NCT01348009

Tesetaxel Plus Capecitabine and Cisplatin in Advanced Gastric Cancer

A Phase I-II Study of Tesetaxel Plus Capecitabine and Cisplatin in Subjects With Advanced Gastric Cancer

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 63 (estimated)
• Sponsor: Genta Incorporated · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

Cisplatin, an intravenously administered platinum agent, in combination with an intravenously administered taxane and capecitabine has been shown to improve time to disease progression and overall survival in previously untreated patients with gastric cancer. This study is being performed to evaluate an orally administered taxane (tesetaxel) in combination with cisplatin and capecitabine in previously untreated patients with gastric cancer.

Conditions

• Gastric Carcinoma

Interventions

Type	Name	Description
DRUG	Tesetaxel-capecitabine-cisplatin	Phase 1: Tesetaxel orally on Day 1 of each cycle at dose of 18, 21, 24, or 27 mg/m2. If no dose-limiting toxicity, at least 3 subjects will be treated at each dose level until the maximum tolerated dose or the maximum dose of 27 mg/m2 is reached. At each tesetaxel dose level, capecitabine orally at a dose of 2000 mg/m2/day (administered in 2 equally divided doses) on Day 1-Day 14 and cisplatin intravenously at a dose of 60 mg/m2 on Day 1. Phase 2: Tesetaxel orally on Day 1 of each cycle at dose determined in Phase 1. Capecitabine orally at a dose of 2000 mg/m2/day (administered in 2 equally divided doses) on Day 1-Day 14 and cisplatin intravenously at a dose of 60 mg/m2 on Day 1.

Timeline

• Start date: 2011-05-01
• Primary completion: 2013-10-01
• Completion: 2014-01-01
• First posted: 2011-05-05
• Last updated: 2012-03-13

Locations

1 site across 1 country: South Korea