Study of Birinapant in Combination With Conatumumab in Subjects With Relapsed Ovarian Cancer
Status: | Completed |
---|---|
Conditions: | Ovarian Cancer |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 4/21/2016 |
Start Date: | November 2013 |
End Date: | December 2015 |
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.
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.
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.
We found this trial at
9
sites
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