Study of Birinapant in Combination With Conatumumab in Subjects With Relapsed Ovarian Cancer

January 13, 2016 updated by: TetraLogic Pharmaceuticals

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

27

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Fresno, California, United States, 39720
        • TetraLogic Research Site
      • San Luis Obispo, California, United States, 93401
        • TetraLogic Research Site
    • Kansas
      • Fairway, Kansas, United States, 66205
        • TetraLogic Research Site
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • TetraLogic Research Site
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • TetraLogic Research Site
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • TetraLogic Research Site
      • Philadelphia, Pennsylvania, United States, 19111
        • TetraLogic Research Site
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • TetraLogic Research Site
    • Texas
      • Dallas, Texas, United States, 75201
        • TetraLogic Research Facility

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Birinapant with Conatumumab
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 Names:
  • TL32711
Drug: Conatumumab
10 mg/kg IV on Day 1 and 15 of each cycle

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Determination of Maximum Tolerated Dose (MTD)
Time Frame: 28 Days
28 Days

Secondary Outcome Measures

Outcome Measure
Time Frame
Clinical response as measured by RECIST (v1.1) criteria, CA 125 (GCIG criteria) and progression-free survival (PFS).
Time Frame: Up to 4 months
Up to 4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

TetraLogic Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2013

Primary Completion (ACTUAL)

September 1, 2015

Study Completion (ACTUAL)

December 1, 2015

Study Registration Dates

First Submitted

September 6, 2013

First Submitted That Met QC Criteria

September 6, 2013

First Posted (ESTIMATE)

September 12, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

January 14, 2016

Last Update Submitted That Met QC Criteria

January 13, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TL32711-POC-0090-PTL

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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