NCT01573468

Capecitabine/Tesetaxel Versus Capecitabine/Placebo as Second-line Therapy for Gastric Cancer

A Randomized, Double-blind Study of Capecitabine Plus Tesetaxel Versus Capecitabine Plus Placebo as Second-line Therapy in Subjects With Gastric Cancer

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 580 (estimated)
• Sponsor: Genta Incorporated · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is being performed to evaluate the efficacy and safety of capecitabine in combination with tesetaxel versus capecitabine in combination with placebo as second-line treatment for patients with gastric cancer.

Conditions

• Gastric Carcinoma

Interventions

Type	Name	Description
DRUG	Tesetaxel	Tesetaxel 27 mg/m2 orally once on Day 1 of each cycle
DRUG	Placebo	Placebo orally once on Day 1 of each cycle
DRUG	Capecitabine	Capecitabine 1750 mg/m2/day orally twice daily (in 2 equally divided doses) on Days 1-14 of each cycle

Timeline

• Start date: 2012-04-01
• Primary completion: 2014-07-01
• Completion: 2014-08-01
• First posted: 2012-04-09
• Last updated: 2012-07-24

Locations

3 sites across 3 countries: United States, Germany, Taiwan