A Safety, Tolerability and Pharmacokinetic Study of TAS-114 in Combination With Capecitabine in Patients With Advanced Solid Tumors

PHASE1CompletedINTERVENTIONAL
Enrollment

60

Participants

Timeline

Start Date

November 30, 2012

Primary Completion Date

July 7, 2017

Study Completion Date

July 7, 2017

Conditions
Neoplasms
Interventions
DRUG

TAS-114/capecitabine

"Part 1 (dose-escalation phase):~Treatment cycles of TAS-114 and capecitabine orally BID for 14 days followed by 7 days rest until at least one of the discontinuation criteria are met TAS-114 dose starting at 20mg/m2/day with capecitabine dose of 760 mg/m2/day. TAS-114 doses will be escalated for each cohort up to 480mg/m2/day. If MTD is not reached by TAS-114 dose of 480mg/m2/day, the capecitabine dose will be escalated~Part 2 (expansion phase):~TAS-114 and capecitabine MTD established in Part 1 administered BID for 14 days followed by 7-day recovery period (21-day cycle)."

Trial Locations (3)

46202

IU Simon Cancer Center, Indianapolis

48201

Karmanos Cancer Institute, Detroit

90033

USC/Norris Comprehensive Cancer Center, Los Angeles

All Listed Sponsors
collaborator

Quintiles, Inc.

INDUSTRY

lead

Taiho Oncology, Inc.

INDUSTRY

NCT02025803 - A Safety, Tolerability and Pharmacokinetic Study of TAS-114 in Combination With Capecitabine in Patients With Advanced Solid Tumors | Biotech Hunter | Biotech Hunter