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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01940172
Recruitment Status : Completed
First Posted : September 12, 2013
Last Update Posted : January 14, 2016
Sponsor:
Information provided by (Responsible Party):
TetraLogic Pharmaceuticals

Study Description
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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.


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

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 27 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : November 2013
Actual Primary Completion Date : September 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ovarian Cancer

Arms and Interventions
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Arm Intervention/treatment
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 );

Other Name: TL32711

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


Outcome Measures
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Primary Outcome Measures :
  1. Determination of Maximum Tolerated Dose (MTD) [ Time Frame: 28 Days ]

Secondary Outcome Measures :
  1. Clinical response as measured by RECIST (v1.1) criteria, CA 125 (GCIG criteria) and progression-free survival (PFS). [ Time Frame: Up to 4 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes 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) 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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01940172


Locations
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United States, California
TetraLogic research site
Fresno, California, United States, 39720
TetraLogic Research Site
San Luis Obispo, California, United States, 93401
United States, Kansas
TetraLogic Research Site
Fairway, Kansas, United States, 66205
United States, Massachusetts
TetraLogic Research Site
Boston, Massachusetts, United States, 02114
United States, North Carolina
TetraLogic Research Site
Durham, North Carolina, United States, 27710
United States, Pennsylvania
TetraLogic Research Site
Philadelphia, Pennsylvania, United States, 19107
TetraLogic Research Site
Philadelphia, Pennsylvania, United States, 19111
United States, Tennessee
TetraLogic Research Site
Nashville, Tennessee, United States, 37203
United States, Texas
TetraLogic Research Facility
Dallas, Texas, United States, 75201
Sponsors and Collaborators
TetraLogic Pharmaceuticals
More Information
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Responsible Party: TetraLogic Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01940172    
Other Study ID Numbers: TL32711-POC-0090-PTL
First Posted: September 12, 2013    Key Record Dates
Last Update Posted: January 14, 2016
Last Verified: January 2016
Additional relevant MeSH terms:
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Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Fallopian Tube Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
 Endocrine System Diseases
Gonadal Disorders
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Fallopian Tube Diseases
Conatumumab
Antineoplastic Agents, Immunological
Antineoplastic Agents