Genta has enrolled the first patient in a new randomised clinical trial of its drug compound, Tesetaxel, used for the treatment of patients with advanced gastric cancer.
Tesetaxel is an orally absorbed taxane that has been evaluated in a broad programme of completed or ongoing Phase 2a and Phase 2b clinical trials.
The trial, known as Tesegast, is a randomised, double-blind, placebo-controlled study that is expected to enrol approximately 260 patients at around 40 sites worldwide, including the US, Western Europe and Asia.
The study will include patients with advanced gastric cancer who have a measurable disease that has progressed after initial chemotherapy, which must have included treatment with a platinum-containing drug or fluoropyrimidine.
In the all-oral chemotherapy programme, eligible patients will receive capecitabine and will also be randomly assigned to receive capsules of Tesetaxel or placebo to evaluate overall survival, overall response, progression-free survival and safety.
Genta president and chief medical officer Loretta Itri said that Tesegast builds on the company's experience in two Phase 2a studies and more than 80 patients treated with Tesetaxel as 2nd-line therapy for advanced gastric cancer.
"We are pleased with the outcome of extensive discussions with regulatory authorities in all territories that are involved with the trial," Itri added.
Jaffer Ajani, Anderson Cancer Center's medicine professor and global principal investigator for Tesegast, said intravenous taxanes are frequently used to treat patients with advanced gastric cancer, however, allergic reactions occur frequently and neutropenia is common.
"Our Phase 2 experience as 2nd-line therapy for patients with advanced gastric cancer showed that the response rate from Tesetaxel has equalled or exceeded that of Docetaxel in this patient population. I am excited to initiate the first randomised trial to observe whether the promising response rate to Tesetaxel will translate into a survival benefit for our patients," Ajani added.
Genta is a biopharmaceutical company focused on delivering new products for the treatment of patients with cancer.