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,
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
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Estimate the proportion of patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal carcinoma who survive progression-free for at least 6 months
6 months
No
Charles P Theuer, MD
Study Director
TRACON Pharmaceuticals
United States: Food and Drug Administration
105OC201
NCT01381861
July 2011
December 2012
Name | Location |
---|---|
MD Anderson Cancer Center | Houston, Texas 77030-4096 |
Memorial Sloan-Kettering Cancer Center | New York, New York 10021 |
Palm Beach Cancer Institute | West Palm Beach, Florida 33401 |
University of Alabama at Birmingham | Birmingham, Alabama 35294-3300 |
University of California, San Diego | La Jolla, California 92037-1709 |
University of Southern California | Los Angeles, California 90033 |
Indiana University-Bren and Melvin Simon Cancer Center | Indianapolis, Indiana 46202 |