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)
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)
The main purpose of this study is to demonstrate the superiority of S 95005 in combination with bevacizumab over capecitabine in combination with bevacizumab.
Inclusion 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'
Exclusion Criteria:
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
Buenos Aires, C1431FWO, Argentina
La Rioja, F5300COE, Argentina
Vienna, 1090, Austria
Barretos, 14784-400, Brazil
Brasília, 70200-730, Brazil
Santo André, 09060-870, Brazil
São Paulo, 01246-000, Brazil
Gabrovo, 5300, Bulgaria
Plovdiv, 4004, Bulgaria
Sofia, 1431, Bulgaria
Sofia, 1756, Bulgaria
Varna, 9003, Bulgaria
Tartu, 51014, Estonia
Paris, 75015, France
München, 81377, Germany
Budapest, 1097, Hungary
Budapest, 1122, Hungary
Naples, 80131, Italy
Padova, 35128, Italy
Rozzano (MI), 20089, Italy
Kaunas, 45434, Lithuania
Kaunas, LT-50161, Lithuania
Bialystok, 15-027, Poland
Olsztyn, 10-228, Poland
Opole, 45-061, Poland
Poznan, 61-866, Poland
Tomaszów Mazowiecki, 97-200, Poland
Coimbra, 3000-075, Portugal
Lisbon, 1649-035, Portugal
Porto, 4200-072, Portugal
Bucharest, 022328, Romania
Cluj-Napoca, 400015, Romania
Moscow, 115478, Russia
Saint Petersburg, 115478, Russia
Badalona, 08916, Spain
Córdoba, 14004, Spain
Cherkasy, 18009, Ukraine
Dnipro, 49102, Ukraine
Kyiv, 04107, Ukraine