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Closed (no longer recruiting)Last updated: 1 February 2024

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 Lower gastrointestinal tract

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

Trial 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

  1. Has definitive histologically confirmed adenocarcinoma of the colon or rectum (all other histological types are excluded). Primary tumour localisation must be known.
  2. RAS status based on local biological assessment of tumour biopsy must be available. If RAS status is not available at the time of randomisation, tumour biopsy must be available for RAS status determination (based on local biological assessment).
  3. Patient is not a candidate for standard full dose combination chemotherapy with irinotecan or oxaliplatin
  4. Patient is not a candidate for curative resection of metastatic lesions.
  5. No previous systemic anticancer therapy for unresectable metastatic colorectal cancer.
  6. ECOG (Eastern Cooperative Oncology Group) performance status ≤2.
  7. Adequate organ function (renal, haematological, hepatic, coagulation) as described in the study protocol'

Exclusion

  1. Pregnancy, breastfeeding or possibility of becoming pregnant during the study.
  2. Participation in another interventional study within 4 weeks prior to the randomisation .
  3. Patients who have not recovered from clinically relevant non-hematologic CTCAE grade ≥ 3 toxicity of previous anticancer therapy prior to the randomisation.
  4. Symptomatic central nervous system metastases.
  5. Major surgery within 4 weeks prior to the randomisation.

    Exclusion criteria related to S 95005 administration:

  6. History of allergic reactions attributed to compounds of similar composition to S 95005 or any of its excipients.
  7. Any contraindication present in the SmPC of trifluridine/tipiracil

    Exclusion criteria related to bevacizumab administration:

  8. Any contraindication present in the SmPC of bevacizumab

    Exclusion criteria related to capecitabine administration:

  9. Any contraindication present in the SmPC of capecitabine

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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