A Phase 1/2, Open-Label, Adaptive, Randomized Study of Liposomal Doxorubicin With or Without M200 (Volociximab) for the Treatment of Subjects With Advanced Epithelial Ovarian Cancer or Primary Peritoneal Cancer That Have Relapsed After Prior Therapy With a Platinum/Taxane-Based Chemotherapy
This is an open-label study of liposomal doxorubicin with or without volociximab for the
treatment of subjects with advanced epithelial ovarian cancer or primary peritoneal cancer
relapsed after prior therapy with Plat/Taxane-based chemo. Volociximab is an anti-angiogenic
integrin inhibitor being developed for the treatment of solid tumors. Preclinical data with
a surrogate volociximab antibody administered as monotherapy indicate encouraging efficacy
in terms of tumor reduction and anti-angiogenic effects in mouse ovarian cancer xenograft
models. In clinical studies, volociximab has been evaluated in several solid tumor types,
including pancreatic, renal, and melanoma, with many subjects who entered the studies with
progressive disease remaining progression-free for several months.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
To evaluate the efficacy of volociximab in combination with liposomal doxorubicin in advanced epithelial ovarian cancer or primary peritoneal cancer. To evaluate the safety and tolerability of volociximab in combination with liposomal doxorubicin.
50-57 days
Yes
Mihail Obrocea, MD
Study Director
AbbVie
United States: Food and Drug Administration
206OC202
NCT00635193
July 2007
October 2009
Name | Location |
---|---|
Site Reference ID/Investigator# 75281 | Anaheim, California 92801 |
Site Reference ID/Investigator# 75275 | Redondo Beach, California 90277 |
Site Reference ID/Investigator# 75296 | Sunrise, Florida 33323 |
Site Reference ID/Investigator# 75299 | Atlanta, Georgia 30309 |
Site Reference ID/Investigator# 75300 | Savannah, Georgia 31404 |
Site Reference ID/Investigator# 75301 | Hinsdale, Illinois 60521 |
Site Reference ID/Investigator# 75274 | Baltimore, Maryland 21215 |
Site Reference ID/Investigator# 75294 | Jackson City, Missouri 65109 |
Site Reference ID/Investigator# 75279 | Oklahoma City, Oklahoma 73104 |
Site Reference ID/Investigator# 75295 | Corpus Christi, Texas 78404 |
Site Reference ID/Investigator# 75280 | Dallas, Texas 75246 |
Site Reference ID/Investigator# 75297 | Danville, Virginia 23185 |
Site Reference ID/Investigator# 75298 | Williamsburg, Virginia 23185 |
Site Reference ID/Investigator# 75278 | Green Bay, Wisconsin 54301 |