Study of TAS-102 in Patients With Metastatic Colorectal Cancer Refractory to Standard Chemotherapies
Status: Recruiting
Phase: Phase 3
Diagnosis: Gastrointestinal Malignancies, Colorectal Cancer
NCT ID: NCT01607957
(View complete trial on ClinicalTrials.gov)
DFCI Protocol ID: 12-362
The purpose of this study is to compare the efficacy and safety of TAS-102 versus placebo in patients with refractory metastatic colorectal cancer.
Conducting Institutions:
Dana-Farber Cancer Institute, Brigham and Women's Hospital, Massachusetts General Hospital
Overall PI:
Robert Mayer, MD,
Dana-Farber Cancer Institute
Site-responsible Investigators:
David P. Ryan, MD,
Massachusetts General Hospital
Contacts:
Dana-Farber Cancer Institute:
Gastrointestinal Research Line, 617-632-5960
Massachusetts General Hospital:
Cancer Trials Call Center, 877-789-6100
Eligibility Criteria
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