BERKELEY HEIGHTS, New Jersey—Genta Incorporated has announced that the company will conduct a new randomized controlled phase III trial of its lead anticancer product Genasense (oblimersen sodium) Injection in patients with advanced melanoma. The trial is designed to expand evidence for the safety and efficacy of Genasense combined with dacarbazine(Drug information on dacarbazine) for patients who have not previously been treated with chemotherapy.
The study will prospectively target patients using a biomarker—serum lactate dehydrogenase (LDH)—that identified patients who derived maximal benefit in a preceding trial of Genasense, including significant increases in overall and progression-free survival, the company said. It expects to enroll approximately 300 subjects in the trial.
