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ARIAD Announces Start of Phase 2 Clinical Study of Oral Deforolimus in Patients with Advanced Endometrial Cancer
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ARIAD Pharmaceuticals, Inc. has announced the initiation of a randomized, multi-center, Phase 2 clinical trial to evaluate the safety and efficacy of oral deforolimus, its investigational mTOR inhibitor, in patients with advanced endometrial cancer.
In collaboration with Merck & Co. Inc., 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 2 clinical trial to begin this quarter examining the safety and efficacy of oral deforolimus in patients with different solid tumors.
“We have Phase 2 data on the intravenous form of deforolimus in endometrial cancer and are pleased to now examine the potential of this drug candidate in its oral form in similar patients with this cancer,” stated Pierre F. Dodion, senior vice president and chief medical officer of ARIAD.
“There is significant unmet medical need for the effective treatment of patients with endometrial cancer, and this controlled clinical study is designed to help inform us of the potential impact of oral deforolimus on patients with this difficult-to-treat cancer,” Dodion added.
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.
ARIAD announced the initiation last month of a Phase 2 clinical trial of deforolimus in patients with advanced breast cancer.
