TAGS
Research type
Research Study
Full title
RANDOMIZED, DOUBLE-BLIND, PHASE 3 STUDY EVALUATING TAS-102 PLUS BEST SUPPORTIVE CARE (BSC) VERSUS PLACEBO PLUS BSC IN PATIENTS WITH METASTATIC GASTRIC CANCER REFRACTORY TO STANDARD TREATMENTS
IRAS ID
192155
Contact name
Robert E Winkler
Contact email
Sponsor organisation
Taiho Oncology, Inc.
Eudract number
2015-002683-16
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 3 months, 20 days
Research summary
Gastric cancer is the fifth most common cancer worldwide and the third most common cause of cancer-related death (after lung and liver cancer). Currently, patients with gastric cancer can be cured only when diagnosed with early stage disease in which a complete removal of the tumor can be achieved. Among patients with advanced metastatic gastric cancer who have received standard first-line therapies, the 5-year survival rate remains less than 5% and the median Overall Survival is less than 12 months. After failure of first-and second-line therapies, there are no approved or standard 3rd line treatments.
This present study is a multinational, randomized, double-blind, Phase 3 study comparing TAS-102 plus best supportive care (BSC) to placebo plus BSC in patients with metastatic gastric cancer who have received at least 2 prior regimens for advanced disease and were refractory or unable to tolerate their last prior therapy.
Approximately 500 patients will be randomized to TAS-102 plus BSC or placebo plus BSC from Japan, United States, Middle-East and Europe. Patients who had previously received at least 2 prior regimens (at least 1 cycle per regimen) for advanced disease and were refractory to or unable to tolerate their last prior therapy will be recruited into the study.
All patients will receive treatment until they meet discontinuation criteria and will be followed for survival every 4 weeks until death or until the target number of events (deaths) of the study is met, even if consent for study participation has been withdrawn after discontinuation of study treatment.
REC name
London - Hampstead Research Ethics Committee
REC reference
15/LO/2100
Date of REC Opinion
20 Jan 2016
REC opinion
Further Information Favourable Opinion