This is a clinical research trial to compare the effects, good and/or bad of TAS-102 and best supportive care with placebo (an inactive drug) and best supportive care on you and your refractory colorectal cancer to find out the effects on how long you may live, how much time may pass without disease progression and the safety of TAS-102.

Phase 1

• Conditions: Refractory metastatic colorectal cancer; MedDRA version: 17.1Level: PTClassification code 10052358Term: Colorectal cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2012-000109-66-BE
• Lead Sponsor: Taiho Oncology, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-07-30
• Last Update Posted: 8 August 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 800

Inclusion Criteria

A patient must meet all of the following inclusion criteria to be eligible for enrollment in this study:
-Has provided written informed consent
-Has histologically or cytologically confirmed adenocarcinoma of the colon or rectum.
-Has received at least 2 prior regimens of standard chemotherapies for metastatic colorectal cancer and is refractory to or failing those chemotherapies.
-ECOG performance status of 0 or 1
-Is able to take medications 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
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 440
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 360

Exclusion Criteria

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 (excluding anemia, alopecia, skin
pigmentation, and platinum-induced neurotoxicity).
5. Is a pregnant or lactating female.
Other protocol-defined inclusion/exclusion criteria may apply.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified