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Study of Birinapant in Combination With Conatumumab in Subjects With Relapsed Ovarian 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: NCT01940172
Recruitment Status : Completed
First Posted : September 12, 2013
Last Update Posted : January 14, 2016
Sponsor:
Information provided by (Responsible Party):
TetraLogic Pharmaceuticals

Tracking Information
First Submitted Date  ICMJE September 6, 2013
First Posted Date  ICMJE September 12, 2013
Last Update Posted Date January 14, 2016
Study Start Date  ICMJE November 2013
Actual Primary Completion Date September 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 6, 2013)
Determination of Maximum Tolerated Dose (MTD) [ Time Frame: 28 Days ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 6, 2013)
Clinical response as measured by RECIST (v1.1) criteria, CA 125 (GCIG criteria) and progression-free survival (PFS). [ Time Frame: Up to 4 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of Birinapant in Combination With Conatumumab in Subjects With Relapsed Ovarian Cancer
Official Title  ICMJE A Phase 1b, Open-label, Non-randomized Multicenter Study of Birinapant in Combination With Conatumumab in Subjects With Relapsed Epithelial Ovarian Cancer, Primary Peritoneal Cancer or Fallopian Tube Cancer
Brief Summary

This is a dose escalation study in female subjects with relapsed ovarian cancer (including epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer). Approximately 30 to 40 subjects will be administered a combination of conatumumab and birinapant.

In the initial dose-escalation stage of the study, adult female subjects will receive conatumumab in combination with increasing doses of birinapant in dose-escalation cohorts to determine the MTD of birinapant when administered with a fixed dose of conatumumab.

In safety expansion stage, adult female subjects will receive conatumumab in combination with birinapant at the MTD of the combination.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Relapsed Epithelial Ovarian Cancer
  • Relapsed Primary Peritoneal Cancer
  • Relapsed Fallopian Tube Cancer
Intervention  ICMJE
  • Drug: Birinapant

    Dose Escalation:

    Dose Level (1) - 13 mg/m2 (twice a week for 3 of 4 weeks); Dose Level (-1) - 11 mg/m2 (twice a week for 3 of 4 weeks); Dose Level (2) - 13 mg/m2 (twice weekly for 4 weeks );

    Other Name: TL32711
  • Drug: Conatumumab
    10 mg/kg IV on Day 1 and 15 of each cycle
Study Arms  ICMJE Experimental: Birinapant with Conatumumab
Interventions:
  • Drug: Birinapant
  • Drug: Conatumumab
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 13, 2016)
27
Original Estimated Enrollment  ICMJE
 (submitted: September 6, 2013)
40
Actual Study Completion Date  ICMJE December 2015
Actual Primary Completion Date September 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria-If subject:

  • Is a women who is at least 18 years of age.
  • Has a negative serum pregnancy test at screening for women of childbearing potential.
  • Pathologically confirmed ovarian cancer (epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer) may have had a maximum of 3 prior systemic chemotherapy regimens (excluding hormonal therapies and investigational agents).
  • Has a performance status of 0 or 1 by the Eastern Cooperative Oncology Group (ECOG) scale.
  • Has a measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria AND meet Gynecologic Cancer InterGroup (GCIG) CA 125 criteria.
  • Has a life expectancy of at least 3 months.
  • Has adequate liver, renal, pancreatic, coagulation and bone marrow function.

Exclusion Criteria-If subject:

  • Has symptomatic or uncontrolled brain metastases requiring current treatment (<8 weeks from last cranial radiation treatment or <4 weeks from last steroid treatment).
  • Has known intolerance to any of the study drugs or any of their excipients.
  • Has known or suspected diagnosis of human immunodeficiency virus (HIV) or chronic active Hepatitis B or C.
  • Has uncontrolled hypertension defined as blood pressure >160/100 mmHg without medication, or not controlled despite medications.
  • Has received systemic chemotherapy, hormonal therapy, immunotherapy, anti-tumor necrosis factor (TNF) therapies, experimental or approved anticancer proteins/antibodies therapy

    ≤28 days before enrollment.

  • Has impaired cardiac function or clinically significant cardiac disease including the following:

    1. New York Heart Association Grade III or IV congestive heart failure.
    2. Myocardial infarction within the last 12 months prior to dosing with birinapant.
  • Has a QT interval corrected for heart rate (QTcB) >480 msec (including subjects on medication). Subjects with a ventricular pacemaker for whom QT interval is not measurable may be eligible.
  • Has a lack of recovery of prior adverse non-hematological events to Grade ≤1 severity (National Cancer Institute Common Terminology Criteria for Adverse Events [NCI CTCAE] v4.03) (except alopecia) due to therapy administered prior to the initiation of study drug dosing.
  • Has any concurrent disease and/or medical condition that, in the opinion of the Investigator, would prevent the subject's participation, render the subject at excessive risk (including excessive risks due to the toxicity profile of the planned combination chemotherapeutic regimen), or limit the subject's compliance with the protocol's required evaluations.
  • Has a prior history of cranial nerve palsy.
  • Has autoimmune diseases or inflammatory diseases, for example, active rheumatoid arthritis, active inflammatory bowel disease or any chronic inflammatory conditions.
  • Has pseudomyxoma, mesothelioma, unknown primary tumor, sarcoma, neuroendocrine histology, clear cell or mucinous histology or subjects with borderline ovarian cancer.
  • Requires concomitant chronic use of anti-TNF therapies, corticosteroids or nonsteroidal anti- inflammatory drugs (NSAIDS). Intermittent use (7 or fewer days per 14 days) of corticosteroids as pre-medications is allowed.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01940172
Other Study ID Numbers  ICMJE TL32711-POC-0090-PTL
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party TetraLogic Pharmaceuticals
Study Sponsor  ICMJE TetraLogic Pharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account TetraLogic Pharmaceuticals
Verification Date January 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP