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Home » Find Clinical Trials » Phase III Study in First-line Treatment of Patients With Metastatic Colorectal Cancer Who Are Not Candidate for Intensive Therapy. (SOLSTICE)

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

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Servier Protocol Code: CL3-95005-006 Sponsor: Institut de Recherches Internationales Servier Clinicaltrials.gov Identifier: NCT03869892 EudraCT Number: 2017-004059-22 EU Trial (CTIS) Number: 2024-516180-85-00

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How to participate in this study
If you think you are eligible for this study (see
eligibility criteria
below), you can identify the location closest to you and contact them directly. If you can’t find a location close to you, please contact Institut de Recherches Internationales Servier (I.R.I.S.)
Name: Institut de Recherches Internationales Servier, Département des études cliniques
Phone number: +33 1 55 72 60 00
The study has 190 locations

Study description

The study was done to confirm the effectiveness of a drug called S95005 (study drug), when combined with another drug in patients with metastatic colorectal cancer. Metastatic means that the cancer has spread to other parts of the body. S95005 is a combination of two drugs: trifluridine and tipiracil. It is used to treat patients with metastatic gastric or colorectal cancer when standard treatments are no longer effective. In this study, S95005 was combined with another marketed drug called bevacizumab. It was compared to a combination of capecitabine with bevacizumab. This treatment (capecitabine with bevacizumab) is recommended for patients with metastatic colorectal cancer who cannot receive strong chemotherapy, called intensive chemotherapy.

  • S95005 is a drug that blocks the growth of cancer cells.
  • Bevacizumab is a drug that blocks the blood vessels that supply the tumour. It slows the growth of the tumour.
  • Capecitabine is a drug that also blocks the growth of cancer cells.

The main goal of the study was to test if S95005 in combination with bevacizumab worked better than capecitabine with bevacizumab in patients with colorectal cancer.

Official title: An Open-label, Randomised, Phase III Study cOmparing trifLuridine/Tipiracil (S 95005) 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 (SOLSTICE Study)
Results
English (USA)
English (USA)
Conditions
Metastatic Colorectal Cancer
Interventions / Treatments
  • Trifluridine/tipiracil hydrochloride (S95005)
  • Capecitabine
  • Bevacizumab experimental
  • Bevacizumab control
Other study id numbers
  • CL3-95005-006

Eligibility Criteria

Eligible age for the study

18 years and older (Adult, Older Adult)

Sex

Male/Female

Accepts Healthy Volunteers

No

To take part in the study, participants had to:

  • Be 18 years of age or older.
  • Have been diagnosed with metastatic colorectal cancer.
  • Not have received previous treatment for colorectal cancer that had spread to other parts of the body.
  • Not have been eligible for intensive therapy.
  • Not have been eligible for surgery.

Participants could not take part in the study if:

  • They had major surgery within 4 weeks before starting the study.
  • They had previously received S95005.

How is the study designed?

Allocation
Randomized
Interventional study model
Parallel
Participant Group / Arm
Experimental: S95005 + Bevacizumab
Intervention / Treatment
Drug: Trifluridine/tipiracil hydrochloride (S95005)

Participants took the study drug orally twice daily, for 10 days, over 28 day-cycles.

Biological: Bevacizumab experimental

Participants received bevacizumab into a vein every 2 weeks.

Participant Group / Arm
Active Comparator: Capecitabine + Bevacizumab
Intervention / Treatment
Drug: Capecitabine

Participants took capecitabine orally twice daily, for 14 days, over 21 day-cycles.

Biological: Bevacizumab control

Participants received bevacizumab into a vein every 3 weeks.

Keywords

Provided by Servier
Metastatic Cancer Colorectal Colorectal Cancer Colon Rectum Metastasis
Additional Relevant MeSH Terms Glioma
Colorectal Neoplasms Neoplasm Metastasis Neoplasms