Overview

This trial is active, not recruiting.

Condition colorectal cancer
Treatments tas-102, placebo
Phase phase 3
Sponsor Taiho Oncology, Inc.
Start date June 2012
End date February 2016
Trial size 800 participants
Trial identifier NCT01607957, 2012-000109-66, TPU-TAS-102-301

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
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.
(Placebo Comparator)
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.

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
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.
Safety and tolerability evaluation will focus on adverse events and laboratory assessments
time frame: Through 30 days following last administration of study medication or until initiation of new anticancer treatment

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: 1. Has provided written informed consent 2. Has adenocarcinoma of the colon or rectum 3. Has failed at least 2 prior regimens of standard chemotherapies for metastatic colorectal cancer 4. ECOG performance status of 0 or 1 5. Is able to take medications orally 6. Has adequate organ function (bone marrow, kidney and liver) 7. 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. Exclusion Criteria: 1. Certain serious illnesses or medical condition(s) 2. Has had certain other recent treatment e.g. major surgery, anticancer therapy, extended field radiation, received investigational agent, within the specified time frames prior to study drug administration 3. Has received TAS-102 4. Has unresolved toxicity of greater than or equal to CTCAE Grade 2 attributed to any prior therapies 5. Is a pregnant or lactating female

Additional Information

Official title Randomized, Double-blind, Phase 3 Study of TAS-102 Plus Best Supportive Care (BSC) Versus Placebo Plus BSC in Patients With Metastatic Colorectal Cancer Refractory to Standard Chemotherapies
Principal investigator Robert J Mayer, MD
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 December 2015.
Information provided to ClinicalTrials.gov by Taiho Oncology, Inc..