorders   [ Time Frame: From the first infusion of medication to 30 days after the last one ]

24.  Secondary:   Incidence of Adverse Events (AEs) - Hepatobiliary Disorders; Injury, Poisoning and Procedural Complications (Hepatotoxicity)   [ Time Frame: From the first infusion of medication to 30 days after the last one ]

25.  Secondary:   Incidence of Adverse Events (AEs) - Immune System Disorders; General Disorders and Administration Site Conditions; Injury, Poisoning and Procedural Complications (Infusion Related Reaction)   [ Time Frame: From the first infusion of medication to 30 days after the last one ]

26.  Secondary:   Incidence of Adverse Events (AEs) - Immune System Disorders; Respiratory, Thoracic and Mediastinal Disorders   [ Time Frame: From the first infusion of medication to 30 days after the last one ]

27.  Secondary:   Incidence of Adverse Events (AEs) - Musculoskeletal and Connective Tissue Disorders; General Disorders and Administration Site Conditions; Nervous System Disorders (Spinal Pain)   [ Time Frame: From the first infusion of medication to 30 days after the last one ]

28.  Secondary:   Incidence of Adverse Events (AEs) - Musculoskeletal and Connective Tissue Disorders; Injury, Poisoning and Procedural Complications   [ Time Frame: From the first infusion of medication to 30 days after the last one ]

29.  Secondary:   Incidence of Adverse Events (AEs) - Psychiatric Disorders (Depression)   [ Time Frame: From the first infusion of medication to 30 days after the last one ]

30.  Secondary:   Incidence of Adverse Events (AEs) - Renal and Urinary Disorders (Dysuria)   [ Time Frame: From the first infusion of medication to 30 days after the last one ]

31.  Secondary:   Incidence of Adverse Events (AEs) - Renal and Urinary Disorders; Infections and Infestations (Urinary Tract Infection)   [ Time Frame: From the first infusion of medication to 30 days after the last one ]

32.  Secondary:   Incidence of Adverse Events (AEs) - Reproductive System and Breast Disorders (Vulvovaginal Dryness)   [ Time Frame: From the first infusion of medication to 30 days after the last one ]

33.  Secondary:   Incidence of Adverse Events (AEs) - Respiratory, Thoracic and Mediastinal Disorders; Cardiac Disorders (Dyspnoea)   [ Time Frame: From the first infusion of medication to 30 days after the last one ]

34.  Secondary:   Incidence of Adverse Events (AEs) - Skin and Subcutaneous Tissue Disorders; Injury, Poisoning and Procedural Complications   [ Time Frame: From the first infusion of medication to 30 days after the last one ]

35.  Secondary:   Incidence of Adverse Events (AEs) - Cardiac Disorders; Vascular Disorders; Nervous System Disorders (Dizziness)   [ Time Frame: From the first infusion of medication to 30 days after the last one ]

36.  Secondary:   Incidence of Adverse Events (AEs) - Ear and Labyrinth Disorders; Nervous System Disorders (Vertigo)   [ Time Frame: From the first infusion of medication to 30 days after the last one ]

37.  Secondary:   Incidence of Adverse Events (AEs) - Endocrine Disorders; Metabolism and Nutrition Disorders (Hyperglycaemia)   [ Time Frame: From the first infusion of medication to 30 days after the last one ]

38.  Secondary:   Incidence of Adverse Events (AEs) - Eye Disorders (Ocular Hyperaemia)   [ Time Frame: From the first infusion of medication to 30 days after the last one ]

39.  Secondary:   Incidence of Adverse Events (AEs) - Gastrointestinal Disorders; Infections and Infestations; Respiratory, Thoracic and Mediastinal Disorders (Pharyngitis)   [ Time Frame: From the first infusion of medication to 30 days after the last one ]

40.  Secondary:   Incidence of Adverse Events (AEs) - Gastrointestinal Disorders; Reproductive System and Breast Disorders; Renal and Urinary Disorders (Pelvic Pain)   [ Time Frame: From the first infusion of medication to 30 days after the last one ]

41.  Secondary:   Incidence of Adverse Events (AEs) - Gastrointestinal Disorders; Vascular Disorders (Anal Haemorrhage)   [ Time Frame: From the first infusion of medication to 30 days after the last one ]

