Evaluation of TRC105 in the Treatment of Recurrent Ovarian, Fallopian Tube, or Primary Peritoneal Carcinoma

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Tracon Pharmaceuticals Inc.
ClinicalTrials.gov Identifier:
NCT01381861
First received: June 21, 2011
Last updated: December 3, 2013
Last verified: December 2013

June 21, 2011
December 3, 2013
July 2011
August 2012   (final data collection date for primary outcome measure)
  • Estimate the proportion of patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal carcinoma who survive progression-free for at least 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Estimate the proportion of patients who have objective tumor response (complete or partial) by RECIST 1.1 criteria [ Time Frame: Every 2 cycles ] [ Designated as safety issue: No ]
  • Determine the frequency of adverse events as assessed by NCI CTCAE (Version 4.0) [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01381861 on ClinicalTrials.gov Archive Site
  • Estimate the CA-125 response rate by GCIG criteria [ Time Frame: Every 2 cycles ] [ Designated as safety issue: No ]
  • To estimate median duration of progression-free survival [ Time Frame: 6 - 12 months ] [ Designated as safety issue: No ]
  • Measure peak and trough serum concentrations of TRC105 with ELISA and correlate with response, PFS, survival, adverse events and baseline characteristics [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Evaluate TRC105 Immunogenicity [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Determine the severity of adverse events as assessed by NCI CTCAE [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
  • To estimate median duration of overall survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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

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.

Angiogenesis plays a central role in the progression of epithelial ovarian cancer. In mouse models, VEGF-inhibitors diminish ovarian tumor growth, metastasis and malignant ascites formation. Independent Phase 2 trials have demonstrated single-agent activity for bevacizumab in recurrent ovarian cancer, and randomized controlled Phase 3 trials are ongoing in the first-line setting (GOG 0218 and ICON-7) and for recurrent disease (GOG 0213, OCEANS).

TRC105 is an antibody to CD105, an important non-VEGF angiogenic target on vascular endothelial cells. TRC105 inhibits angiogenesis, tumor growth and metastases in preclinical models. In a Phase 1 study of advanced solid tumors, TRC105 therapy caused a global reduction in angiogenic biomarkers and reduced tumor burden at doses that were well-tolerated. We hypothesize that TRC105 will have single-agent activity in recurrent ovarian cancer. By targeting a non-VEGF pathway, TRC105 has the potential to complement VEGF inhibitors which could represent a major advance in ovarian cancer therapy.

Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Recurrent Ovarian Cancer
  • Fallopian Tube Carcinoma
  • Primary Peritoneal Carcinoma
Biological: Chimeric monoclonal antibody (TRC105) to CD105
10 mg/kg weekly by intravenous administration on Days 1, 8, 15 and 22 of each 28-day cycle
Other Names:
  • TRC105
  • NSC#754227
Experimental: TRC105
Intervention: Biological: Chimeric monoclonal antibody (TRC105) to CD105
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
23
December 2013
August 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • Patients with or with anticipation of invasive procedures including major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to treatment with TRC105
  • History of other invasive malignancies, except non-melanoma skin cancer and other cancers that have been treated with no evidence of disease within the last 3 years
  • History of primary endometrial cancer diagnosed within the last 5 years, unless all of the following conditions are met: Stage not greater than I-B; no more than superficial myometrial invasion, without vascular or lymphatic invasion; no poorly differentiated subtypes, including papillary serous, clear cell or other FIGO Grade 3 lesions
  • Patients who have received prior chemotherapy for any abdominal or pelvic tumor OTHER THAN for the treatment of ovarian, fallopian tube, or primary peritoneal cancer within the last five years are excluded. Patients may have received prior adjuvant chemotherapy for localized breast cancer, provided that it was completed > 3 years prior to registration, and patient remains free of recurrent or metastatic disease
  • Prior radiotherapy to any portion of the abdominal cavity or pelvis
  • Patients with clinical symptoms or signs of gastrointestinal obstruction and who require parenteral hydration and/or nutrition
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01381861
105OC201
No
Tracon Pharmaceuticals Inc.
Tracon Pharmaceuticals Inc.
Not Provided
Study Director: Charles P Theuer, MD TRACON Pharmaceuticals
Tracon Pharmaceuticals Inc.
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP