Efficacy and Safety Study of M200(Volociximab in Combination With Liposomal Doxorubicin)
Status:
Completed
Trial end date:
2009-10-01
Target enrollment:
Participant gender:
Summary
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. In all studies in solid
tumors, volociximab has shown a favorable safety profile when administered at 10 mg/kg q2wks
and more recently at 15 mg/kg qwk. A study of volociximab in combination with liposomal
doxorubicin in subjects with ovarian cancer or primary peritoneal cancer who have relapsed
after prior platin/taxane therapies is warranted to further evaluate the drug's efficacy and
safety. The investigators have thus far activated stage 2 of this study at 11/25 sites.
Worldwide, the study aims to enroll 150 subjects.