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Phase III Study of Trifluridine/Tipiracil With and Without Bevacizumab in Refractory Metastatic Colorectal Cancer Patients

NCT04737187 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 492

Last updated 2024-09-24

Study results available
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Summary

This study is designed as an international, open-label, controlled two-arm, randomized phase III comparison study evaluating the efficacy and safety of trifluridine/tipiracil in combination with bevacizumab versus trifluridine/tipiracil monotherapy in patients with refractory mCRC.

Conditions

  • Refractory Metastatic Colorectal Cancer

Interventions

DRUG

Trifluridine/Tipiracil

Taken by mouth two times a day, 5 days on/2 days off, over 2 weeks, followed by a 14-day rest

DRUG

Bevacizumab

administered every 2 weeks (Day 1 and Day 15)

Sponsors & Collaborators

  • Institut de Recherches Internationales Servier

    collaborator OTHER

  • Taiho Oncology, Inc.

    lead INDUSTRY

Principal Investigators

  • Josep Tabernero, Prof · Vall d'Hebron Institute of Oncology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-11-25
Primary Completion
2022-07-19
Completion
2023-09-12
FDA Drug
Yes

Countries

  • United States
  • Austria
  • Belgium
  • Brazil
  • Denmark
  • France
  • Germany
  • Hungary
  • Italy
  • Poland
  • Puerto Rico
  • Russia
  • Spain
  • Ukraine

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 NCT04737187 on ClinicalTrials.gov