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

Taiho Pharma

Status and phase: Completed; Phase 3

Conditions: Refractory Metastatic Gastric Cancer

Treatments: Drug: Placebo; Drug: TAS-102

Study type: Interventional

Funder types: Industry

Identifiers

NCT02500043

TO-TAS-102-302

2015-002683-16 (EudraCT Number)

Details and patient eligibility

About

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.

Full description

This is a multinational, double-blind, two-arm, parallel, randomized, Phase 3 study evaluating the efficacy and safety of TAS-102 plus BSC versus placebo plus BSC in participants with metastatic gastric cancer who have previously received at least 2 prior regimens for advanced disease. Eligible participants will be centrally randomized (2:1) to TAS-102 + BSC (experimental arm) or placebo + BSC (control arm).

Enrollment: 507 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Has histologically confirmed non-resectable, metastatic gastric adenocarcinoma including adenocarcinoma of the gastroesophageal junction.
2. Has previously received at least 2 prior regimens for advanced disease and were refractory to or unable to tolerate their last prior therapy.
3. Has measureable or nonmeasurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria.
4. Is able to take medications orally (ie, no feeding tube).
5. Has an Eastern Cooperative Oncology Group performance status of 0 or 1.
6. Has adequate organ function as defined by protocol defined labs.
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. Has certain serious illnesses or medical conditions
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 previously received TAS-102.
4. Has unresolved toxicity of greater than or equal to Common Terminology Criteria for Adverse Events Grade 2 attributed to any prior therapies.
5. Is a pregnant or lactating female.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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507 participants in 2 patient groups

TAS-102+BSC

Experimental group

Description:

Participants received 35 milligrams per meter square (mg/m\^2) of TAS-102 tablets orally twice daily (BID) for 5 days per week (i.e., from Days 1 to 5 and Days 8 to 12) for 2 weeks followed by 14 days rest in each 28-day cycle along with BSC until a discontinuation criterion (participant withdrawal, disease progression, irreversible treatment-related Grade 4 non-hematologic event, physician's decision, pregnancy or death) was met.

Treatment:

Drug: TAS-102

Placebo+BSC

Experimental group

Description:

Participants received 35 mg/m\^2 of matching placebo for TAS-102 tablets orally BID for 5 days per week (i.e., from Days 1 to 5 and Days 8 to 12) for 2 weeks followed by 14 days rest in each 28-day cycle along with BSC until discontinuation criterion (participant withdrawal, disease progression, irreversible treatment-related Grade 4 non-hematologic event, physician's decision, pregnancy or death) was met.

Treatment:

Drug: Placebo