Clinical Development

Tesetaxel has already been studied in a number of Phase 1 and Phase 2 studies, encompassing more than 280 patients. Preliminary activity has been observed in patients with advanced gastric cancer and advanced breast cancer.  In these studies, the most common side-effect was neutropenia. Genta has identified priority indications for clinical development, including gastric, prostate, breast and bladder cancer, and melanoma.

Tesetaxel is an investigational anticancer agent undergoing testing to evaluate its safety and efficacy in various forms of cancer. The safety and efficacy of tesetaxel have not been established for any use.

• Clinical Plan
• Gastric Cancer
• Advanced Melanoma
• Prostate Cancer
• Breast Cancer

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  If you would like more information on Genta products or clinical trials, please contact medinfo@genta.com.

• There is no established standard of care for the treatment of patients with advanced gastric cancer who have progressive disease after first-line therapy.  Moreover, no drugs are currently approved for this use, and advanced gastric cancer represents an important unmet medical need.  Gastric cancer is highly prevalent in East Asia, where in many countries this disease represents the first or second highest incidence for all cancer types.

  Tesetaxel has completed an initial Phase 2a study in gastric cancer.  The trial evaluated tesetaxel as 2nd-line therapy in patients who had failed a front-line fluoropyrimidine-based regimen in an open label, single arm, multi-center study.  Tesetaxel was administered orally at doses ranging from 27 mg/m² to 35 mg/m² once every 3 weeks.  Preliminary evidence of anticancer activity was observed in this trial.  As expected, neutropenia was the dose-limiting adverse reaction. Results from this phase 2 gastric cancer trial were published in the Proceedings of the American Society of Clinical Oncology. 

  • Evans T, et al.:  A phase II study of DJ-927 as second-line therapy in patients (pts) with advanced gastric cancer (GC) who have failed a 5-FU non taxane based regimen.  Proc Am Soc Clin Oncol 24:18S, 2006 

  The clinical plan includes the conduct of a confirmatory Phase 2b study in 2nd-line gastric cancer.  The two-stage design open-label trial enrolls patients with advanced gastric cancer who have progressed after receiving a single regimen of chemotherapy.

  Tesetaxel has received Orphan Drug designation in the U.S. for advanced gastric cancer.

  The safety and efficacy of tesetaxel have not been established for any use.

• Genta has more than 10 years of clinical research experience with advanced melanoma.  Standard taxanes have been increasingly used for the treatment of advanced melanoma, but no drugs in this class are currently approved for this use.  Building on our experience, we are studying tesetaxel in patients with advanced melanoma who have progressed after standard first-line treatment.

  Genta is currently conducting a Phase 2 trial in patients with advanced melanoma who have a normal serum lactate dehydrogenase (LDH) and have progressed after one chemotherapy regimen.

  Tesetaxel has received Orphan Drug designation in the U.S. for advanced melanoma.

  The safety and efficacy of tesetaxel have not been established for any use.
  

• One standard taxane (docetaxel) is established as 1st-line therapy in advanced castrate-resistant prostate cancer (CRPC). Genta plans to explore the activity of tesetaxel in CRPC in order to evaluate its utility as a potentially improved method of treatment.

  The safety and efficacy of tesetaxel have not been established for any use.

• An initial Phase 2a study of tesetaxel in patients who progressed after treatment with an anthracycline-containing regimen in an open-label multi-center trial has been completed.  In these 2nd and 3rd-line patients, tesetaxel was administered at doses ranging from 27 mg/m² to 35 mg/m² orally once every 3 weeks.  Preliminary anticancer activity was observed, and neutropenia was the limiting adverse effect. Genta is currently evaluating the design of new studies that can explore the potential utility of tesetaxel in patients with breast cancer.

  The safety and efficacy of tesetaxel have not been established for any use.