Relapsed Epithelial Ovarian Cancer Clinical Trial
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
| Verified date | January 2016 |
| Source | TetraLogic Pharmaceuticals |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 27 |
| Est. completion date | December 2015 |
| Est. primary completion date | September 2015 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 18 Years and older |
| Eligibility |
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. |
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| United States | TetraLogic Research Site | Boston | Massachusetts |
| United States | TetraLogic Research Facility | Dallas | Texas |
| United States | TetraLogic Research Site | Durham | North Carolina |
| United States | TetraLogic Research Site | Fairway | Kansas |
| United States | TetraLogic research site | Fresno | California |
| United States | TetraLogic Research Site | Nashville | Tennessee |
| United States | TetraLogic Research Site | Philadelphia | Pennsylvania |
| United States | TetraLogic Research Site | Philadelphia | Pennsylvania |
| United States | TetraLogic Research Site | San Luis Obispo | California |
| Lead Sponsor | Collaborator |
|---|---|
| TetraLogic Pharmaceuticals |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Determination of Maximum Tolerated Dose (MTD) | 28 Days | Yes | |
| Secondary | Clinical response as measured by RECIST (v1.1) criteria, CA 125 (GCIG criteria) and progression-free survival (PFS). | Up to 4 months | No |