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early termination of phase 3 clinical trial of temsirolimus & letrozole
Termination Of Phase 3 Clinical Program With Oral Temsirolimus In Women With Metastatic Breast Cancer
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Clinical Trials
Main Category: Breast Cancer News
Article Date: 21 Mar 2006 - 0:00am (UK)
Wyeth Pharmaceuticals, a division of Wyeth (NYSE: WYE), announced today its decision to discontinue the HORIZON phase 3 clinical trial program of Wyeth's investigational drug temsirolimus oral tablets in combination with letrozole (Femara(R)), a currently approved breast cancer therapy, for first-line use in postmenopausal women with hormone-receptor positive metastatic breast cancer. This decision was based upon the recommendation of an Independent Data Monitoring Committee (IDMC) after review of data from a planned interim analysis.
The HORIZON study compared the combination of temsirolimus oral tablets and letrozole versus letrozole alone. The IDMC advised that continuation of the trial was unlikely to achieve the targeted level of efficacy for the combination therapy compared to letrozole alone. The IDMC concluded, therefore, that the risk/benefit ratio for treatment of metastatic breast cancer did not favor continuation and recommended that the trial be discontinued.
"While not the anticipated outcome, it is unfortunately not unusual for cancer drugs to work in some tumor types and not others, or even work in only some specific subpopulations of cancer patients," says Gary L. Stiles, M.D., FACC, Executive Vice President and Chief Medical Officer, Wyeth Pharmaceuticals. "We remain committed to studying temsirolimus in other cancer indications."
While the phase 3 trial for women with hormone-receptor positive metastatic breast cancer involved an oral formulation of temsirolimus, two other phase 3 clinical trials studying temsirolimus in renal cell carcinoma and mantle cell lymphoma using an intravenous formulation are continuing. After a recent review of the data, the IDMC for the renal cancer study indicated that study continue as planned.
About the IDMC and the Interim Analysis
The IDMC consists of independent experts in medical oncology, statistics and medical ethics, who are not participating in the clinical trials, whose primary responsibility is to monitor, on a periodic basis, the data emerging from a clinical trial and to provide recommendations to the sponsor on whether a study should be modified or discontinued.
About Temsirolimus
Temsirolimus is a targeted investigational drug that specifically inhibits mTOR (mammalian target of rapamycin) kinase, a protein critical for tumor growth and cell survival. Enrollment continues as planned with other ongoing clinical trials with temsirolimus in the oncology setting. In addition to Wyeth's ongoing renal cell carcinoma and mantle cell lymphoma phase 3 trials, independent investigators are evaluating temsirolimus in clinical trials in prostate cancer, and head and neck cancer. These and other early oncology trials with temsirolimus are being conducted through a cooperative research and development agreement with the National Cancer Institute. Anti-tumor activity with this agent has been previously reported in phase 1 and phase 2 studies.
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