42.  Secondary:   Incidence of Adverse Events (AEs) - General Disorders and Administration Site Conditions; Injury, Poisoning and Procedural Complications (Hyperthermia)   [ Time Frame: From the first infusion of medication to 30 days after the last one ]

43.  Secondary:   Incidence of Adverse Events (AEs) - General Disorders and Administration Site Conditions; Injury, Poisoning and Procedural Complications (Catheter Site Inflammation)   [ Time Frame: From the first infusion of medication to 30 days after the last one ]

44.  Secondary:   Incidence of Adverse Events (AEs) - Immune System Disorders; Blood and Lymphatic System Disorders; Injury, Poisoning and Procedural Complications (Transfusion Reaction)   [ Time Frame: From the first infusion of medication to 30 days after the last one ]

45.  Secondary:   Incidence of Adverse Events (AEs) - Infections and Infestations; Respiratory, Thoracic and Mediastinal Disorders (Bronchitis)   [ Time Frame: From the first infusion of medication to 30 days after the last one ]

46.  Secondary:   Incidence of Adverse Events (AEs) - Infections and Infestations; Renal and Urinary Disorders (Urinary Tract Infection Bacterial)   [ Time Frame: From the first infusion of medication to 30 days after the last one ]

47.  Secondary:   Incidence of Adverse Events (AEs) - Investigations (Blood Cholesterol Increased)   [ Time Frame: From the first infusion of medication to 30 days after the last one ]

48.  Secondary:   Incidence of Adverse Events (AEs) - Musculoskeletal and Connective Tissue Disorders; General Disorders and Administration Site Conditions; Renal and Urinary Disorders (Flank Pain)   [ Time Frame: From the first infusion of medication to 30 days after the last one ]

49.  Secondary:   Incidence of Adverse Events (AEs) - Nervous System Disorders; Psychiatric Disorders; Respiratory, Thoracic and Mediastinal Disorders (Hoarseness)   [ Time Frame: From the first infusion of medication to 30 days after the last one ]

50.  Secondary:   Incidence of Adverse Events (AEs) - Psychiatric Disorders; Nervous System Disorders (Insomnia)   [ Time Frame: From the first infusion of medication to 30 days after the last one ]

51.  Secondary:   Incidence of Adverse Events (AEs) - Skin and Subcutaneous Tissue Disorders; Infections and Infestations (Tinea Pedis)   [ Time Frame: From the first infusion of medication to 30 days after the last one ]

52.  Secondary:   Incidence of Adverse Events (AEs) - Skin and Subcutaneous Tissue Disorders; Reproductive System and Breast Disorders (Vulvovaginal Pruritus)   [ Time Frame: From the first infusion of medication to 30 days after the last one ]

53.  Secondary:   Incidence of Adverse Events (AEs) - Vascular Disorders; Gastrointestinal Disorders (Haemorrhoids)   [ Time Frame: From the first infusion of medication to 30 days after the last one ]

54.  Secondary:   Incidence of Adverse Events (AEs) - Vascular Disorders; Respiratory, Thoracic and Mediastinal Disorders (Epistaxis)   [ Time Frame: From the first infusion of medication to 30 days after the last one ]

55.  Secondary:   Incidence of Serious Adverse Events (SAEs) - Gastrointestinal Disorders   [ Time Frame: From the first infusion of medication to 30 days after the last one ]

56.  Secondary:   Incidence of Serious Adverse Events (SAEs) - Musculoskeletal and Connective Tissue Disorders - Hip Fracture   [ Time Frame: From the first infusion of medication to 30 days after the last one ]

57.  Secondary:   Overall Mean Pharmacokinetic (PK) Data (Minimum and Maximum Concentrations)   [ Time Frame: Predose and Postdose on weeks 1, 2, 3, 4, 5, 7 and 9 ]

58.  Secondary:   Two-year Overall Survival: Median Time to Death   [ Time Frame: 2-year overall survival rate after the beginning of rescue platinum-based chemotherapy. ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Director of Clinical Trials
Organization: Recepta Biopharma
phone: 55 11 3709-2140
e-mail: recepta@receptabio.com.br



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