Phase III Study in First-line Treatment of Patients With Metastatic Colorectal Cancer Who Are Not Candidate for Intensive Therapy.

Phase 3 Active not recruiting 856 enrolled Servier ADIR, a Servier Group company · collab

RandomizedParallel-groupOpen-labelTreatment

Summary

The main purpose of this study is to demonstrate the superiority of S 95005 in combination with bevacizumab over capecitabine in combination with bevacizumab.

Timeline

Start: 2019-03-21
Primary completion: 2021-06-29
Completion: 2026-12-31

Publications

Background Andre T, Falcone A, Shparyk Y, Moiseenko F, Polo-Marques E, Csoszi T, Campos-Bragagnoli A, Liposits G, Chmielowska E, Aubel P, Martin L, Fougeray R, Amellal N, Saunders MP. Trifluridine-tipiracil plus bevacizumab versus capecitabine plus bevacizumab as first-line treatment for patients with metastatic colorectal cancer ineligible for intensive therapy (SOLSTICE): a randomised, open-label phase 3 study. Lancet Gastroenterol Hepatol. 2023 Feb;8(2):133-144. doi: 10.1016/S2468-1253(22)00334-X. Epub 2022 Dec 2.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Bevacizumab	Monoclonal antibody	5 mg/kg	Intravenous
Subject	Bevacizumab	Monoclonal antibody	7.5 mg/kg	Intravenous
Comparator	Capecitabine	Small molecule	1250 mg/m2	Oral
Subject	Trifluridine/tipiracil hydrochloride	Unknown	35 mg/m2	Oral

Phase III Study in First-line Treatment of Patients With Metastatic Colorectal Cancer Who Are Not Candidate for Intensive Therapy.

Summary

Timeline

Publications

Drugs

Indications