In collaboration with Merck & Co, deforolimus is currently being studied in multiple clinical trials, both alone and in combination with other therapies, in patients with several different types of cancer. Under terms of the agreement, Ariad will receive a $2.5 million milestone payment from Merck upon treating the first patient in this clinical study.
The clinical trial will compare single-agent oral deforolimus to progestin in patients with metastatic or recurrent endometrial cancer following first line chemotherapy. The primary endpoint for the study is progression-free survival.
Overall survival and response rate will be evaluated as secondary endpoints. This is the second Phase II clinical trial to begin this quarter examining the safety and efficacy of oral deforolimus in patients with different solid tumors.
The clinical trial will enroll 150 patients at approximately 50 sites including medical centers in North America, Europe, Asia and Australia. Patients will be randomized (1:1) to oral deforolimus or progestin, a commonly accepted treatment in patients with endometrial cancer. Enrollment in the trial is expected to be completed by the second half of 2009.
Harvey Berger, chairman and CEO of Ariad, said: “The start of this study is another important milestone for deforolimus and for the joint development program with Merck. We are committed to completing these clinical trials as quickly as possible facilitating the potential development of deforolimus in multiple cancer indications.”