TPU-TAS-102-301

• Research type

  Research Study

• Full 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

• IRAS ID

  107955

• Contact name

  David Cunningham

• Sponsor organisation

  Taiho Pharma USA, Inc

• Eudract number

  2012-000109-66

• Clinicaltrials.gov Identifier

  NCT01607957

• Research summary

  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). This is a clinical research trial of TAS-102, which is the drug under investigation. 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 in patient with refractory colorectal cancer who have progressed on all other standard treatments and to find out the effects on how long patient live, how much time may pass without disease progression and the safety of the drug.

• REC name

  London - Chelsea Research Ethics Committee

• REC reference

  12/LO/1358

• Date of REC Opinion

  10 Dec 2012

• REC opinion

  Further Information Favourable Opinion