NCT01095120

Tesetaxel as Second-line Therapy for Patients With Advanced Gastric Cancer

A Phase II Study of Tesetaxel Administered at a Flat Dose Once Every 21 Days as Second-line Therapy to Subjects With Advanced Gastric Cancer

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 27 (estimated)
• Sponsor: Genta Incorporated · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Tesetaxel is an orally administered chemotherapy agent of the taxane class. This study is being undertaken to evaluate the efficacy and safety of tesetaxel administered as second-line therapy to patients with advanced gastric cancer.

Conditions

• Adenocarcinoma of the Stomach
• Adenocarcinoma of Esophagogastric Junction

Interventions

Type	Name	Description
DRUG	Tesetaxel	For subjects in Cohort A, a flat dose of 40 mg will be administered in Cycle 1; the dose will be adjusted based on body weight. In subsequent cycles, depending on tolerability, the Cycle 1 flat dose may be increased by 5 mg in Cycle 2, and the Cycle 2 flat dose may again be increased by 5 mg in Cycle 3. For subjects in Cohort B, a flat dose of 50 mg will be administered in Cycle 1; the dose will be adjusted based on body weight. In subsequent cycles, depending on tolerability, the dose may be increased by 10 mg in Cycle 2. For subjects in Cohort C, a dose of 27 mg/m2 will be administered in Cycle 1. In subsequent cycles, depending on tolerability, the dose will be increased to 35 mg/m2 in Cycle 2.

Timeline

• Start date: 2010-03-01
• Primary completion: 2012-09-01
• Completion: 2012-10-01
• First posted: 2010-03-29
• Last updated: 2012-03-15

Locations

4 sites across 2 countries: United States, South Korea