Phase III Study of TAS-102 plus Best Supportive Care versus Placebo plus Best Supportive Care in Patients with Colorectal Cancer
Trial Purpose and Description
This is a clinical research trial of TAS-102 an investigational drug that has not yet received FDA approval. The purpose of this trial is 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. Placebo looks like TAS-102, but does not have any of the active components. It is not a medicine. In this study, you will get either the TAS-102 or the placebo. You will not get both. This is a double-blind trial, which means that neither you nor your study doctor will know what study drug you are receiving. If you choose to participate, you will be randomly assigned (like flipping a coin) to receive either TAS-102 or placebo (an inactive substance). You will have a two to one chance of receiving the TAS-102 study drug treatment You will be "randomized" into one of the study groups described below. Randomization means that you are put into a group by chance. A computer program will place you in one of the two study groups. Neither you nor your study doctor or nurses will know which group you are randomized to. You nor your study doctor or nurses can choose the group you will be in. You will receive TAS-102 or placebo twice a day for 5 days with 2 days rest for 2 weeks, repeated every 28 days, which is one cycle. Your assigned study drug (TAS-102 or Placebo) should be taken with a glass of water within 1 hour after finishing a meal (morning and evening meal). You may continue to receive the assigned study drug (TAS-102 or Placebo) for as long as your study doctor feels you are receiving benefit, until you meet a study discontinuation condition or until you choose to discontinue.
- 18 Years and older
A patient must meet all of the following inclusion criteria to be eligible for enrollment in this study:
1. Has provided written informed consent prior to performance of any study procedure.
2. Is ≥18 years of age.
3. Has definitive histologically or cytologically confirmed adenocarcinoma of the colon or rectum.
a. KRAS status must have been determined (mutant or wild).
4. Has received at least 2 prior regimens of standard chemotherapies for metastatic colorectal cancer
and is refractory to or failing those chemotherapies.
a. Standard chemotherapy must include ALL of the following agents approved in each country:
i. Fluoropyrimidines, irinotecan and oxaliplatin
ii. An anti-VEGF monoclonal antibody (bevacizumab)
iii. At least one of the anti-EGFR monoclonal antibodies (cetuximab or panitumumab)
for KRAS wild-type patients.
b. Patients who have progressed based on imaging during or within 3 months of the last
administration of each standard chemotherapy.
c. Patients who have withdrawn from standard treatment due to unacceptable toxicity
warranting discontinuation of treatment and precluding retreatment with the same agent prior
to progression of disease will also be eligible to enter the study.
d. Patients who had received adjuvant chemotherapy and had recurrence during or within
6 months of completion of the adjuvant chemotherapy are allowed to count the adjuvant
therapy as one regimen of chemotherapy.
5. Has Eastern Cooperative Group (ECOG) performance status of 0 or 1 (see Appendix A) in the
Baseline period and on Cycle 1, Day 1.
6. Is able to take medications orally (ie, no feeding tube).
7. Has measurable or non-measurable metastatic lesion(s), as defined by RECIST version 1.1.
8. Has adequate organ function as defined by the following laboratory values obtained within 7 days
prior to study drug administration on Day 1 of Cycle 1:
a. Hemoglobin value of ≥9.0 g/dL.
b. Absolute neutrophil count of ≥1,500/mm3 (ie, ≥1.5 × 109/L by International Units [IU]).
c. Platelet count ≥100,000/mm3 (IU: ≥100 × 109/L).
d. Total serum bilirubin of ≤1.5 mg/dL (except for Grade 1 hyperbilirubinemia due solely to a
medical diagnosis of Gilbert’s syndrome).
e. Aspartate aminotransferase (AST/SGOT) and alanine aminotransferase (ALT/SGPT)
≤3.0 × upper limit of normal (ULN); if liver function abnormalities are due to underlying
liver metastasis, AST and ALT ≤5 × ULN.
f. Serum creatinine of ≤1.5 mg/dL.
9. Women of childbearing potential must have a negative pregnancy test (urine or serum) within
7 days prior to randomization. Females must agree to adequate birth control if conception is
possible during the study and up to 6 months after the discontinuation of study medication; and
males must agree to adequate birth control during the study and up to 6 months after the
discontinuation of study medication.
10. Is willing and able to comply with scheduled visits and study procedures.
- Taiho Pharma USA, Inc.
- December 2012
- Last Updated:
- Study HIC#: