Phase III Study in First-line Treatment of Patients With Metastatic Colorectal Cancer Who Are Not Candidate for Intensive Therapy. (SOLSTICE)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03869892|
Recruitment Status : Recruiting
First Posted : March 11, 2019
Last Update Posted : January 23, 2020
|Condition or disease||Intervention/treatment||Phase|
|Metastatic Colorectal Cancer||Drug: Trifluridine/tipiracil hydrochloride (S95005) Drug: Capecitabine Biological: Bevacizumab experimental Biological: Bevacizumab control||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||854 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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)|
|Actual Study Start Date :||March 21, 2019|
|Estimated Primary Completion Date :||September 18, 2022|
|Estimated Study Completion Date :||September 18, 2022|
|Experimental: S95005 + Bevacizumab||
Drug: Trifluridine/tipiracil hydrochloride (S95005)
Film-coated tablets of S 95005 (35 mg/m²/dose) will be administered orally twice a day (BID), within 1 hour after completion of morning and evening meals, 5 days on/2 days off, over 2 weeks, followed by a 14-day rest; This treatment cycle will be repeated every 4 weeks.
Biological: Bevacizumab experimental
Concentrate for solution for infusion, Bevacizumab (5 mg/kg, IV) administered every 2 weeks (Day 1 and Day 15). This treatment cycle will be repeated every 4 weeks.
|Active Comparator: Capecitabine + Bevacizumab||
Film-coated tablets, Capecitabine (1250 mg/m²/dose) will be administered orally BID on Days 1-14 of each cycle. This treatment cycle will be repeated every 3 weeks.
Biological: Bevacizumab control
Concentrate for solution for infusion, Bevacizumab (7.5 mg/kg, IV) will be administered on Day 1 of each cycle.This treatment cycle will be repeated every 3 weeks.
- Progression-free Survival (PFS) [ Time Frame: Up to 24 months ]Time elapsed between the randomization and the date of radiological tumour progression (according to RECIST 1.1) or death from any cause.
- Overall Survival (OS) [ Time Frame: Up to 24 months ]Time elapsed between the date of randomization and the date of death due to any cause.
- Overall response rate (ORR) [ Time Frame: Up to 24 months ]The proportion of patients with objective evidence of complete response (CR) or partial response (PR) according to RECIST 1.1 criteria and using investigator's tumour assessment.
- Disease control rate (DCR) [ Time Frame: Up to 24 months ]The proportion of patients with objective evidence of CR or PR or stable disease (SD) according to RECIST 1.1 criteria and using investigator's tumour assessment.
- Duration of response (DoR) [ Time Frame: Up to 24 months ]The time from the first documentation of response (CR or PR) to the first documentation of objective tumour progression or death due to any cause, whichever occurs first.
- Time to treatment failure (TTF) [ Time Frame: Up to 24 months ]The time from randomization to treatment discontinuation for any reason, including disease progression, treatment toxicity, patient preference, or death.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03869892
|Contact: Institut de Recherches Internationales Servier Clinical Studies Department||+33 1 55 72 43 email@example.com|
|Principal Investigator:||Thierry ANDRE, PhD||Medical Oncology departement Saint-Antoine hospital (Paris France 75012)|