Ovarian cancer patients who respond to initial platinum-containing systemic therapy only to experience disease progression after a treatment-free interval of less than 6 months are considered, by convention, to have platinum-resistant disease. They have a limited number of therapeutic options.
The investigational drug, EC145 is a combination of folate and a type of anti-cancer drug known as a “vinca.” Cancer cells need the vitamin folate (vitamin B‑9) to function and grow, they use a folate receptor to capture as much folate as they can out of the blood. EC145 acts as folate being grabbed by the receptors and when this occurs, vinca is released into the cancer cell and kills it.
We are conducting Phase II and Phase III randomized trials comparing EC145 and pegylated liposomal doxorubicin (PLD/doxil/caelyx) in combination, versus PLD alone, in subjects with platinum-resistant ovarian cancer.
Objective
The primary objective of the study is to compare Progression Free Survival PFS in subjects with platinum-resistant ovarian cancer who receive combination therapy with EC145 and pegylated liposomal doxorubicin (PLD) (EC145 + PLD) with that in subjects with platinum-resistant ovarian cancer who receive placebo and PLD.
This is a multicenter, centrally randomized, open-label, Phase II study of EC145 + PLD combination therapy compared with PLD alone in subjects with platinum-resistant ovarian cancer. Eligible subjects will be randomized in a 2:1 ratio to either the EC145 + PLD arm or to the PLD alone arm and will receive treatment for a minimum of 6 weeks .
We have completed the Phase II trial recruitment and the results are encouraging. Study is closed for recruitment; open for follow-up
Principal Investigator: Dr. Lucy Gilbert profile
Co-Investigators: Dr. Giovanni Artho, Dr. Srinivasan Krishnamurthy profile, Dr. Robert Lisbona, Dr. Jaroslav Prchal, Dr. Anwar Moria, Dr. Zvi Vaknin, Dr. Jorge Tapia
International, double-blinded, randomized Phase III study; EC145 in combination with PLD versus PLD with placebo. Participants will be randomized to the combination and control arms in a 2:1 ratio, respectively.
Principal Investigator: Dr. Lucy Gilbert profile
Co-Investigators: Dr. Giovanni Artho, Dr. Josee Dubus-Lissoir, Dr. Jaroslav Prchal, Dr. Jorge Tapia, Dr. Frederik Peeters
Study Coordinator: Natacha Albarracin 514-934-1934 x 31975
Funding: Endocyte Inc