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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by TetraLogic Pharmaceuticals
Sponsor:
Information provided by (Responsible Party):
TetraLogic Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01940172
First received: September 6, 2013
Last updated: May 30, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention Phase
Relapsed Epithelial Ovarian Cancer
Relapsed Primary Peritoneal Cancer
Relapsed Fallopian Tube Cancer
Drug: Birinapant
Drug: Conatumumab
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by TetraLogic Pharmaceuticals:

Primary Outcome Measures:
  • Determination of Maximum Tolerated Dose (MTD) [ Time Frame: 28 Days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Clinical response as measured by RECIST (v1.1) criteria, CA 125 (GCIG criteria) and progression-free survival (PFS). [ Time Frame: Up to 4 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: November 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Birinapant with Conatumumab Drug: 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 ); Dose Level (3a) - 17 mg/m2 (twice weekly for 4 weeks); OR Dose Level (3b) - 17 mg/m2 (twice weekly for 3 of 4 weeks)

Other Name: TL32711
Drug: Conatumumab
10 mg/kg IV on Day 1 and 15 of each cycle

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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) that are second line platinum resistant or platinum sensitive subjects who are unable to receive further platinum based therapy. Subjects 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.
  • Has a FcγRIIIa subtype of high/intermediate-affinity defined by polymorphism of V/V or V/F and not F/F amino acids in receptors. (FOR EXPANSION PHASE ONLY)

Exclusion Criteria-If subject:

  • Has cancer that progresses within 6 months of completion of first line platinum-based therapy.
  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01940172

Contacts
Contact: Susan Rippin 610-889-9900 ext 110 susan.rippin@tetralogicpharma.com

Locations
United States, California
TetraLogic research site Recruiting
Fresno, California, United States, 39720
TetraLogic Research Site Recruiting
San Luis Obispo, California, United States, 93401
United States, Massachusetts
TetraLogic Research Site Recruiting
Boston, Massachusetts, United States, 02114
United States, North Carolina
TetraLogic Research Site Recruiting
Durham, North Carolina, United States, 27710
United States, Pennsylvania
TetraLogic Research Site Recruiting
Philadelphia, Pennsylvania, United States, 19111
TetraLogic Research Site Recruiting
Philadelphia, Pennsylvania, United States, 19107
United States, Tennessee
TetraLogic Research Site Recruiting
Nashville, Tennessee, United States, 37203
United States, Texas
TetraLogic Research Facility Recruiting
Dallas, Texas, United States, 75201
Sponsors and Collaborators
TetraLogic Pharmaceuticals
  More Information

No publications provided

Responsible Party: TetraLogic Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01940172     History of Changes
Other Study ID Numbers: TL32711-POC-0090-PTL
Study First Received: September 6, 2013
Last Updated: May 30, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Ovarian Neoplasms
Peritoneal Neoplasms
Fallopian Tube Neoplasms
Neoplasms, Glandular and Epithelial
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Abdominal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Peritoneal Diseases
Fallopian Tube Diseases
Neoplasms by Histologic Type
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 11, 2014