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Closed (no longer recruiting)Last updated: 20 April 2023

SOLSTICE: This phase III trial is comparing the effectiveness of two different combinations of chemotherapy and targeted therapy drugs (Trifluridine/tipiracil hydrochloride and Bevacizumab versus Capecitabine and Bevacizumab) for treating patients with metastatic colorectal cancer, who are not candidates for intensive therapy.An Open-label, Randomised, Phase III Study comparing TrifLuridine/Tipiracil (S95005) in Combination With Bevacizumab to Capecitabine in Combination With Bevacizumab in first-line Treatment of Patients With Metastatic Colorectal Cancer Who Are Not candidate for Intensive Therapy

Clinical summary

Summary

Patients eligible to participate in this study will receive Trifluridine/tipiracil hydrochloride tablets to be taken 1 hour after morning and evening meals for 10 days in week 1 and 2 of a 4 week cycle, with Bevacizumab administered by IV on Day 1 and 15 of the four week cycle. In the Capecitabine + Bevacizumab arm of the study patients will receive Capecitabine tablets to be taken on days 1 to 14 of a three week cycle, with Bevacizumab administered on day 1 of each three week cycle.

Conditions

This trial is treating patients with Metastatic Colorectal Cancer.

Cancer

Bowel Cancers Bowel

Age

People18+

Phase

III

Trial Acronym

SOLSTICE

More information

Trial Identifiers

Use the hyperlinks, where available to access additional clinical trial information.

  • NCT03869892
  • CL3-95005-006, 2017-004059-22, U1111-1206-3198

Commercial Sponsor

Servier

Scientific Title

An Open-label, Randomised, Phase III Study comparing TrifLuridine/Tipiracil (S95005) in Combination With Bevacizumab to Capecitabine in Combination With Bevacizumab in first-line Treatment of Patients With Metastatic Colorectal Cancer Who Are Not candidate for Intensive Therapy

Eligibility

Inclusion

  • You are able to swallow medication by mouth.
  • Your cancer has spread to other parts of the body.

Exclusion

  • You have had certain treatments, surgical procedures or drugs.
  • You have previously been treated (or are currently being treated) on a clinical trial.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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