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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|ClinicalTrials.gov Identifier: NCT03869892|
Recruitment Status : Completed
First Posted : March 11, 2019
Last Update Posted : December 5, 2022
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|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)|
|Actual Enrollment :||874 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|
|Actual Primary Completion Date :||June 29, 2021|
|Actual Study Completion Date :||October 1, 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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Has definitive histologically confirmed adenocarcinoma of the colon or rectum (all other histological types are excluded). Primary tumour localisation must be known.
- 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).
- Patient is not a candidate for standard full dose combination chemotherapy with irinotecan or oxaliplatin
- Patient is not a candidate for curative resection of metastatic lesions.
- No previous systemic anticancer therapy for unresectable metastatic colorectal cancer.
- ECOG (Eastern Cooperative Oncology Group) performance status ≤2.
Adequate organ function (renal, haematological, hepatic, coagulation) as described in the study protocol'
- Pregnancy, breastfeeding or possibility of becoming pregnant during the study.
- Participation in another interventional study within 4 weeks prior to the randomisation .
- Patients who have not recovered from clinically relevant non-hematologic CTCAE grade ≥ 3 toxicity of previous anticancer therapy prior to the randomisation.
- Symptomatic central nervous system metastases.
Major surgery within 4 weeks prior to the randomisation.
Exclusion criteria related to S 95005 administration:
- History of allergic reactions attributed to compounds of similar composition to S 95005 or any of its excipients.
Any contraindication present in the SmPC of trifluridine/tipiracil
Exclusion criteria related to bevacizumab administration:
Any contraindication present in the SmPC of bevacizumab
Exclusion criteria related to capecitabine administration:
- Any contraindication present in the SmPC of capecitabine
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
|Principal Investigator:||Thierry ANDRE, PhD||Medical Oncology departement Saint-Antoine hospital (Paris France 75012)|
Study Data/Documents: Individual Participant Data Set
|Responsible Party:||Institut de Recherches Internationales Servier|
|Other Study ID Numbers:||
2017-004059-22 ( EudraCT Number )
U1111-1206-3198 ( Other Identifier: UTN )
|First Posted:||March 11, 2019 Key Record Dates|
|Last Update Posted:||December 5, 2022|
|Last Verified:||December 2022|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||Yes|
Qualified scientific and medical researchers can request access to anonymized patient-level and study-level clinical trial data.
Access can be requested for all interventional clinical studies:
In addition, access can be requested for all interventional clinical studies in patients:
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
|Time Frame:||After Marketing Authorisation in EEA or US if the study is used for the approval.|
|Access Criteria:||Researchers should register on Servier Data Portal and fill in the research proposal form. This form in four parts should be fully documented. The Research Proposal Form will not be reviewed until all mandatory fields are completed.|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
|Product Manufactured in and Exported from the U.S.:||No|
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Antineoplastic Agents, Immunological
Angiogenesis Modulating Agents
Physiological Effects of Drugs
Molecular Mechanisms of Pharmacological Action