Phase 2 trial of tesetaxel for advanced bladder cancer

Genta announced the initiation of a Phase 2 trial of tesetaxel for the treatment of advanced bladder cancer. This study will examine the efficacy and safety of tesetaxel in patients with advanced bladder cancer who have developed progressive disease after treatment with a single 1st-line regimen. The 1st-line regimen is expected to be a combination of cisplatin plus Gemzar (gemcitabine, from Eli Lilly). The primary endpoint of this study is overall response rate. Secondary endpoints include durable response, disease control, progression-free survival, and safety. The dose for the new trial was determined from Genta’s ongoing studies in patients with advanced gastric cancer and advanced melanoma.

Tesetaxel is an orally dosed taxane capsule that has demonstrated high activity against tumors that are resistant to paclitaxel and docetaxel. It is being developed with a goal of maintaining high antitumor activity while eliminating infusion reactions, reducing neuropathy, and increasing patient convenience.

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