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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.

Participating hospitals

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The Victorian Cancer Trials Link is supported by the Victorian Government through the Victorian Cancer Agency.

RAP

Cancer Council Victoria would like to acknowledge the traditional custodians of the land on which we live and work. We would also like to pay respect to the elders past and present and extend that respect to all other Aboriginal people.