CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 154 enrolled
Drug / intervention
Trifluridine/tipiracil + bevacizumab +1 moredrug
Likely dose
Trifluridine/tipiracil + bevacizumab or capecitabine + bevacizumab (specific doses not stated in provided text)AI-extracted
Key inclusion· 8
  • Histologically or cytologically confirmed adenocarcinoma of colon or rectum
  • Metastatic disease with at least one measurable lesion
  • No prior systemic anticancer therapy for unresectable metastatic colorectal cancer
  • Not a candidate for combination chemotherapy with irinotecan or oxaliplatin, or for curative resection
Key exclusion· 4
  • Prior trifluridine/tipiracil or allergic reaction to similar compounds
  • Rare hereditary problems of galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption
  • Contraindication to bevacizumab or capecitabine
  • Pregnant or lactating female

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

Search/NCT02743221
NCT02743221Phase 2Completed

An Open-label, Randomised, Non-comparative Phase 2 Study Evaluating S 95005 (TAS-102) Plus Bevacizumab and Capecitabine Plus Bevacizumab in Patients With Previously Untreated Metastatic COlorectal Cancer Who Are Non-eligible for Intensive Therapy (TASCO1 Study).

Institut de Recherches Internationales Servier·interventional·Posted Apr 19, 2016·Updated Aug 20, 2024

In Brief

A Phase 2 clinical trial evaluating Trifluridine/tipiracil + bevacizumab and Capecitabine + bevacizumab for Metastatic Colorectal Cancer. Completed, enrolled 154 participants across 57 sites in 12 countries.

Detailed Summary

The main purpose of this study is to evaluate the progression-free survival (PFS) in patients receiving S 95005 + bevacizumab (experimental arm) or capecitabine + bevacizumab (control arm) as first-line treatment for unresectable metastatic colorectal cancer in patients non-eligible for intensive therapy.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesAustralia, Belgium, Brazil, Denmark, France, Germany, Italy, Netherlands, Poland, Russia, Spain, United Kingdom

Timeline

Phase 2CompletedFinished
2017201820192020202120222023202420252026
First PostedApr 19, 2016
Enrollment StartApr 29, 2016
Primary CompletionJan 15, 2018
Study CompletionSep 1, 2020
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 10.2 years ago

Interventions

Trifluridine/tipiracil + bevacizumabdrug

Patients were treated withTrifluridine/tipiracil + bevacizumab regimen until they met a discontinuation criterion.

Capecitabine + bevacizumabdrug

Patients were treated with capecitabine+ bevacizumab regimen until they met a discontinuation criterion.