Overview

This trial is active, not recruiting.

Condition colorectal cancer
Treatments tas-102, placebo
Phase phase 3
Sponsor Taiho Pharmaceutical Co., Ltd.
Start date September 2013
End date February 2016
Trial size 400 participants
Trial identifier NCT01955837, 10040090

Summary

To compare the effects of TAS-102 with placebo in patients with metastatic colorectal cancer refractory or intolerable to standard chemotherapies.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator)
Primary purpose treatment
Arm
(Experimental)
tas-102
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 is met.
(Placebo Comparator)
placebo
Placebo 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 is met.

Primary Outcomes

Measure
Overall Survival
time frame: Every 8 weeks. Survival status should be collected for up to 12 months after the last patient is randomized or until the target number of events (deaths) is met, whichever is later.

Secondary Outcomes

Measure
Progression-free survival (PFS)
time frame: Every 8 weeks. Tumor assessments will be performed until radiologic progression develops or the start of new anticancer treatment, for up to 12 months after the last patient is randomized or until the target number of events (deaths) is met.

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Has provided written informed consent - Has adenocarcinoma of the colon or rectum - Has failed at least 2 prior regimens of standard chemotherapies for metastatic colorectal cancer - ECOG performance status of 0 or 1 - Is able to take medication orally - Has adequate organ function (bone marrow, kidney and liver) - Women of childbearing potential must have a negative pregnancy test and must agree to adequate birth control if conception is possible. Males must agree to adequate birth control.

Additional Information

Official title Randomized, Double-Blind, Phase III Study of TAS-102 Versus Placebo in Asian Patients With Metastatic Colorectal Cancer Refractory or Intolerable to Standard Chemotherapies
Description This is a multinational, double-blind, two-arm, parallel, randomized Phase 3 comparison study evaluating the efficacy and safety of TAS-102 versus placebo in patients with refractory metastatic colorectal cancer. Patients will be randomly assigned (2:1) to TAS-102 (experimental arm) or placebo (control arm).
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Taiho Pharmaceutical Co., Ltd..