SOLSTICE : 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

Male or<br/>FemaleGender Male or
Female

RecruitingStatus Recruiting

Systemic<br/>Therapy TrialTypeSystemic
Therapy Trial

ThreePhase Three

18+Age Over 18

Bowel<br/>CancersCancer LocationBowel
Cancers

Systemic therapy | Bowel (colorectum)Colon,Colorectum,Rectum

Trial Overview Read MoreRead more

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..
 

This trial is treating patients with Metastatic Colorectal Cancer.

This is a systemic treatment.

You may be able to join this trial if:

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

You may be excluded from this trial if:

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

Clinical trials have complex eligibility criteria - talk to your doctor about your interest in this trial.

Clinical Summary Read MoreRead more

Trial Identifiers

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

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

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

Commercial Sponsor

Servier

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.

Recruiting Hospitals Read MoreRead more

Peninsula & South Eastern Haematology and Oncology Group
Frankston
Mr Albert Goikman
ag@paso.com.au
03 9771 8918

Trial Overview: General information about a clinical trial. This section provides an overview of who might be able to join this trial and what type of treatment is involved.

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