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A Phase 2 Evaluation of TRC105 in the Treatment of Recurrent Ovarian, Fallopian Tube, or Primary Peritoneal Carcinoma

Phase 2
18 Years
Open (Enrolling)
Recurrent Ovarian Cancer, Fallopian Tube Carcinoma, Primary Peritoneal Carcinoma

Thank you

Trial Information

A Phase 2 Evaluation of TRC105 in the Treatment of Recurrent 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,

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.

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

- 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

- 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

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

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

Outcome Time Frame:

6 months

Safety Issue:


Principal Investigator

Charles P Theuer, MD

Investigator Role:

Study Director

Investigator Affiliation:

TRACON Pharmaceuticals


United States: Food and Drug Administration

Study ID:




Start Date:

July 2011

Completion Date:

December 2012

Related Keywords:

  • Recurrent Ovarian Cancer
  • Fallopian Tube Carcinoma
  • Primary Peritoneal Carcinoma
  • Carcinoma
  • Ovarian Neoplasms
  • Fallopian Tube Neoplasms



MD Anderson Cancer CenterHouston, Texas  77030-4096
Memorial Sloan-Kettering Cancer CenterNew York, New York  10021
Palm Beach Cancer InstituteWest Palm Beach, Florida  33401
University of Alabama at BirminghamBirmingham, Alabama  35294-3300
University of California, San DiegoLa Jolla, California  92037-1709
University of Southern CaliforniaLos Angeles, California  90033
Indiana University-Bren and Melvin Simon Cancer CenterIndianapolis, Indiana  46202