Tesetaxel Plus Capecitabine and Cisplatin in Advanced Gastric Cancer

PHASE1/PHASE2UnknownINTERVENTIONAL
Enrollment

63

Participants

Timeline

Start Date

May 31, 2011

Primary Completion Date

October 31, 2013

Study Completion Date

January 31, 2014

Conditions
Gastric Carcinoma
Interventions
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."

Trial Locations (1)

Unknown

RECRUITING

Yonsei Cancer Center, Yonsei University College of Medicine, Seoul

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Genta Incorporated

INDUSTRY

NCT01348009 - Tesetaxel Plus Capecitabine and Cisplatin in Advanced Gastric Cancer | Biotech Hunter | Biotech Hunter