Evaluation of TRC105 in the Treatment of Recurrent Ovarian, Fallopian Tube, or Primary Peritoneal Carcinoma
A Phase 2 Evaluation of TRC105 in the Treatment of Recurrent Ovarian, Fallopian Tube, or Primary Peritoneal Carcinoma
1 other identifier
interventional
23
1 country
7
Brief Summary
The purpose of this study is to evaluate the safety and efficacy of TRC105 in patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal carcinoma.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Jul 2011
7 active sites
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
June 21, 2011
CompletedFirst Posted
Study publicly available on registry
June 27, 2011
CompletedStudy Start
First participant enrolled
July 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2013
CompletedResults Posted
Study results publicly available
March 5, 2019
CompletedMarch 5, 2019
February 1, 2019
1.1 years
June 21, 2011
November 15, 2018
February 28, 2019
Conditions
Outcome Measures
Primary Outcomes (3)
Progression-free Survival Rate After 6 Months of Treatment on Study
Number of patients ongoing within the study who have not progressed after 6 months of treatment
6 months
Proportion of Patients Who Have Objective Tumor Response
Proportion of patients who have objective tumor response (complete or partial) by RECIST 1.1
Every 2 cycles
Adverse Events
Frequency of adverse events as assessed by NCI CTCAE (Version 4.0)
28 days
Secondary Outcomes (5)
CA-125 Response Rate
Every 2 cycles
Serum Concentrations of TRC105
Cycle 1 Day 15
TRC105 Immunogenicity
1 year
Severity of Adverse Events
28 days post last dose of TRC105
Overall Survival
2 years
Study Arms (1)
Carotuximab (TRC105) alone
EXPERIMENTALSingle arm, open label Carotuximab (TRC105) alone therapy dosed at 10 mg/kg administered intravenously over 1 to 4 hours on days 1, 8, 15 and 22 of each 28 day cycle
Interventions
Carotuximab (TRC105) 10 mg/kg weekly by intravenous administration on Days 1, 8, 15 and 22 of each 28-day cycle
Eligibility Criteria
You may qualify if:
- Recurrent epithelial ovarian, fallopian tube, or primary peritoneal carcinoma
- Measurable disease per RECIST 1.1
- At least one "target lesion" per RECIST 1.1
- Patients must have GOG Performance Status of 0 or 1
- Patients must have a life expectancy of ≥ 3 months
- Resolution of all acute toxic effects of prior therapy
- Free of active infection requiring antibiotics
- Must have had one prior platinum-based chemotherapeutic regimen for management of primary disease
- Patients could have received one additional cytotoxic regimen for management of recurrent disease
- Prior therapy directed at the malignant tumor, including hormonal and immunologic agents, must be discontinued at least three weeks prior to registration. Continuation of hormone replacement therapy is permitted.
- Adequate bone marrow function, renal function, hepatic function, neurologic function, blood coagulation parameters
- Negative serum pregnancy test and effective form of contraception for patients of childbearing potential
You may not qualify if:
- Previous treatment with TRC105
- Current treatment on another therapeutic clinical trial
- Receipt of an investigational agent within 28 days of starting study treatment
- Serious, non-healing wounds, ulcers, or bone fractures.
- Active bleeding or pathologic conditions that carry a high risk of bleeding
- Patients with tumor involving major vessels or transmural bowel wall involvement by tumor
- Use of thrombolytic or anticoagulant agents (except heparin to maintain i.v. catheters) within 10 days prior to the first dose of TRC105
- History of deep venous thrombosis (DVT)(except patients who have received adequate anticoagulation are eligible, and may continue on anticoagulation if appropriate)
- History of peptic ulcer disease or erosive gastritis within the past 6 months
- Known active viral or nonviral hepatitis
- History or evidence of CNS disease
- Clinically significant cardiovascular disease
- Known hypersensitivity to Chinese hamster ovary cell products or other recombinant human, chimeric, or humanized antibodies
- Pregnant or nursing
- Under the age of 18
- +6 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (7)
University of Alabama at Birmingham
Birmingham, Alabama, 35249, United States
University of California, San Diego
La Jolla, California, 92093, United States
University of Southern California
Los Angeles, California, 90033, United States
Palm Beach Cancer Institute
West Palm Beach, Florida, 33401, United States
Indiana University-Bren and Melvin Simon Cancer Center
Indianapolis, Indiana, 46202, United States
Memorial Sloan-Kettering Cancer Center
New York, New York, 10065, United States
MD Anderson Cancer Center
Houston, Texas, 77230, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Charles Theuer, Medical Monitor
- Organization
- TRACON Pharmaceuticals
Study Officials
- STUDY DIRECTOR
Charles P Theuer, MD
TRACON Pharmaceuticals
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 21, 2011
First Posted
June 27, 2011
Study Start
July 1, 2011
Primary Completion
August 1, 2012
Study Completion
December 1, 2013
Last Updated
March 5, 2019
Results First Posted
March 5, 2019
Record last verified: 2019-02