Brief Title
Study of Birinapant in Combination With Conatumumab in Subjects With Relapsed Ovarian Cancer
Official Title
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.
Study Phase
Phase 1
Study Type
Interventional
Primary Outcome
Determination of Maximum Tolerated Dose (MTD)
Secondary Outcome
Clinical response as measured by RECIST (v1.1) criteria, CA 125 (GCIG criteria) and progression-free survival (PFS).
Condition
Relapsed Epithelial Ovarian Cancer
Intervention
Birinapant
Study Arms / Comparison Groups
Birinapant with Conatumumab
Description:
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
27
Start Date
November 2013
Completion Date
December 2015
Primary Completion Date
September 2015
Eligibility Criteria
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.
Gender
Female
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
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Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT01940172
Organization ID
TL32711-POC-0090-PTL
Responsible Party
Sponsor
Study Sponsor
TetraLogic Pharmaceuticals
Study Sponsor
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Verification Date
January 2016