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Phase III study in first-line treatment of patients with metastatic colorectal cancer who are not candidate for intensive therapy. (SOLSTICE)
EU CTIS ID: 2024-516180-85-00
What this study is testing
To demonstrate the superiority of S 95005 in combination with bevacizumab over capecitabine in combination with bevacizumab in terms of progression-free survival (PFS) based on Investigator assessment in first-line treatment of patients with unrespectable metastatic colorectal cancer who are not candidate for intensive therapy.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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.
You likely can't join if
- 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.
See the full eligibility criteria
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Australia
- Ukraine
- Argentina
- United Kingdom
- Brazil
- Russian Federation
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Australia; Ukraine; Argentina; United Kingdom; Brazil; Russian Federation. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.