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Study of TAS-102 or Placebo Plus BSC in Patients With Metastatic Gastric Cancer

NCT02500043 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 507

Last updated 2024-09-03

Study results available
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Summary

The purpose of this trial is to compare the effects of TAS-102 and best supportive care (BSC) with Placebo (an inactive drug) and best supportive care on metastatic gastric cancer.

Conditions

  • Refractory Metastatic Gastric Cancer

Interventions

DRUG

TAS-102

35 mg/m2/dose of TAS-102 orally, twice daily on days 1-5 and days 8-12 of each 28-day cycle.

DRUG

Placebo

35 mg/m2/dose of placebo orally, twice daily on days 1-5 and days 8-12 of each 28-day cycle.

Sponsors & Collaborators

  • Taiho Oncology, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-02-24
Primary Completion
2018-04-30
Completion
2019-12-19
FDA Drug
Yes

Countries

  • United States
  • Belarus
  • Belgium
  • Canada
  • Czechia
  • France
  • Germany
  • Ireland
  • Israel
  • Italy
  • Japan
  • Poland
  • Portugal
  • Romania
  • Russia
  • Spain
  • Turkey (Türkiye)
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02500043 on ClinicalTrials.gov