CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 492 enrolled
Drug / intervention
Trifluridine/Tipiracil +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04737187
NCT04737187Phase 3Completed

An Open-label, Randomized, Phase III Study Comparing Trifluridine/Tipiracil in Combination With Bevacizumab to Trifluridine/Tipiracil Monotherapy in Patients With Refractory Metastatic Colorectal Cancer (SUNLIGHT Study)

Taiho Oncology, Inc.·interventional·Posted Feb 3, 2021·Updated Sep 24, 2024

In Brief

A Phase 3 clinical trial evaluating Trifluridine/Tipiracil and Bevacizumab for Refractory Metastatic Colorectal Cancer. Completed, enrolled 492 participants across 99 sites in 14 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesAustria, Belgium, Brazil, Denmark, France, Germany, Hungary, Italy, Poland, Puerto Rico, Russia, Spain, Ukraine, United States

Timeline

Phase 3CompletedFinished
202120222023202420252026
First PostedFeb 3, 2021
Enrollment StartNov 25, 2020
Primary CompletionJul 19, 2022
Study CompletionSep 12, 2023
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 5.4 years ago

Interventions

Trifluridine/Tipiracildrug

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

Bevacizumabdrug

administered every 2 weeks (Day 1 and Day 15)