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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-11-30

Study Completion Date

2015-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Birinapant for Advanced Ovarian, Fallopian Tube, and Peritoneal Cancer

NCT01681368

Epithelial Ovarian Cancer Peritoneal Neoplasms Fallopian Tube Neoplasms

TERMINATED PHASE2

18F-CP18 Imaging Studies for Cancer Treatment With Birinapant

NCT01766622

Ovarian Neoplasms Ovarian Cancer Fallopian Tube Neoplasms +1 more

WITHDRAWN PHASE2

Panitumumab and Gemcitabine in Relapsed Ovarian Cancer

NCT01296035

Ovarian Cancer Fallopian Tube Cancer Primary Peritoneal Cancer

TERMINATED PHASE2

Birinapant and Carboplatin in Treating Patients and Targeting Recurrent High Grade Ovarian, Fallopian Tube, or Primary Peritoneal Cancer (HGSOC)

NCT02756130

High Grade Fallopian Tube Serous Adenocarcinoma High Grade Ovarian Serous Adenocarcinoma Primary Peritoneal High Grade Serous Adenocarcinoma +3 more

WITHDRAWN PHASE1/PHASE2

Niraparib and Copanlisib in Treating Patients With Recurrent Endometrial, Ovarian, Primary Peritoneal, or Fallopian Tube Cancer

NCT03586661

Deleterious BRCA1 Gene Mutation Deleterious BRCA2 Gene Mutation Endometrial Adenocarcinoma +8 more

ACTIVE_NOT_RECRUITING PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Relapsed Epithelial Ovarian Cancer Relapsed Primary Peritoneal Cancer Relapsed Fallopian Tube Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Birinapant with Conatumumab

Group Type EXPERIMENTAL

Birinapant

Intervention Type DRUG

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 );

Conatumumab

Intervention Type DRUG

10 mg/kg IV on Day 1 and 15 of each cycle

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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 );

Intervention Type DRUG

Conatumumab

10 mg/kg IV on Day 1 and 15 of each cycle

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

TL32711

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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

* 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.

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No