A Phase I Study of TAS-102 in Patients With Advanced Gastrointestinal Tumors.

PHASE1CompletedINTERVENTIONAL
Enrollment

65

Participants

Timeline

Start Date

September 30, 2013

Primary Completion Date

September 30, 2017

Study Completion Date

September 30, 2017

Conditions
Advanced Gastrointestinal Tumors
Interventions
DRUG

TAS-102

Escalating doses (20-35 mg/m2/dose, based on tolerability), orally, twice daily on days 1-5 of each 14-day cycle. Number of cycles: until at least one of the discontinuation criteria is met.

DRUG

CPT-11

Escalating doses (30-minute infusion of 120-180 mg/m2/dose, based on tolerability), IV (in the vein) on Day 1 of each 14-day treatment cycle. Number of cycles: until at least one of the discontinuation criteria is met.

DRUG

Bevacizumab

Dose (infusion of 5 mg/kg administered per site standard practice), IV (in the vein) on Day 1 of each 14-day treatment cycle. Number of cycles: until at least one of the discontinuation criteria is met.

Trial Locations (4)

10065

Memorial Sloan-Kettering Cancer Center, New York

37212

Vanderbilt Ingram Cancer Center, Nashville

60611

Chicago Clinical Site, Chicago

90095

Los Angeles Clinical Site, Los Angeles

All Listed Sponsors
lead

Taiho Oncology, Inc.

INDUSTRY

NCT01916447 - A Phase I Study of TAS-102 in Patients With Advanced Gastrointestinal Tumors. | Biotech Hunter | Biotech Hunter