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A Randomized Phase 2 Trial of TAS-114 in Combination With S-1 Versus S-1

NCT02855125 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 128

Last updated 2024-09-19

Study results available
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Summary

This is a randomized, open-label, Phase 2 study of TAS-114 administered in combination with S-1, to investigate the efficacy, safety and tolerability of the TAS-114/S-1 regimen in patients with advanced or metastatic NSCLC.

The study will be conducted internationally in 2 regions: Asian \[Japan\] and Western \[Europe and US\]. Patients will be randomized into TAS-114/S-1 arm versus S-1 control arm in a 1:1 ratio.

Conditions

  • Advanced or Metastatic Non-small Cell Lung Cancer

Interventions

DRUG

TAS-114

TAS-114 was a modulator of 5-fluorouracil (5-FU).

DRUG

S-1

S-1 was designed to provide oral delivery of 5-FU and to reduce the rate of degradation of 5-FU in vivo.

Sponsors & Collaborators

  • Taiho Oncology, Inc.

    lead INDUSTRY

Principal Investigators

  • Taiho Central · Taiho Oncology, Inc. USA

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-08-29
Primary Completion
2017-09-30
Completion
2017-11-30
FDA Drug
Yes

Countries

  • United States
  • France
  • Italy
  • Japan
  • Poland
  • Spain

Study Locations

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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 NCT02855125 on ClinicalTrials.gov