NCT01940172

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Nov 2013

Typical duration for phase_1

Geographic Reach
1 country

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 6, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 12, 2013

Completed
2 months until next milestone

Study Start

First participant enrolled

November 1, 2013

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

January 14, 2016

Status Verified

January 1, 2016

Enrollment Period

1.8 years

First QC Date

September 6, 2013

Last Update Submit

January 13, 2016

Conditions

Relapsed Epithelial Ovarian CancerRelapsed Primary Peritoneal CancerRelapsed Fallopian Tube Cancer

Outcome Measures

Primary Outcomes (1)

  • Determination of Maximum Tolerated Dose (MTD)

    28 Days

Secondary Outcomes (1)

  • Clinical response as measured by RECIST (v1.1) criteria, CA 125 (GCIG criteria) and progression-free survival (PFS).

    Up to 4 months

Study Arms (1)

Birinapant with Conatumumab

EXPERIMENTAL
Drug: BirinapantDrug: Conatumumab

Interventions

BirinapantDRUG

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 );

Also known as: TL32711
Birinapant with Conatumumab
ConatumumabDRUG

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

Birinapant with Conatumumab

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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:
  • New York Heart Association Grade III or IV congestive heart failure.
  • 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.
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

TetraLogic research site

Fresno, California, 39720, United States

Location

TetraLogic Research Site

San Luis Obispo, California, 93401, United States

Location

TetraLogic Research Site

Fairway, Kansas, 66205, United States

Location

TetraLogic Research Site

Boston, Massachusetts, 02114, United States

Location

TetraLogic Research Site

Durham, North Carolina, 27710, United States

Location

TetraLogic Research Site

Philadelphia, Pennsylvania, 19107, United States

Location

TetraLogic Research Site

Philadelphia, Pennsylvania, 19111, United States

Location

TetraLogic Research Site

Nashville, Tennessee, 37203, United States

Location

TetraLogic Research Facility

Dallas, Texas, 75201, United States

Location

MeSH Terms

Conditions

Carcinoma, Ovarian EpithelialFallopian Tube Neoplasms

Interventions

birinapantconatumumab

Condition Hierarchy (Ancestors)

CarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsOvarian NeoplasmsEndocrine Gland NeoplasmsNeoplasms by SiteOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal DisordersFallopian Tube Diseases

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 6, 2013

First Posted

September 12, 2013

Study Start

November 1, 2013

Primary Completion

September 1, 2015

Study Completion

December 1, 2015

Last Updated

January 14, 2016

Record last verified: 2016-01

Locations

US(9)