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Study of TAS-102 in Patients With Metastatic Colorectal Cancer Refractory to Standard Chemotherapies

NCT01607957 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 800

Last updated 2024-09-19

Study results available
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Summary

The purpose of this study is to compare the efficacy and safety of TAS-102 versus placebo in patients with refractory metastatic colorectal cancer.

Conditions

Interventions

DRUG

TAS-102

35 mg/m2/dose, orally, twice daily on days 1-5 and 8-12 of each 28-day cycle. Number of cycles: until at least one of the discontinuation criteria are met.

DRUG

Placebo

Placebo tablets, orally, twice daily on days 1-5 and 8-12 of each 28-day cycle. Number of cycles: until at least one of the discontinuation criteria are met.

Sponsors & Collaborators

  • Taiho Oncology, Inc.

    lead INDUSTRY

Principal Investigators

  • From - Boston, MA · Dana-Farber Cancer Institute

  • From - Leuven, Belgium · University Hospital, Gasthuisberg

  • From - Kashiwa, Chiba Japan · National Cancer Center Hospital East

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-06-17
Primary Completion
2014-01-31
Completion
2016-05-23

Countries

  • United States
  • Australia
  • Austria
  • Belgium
  • Czechia
  • France
  • Germany
  • Ireland
  • Italy
  • Japan
  • Spain
  • Sweden
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01607957 on ClinicalTrials.gov