Genta Incorporated has enrolled the first patient in a planned Phase IIb trial testing tesetaxel as initial chemotherapy for women with advanced or recurrent breast cancer who have not previously received chemotherapy.
Tesetaxel is the leading oral taxane in clinical development. It has been investigated in two previous Phase IIa trials against advanced Breast Cancer.
This trial will enroll women who have not previously received chemotherapy for metastatic or recurrent disease. Eligible patients who are HER2-negative (including so-called "triple negative" patients) may have received adjuvant chemotherapy and hormonal therapy.
Patients will be randomzed to one of three arms:
-- Tesetaxel administered once every 3 weeks;
-- Tesetaxel administered once weekly for 3 consecutive weeks
-- Capecitabine (Xeloda) administered twice per day for 14 consecutive days.
The trial's primary endpoint is overall response rate (ORR). Secondary endpoints include progression-free survival (PFS) and safety.
"Our preliminary results suggest that tesetaxel may compare favorably with capecitabine across a number of parameters, including response, safety, convenience, and compliance," said Dr. Loretta M. Itri, Genta's President and Chief Medical Officer in a press release. "Genta has now completed two, non-randomized, Phase 2a studies comprised of more than 80 patients. The Company has been engaged in extended discussions with regulatory authorities in the U.S. and EU regarding potential registration strategies for tesetaxel in breast cancer. We believe this new study will provide a firm basis for a Phase 3 trial design as first-line chemotherapy in this patient population."
Source: MarketWatch
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