Phase 3
Completed N=507
Study of TAS-102 or Placebo Plus BSC in Patients With Metastatic Gastric Cancer
Source: ClinicalTrials.gov NCT02500043 ↗Enrolled (actual)
507
Serious AEs
42.4%
Results posted
Sep 2021
Primary outcomePrimary: Overall Survival (OS) — 5.7; 3.6 months — p=0.0003
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Survival (OS) |
5.7; 3.6 | 0.0003 sig |
| SECONDARY Progression-Free Survival (PFS) |
2.0; 1.8 | — |
| SECONDARY Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAE) |
319; 151; 143; 70 | — |
Eligibility Criteria
Inclusion Criteria
- Has histologically confirmed non-resectable, metastatic gastric adenocarcinoma including adenocarcinoma of the gastroesophageal junction.
- Has previously received at least 2 prior regimens for advanced disease and were refractory to or unable to tolerate their last prior therapy.
- Has measureable or nonmeasurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria.
- Is able to take medications orally (ie, no feeding tube).
- Has an Eastern Cooperative Oncology Group performance status of 0 or 1.
- Has adequate organ function as defined by protocol defined labs.
- 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
- Has certain serious illnesses or medical conditions
- 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.
- Has previously received TAS-102.
- Has unresolved toxicity of greater than or equal to Common Terminology Criteria for Adverse Events Grade 2 attributed to any prior therapies.
- Is a pregnant or lactating female.
Data sourced from ClinicalTrials.gov (NCT02500043). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.