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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)

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Code de protocole Servier: CL3-95005-006 Sponsor: Institut de Recherches Internationales Servier Identifiant Clinicaltrials.gov: NCT03869892 Numéro EudraCT: 2017-004059-22

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Comment participer à cette étude
Si vous pensez être éligible pour cette étude (voir
critères d'éligibilité
ci-dessous), vous pouvez identifier le site le plus proche de chez vous et le contacter directement. Si vous ne trouvez pas de site près de chez vous, veuillez contacter l'Institut de Recherches Internationales Servier (I.R.I.S.).
Nom: Institut de Recherches Internationales Servier, Département des études cliniques
Numéro de téléphone: +33 1 55 72 60 00
L'étude a 190 centres

Description de l'étude

The main purpose of this study is to demonstrate the superiority of S 95005 in combination with bevacizumab over capecitabine in combination with bevacizumab.
Titre officiel: 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)
Indications
Metastatic Colorectal Cancer
Interventions / Traitements
  • Trifluridine/tipiracil hydrochloride (S95005)
  • Capecitabine
  • Bevacizumab experimental
  • Bevacizumab control
Autres numéros d'identification
  • CL3-95005-006

Critères d'éligibilité

Age éligible pour l’étude

18 ans et plus (Adulte, Adulte plus âgé)

Sexe

Homme/Femme

Accepte les volontaires en bonne santé

Non

  • 1. Has definitive histologically confirmed adenocarcinoma of the colon or rectum (all other histological types are excluded). Primary tumour localisation must be known.
  • 2. 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).
  • 3. Patient is not a candidate for standard full dose combination chemotherapy with irinotecan or oxaliplatin
  • 4. Patient is not a candidate for curative resection of metastatic lesions.
  • 5. No previous systemic anticancer therapy for unresectable metastatic colorectal cancer.
  • 6. ECOG (Eastern Cooperative Oncology Group) performance status ≤2.
  • 7. Adequate organ function (renal, haematological, hepatic, coagulation) as described in the study protocol'

  • 8. Pregnancy, breastfeeding or possibility of becoming pregnant during the study.
  • 9. Participation in another interventional study within 4 weeks prior to the randomisation .
  • 10. Patients who have not recovered from clinically relevant non-hematologic CTCAE grade ≥ 3 toxicity of previous anticancer therapy prior to the randomisation.
  • 11. Symptomatic central nervous system metastases.
  • 12. Major surgery within 4 weeks prior to the randomisation.
  • 13. History of allergic reactions attributed to compounds of similar composition to S 95005 or any of its excipients.
  • 14. Any contraindication present in the SmPC of trifluridine/tipiracil
  • 15. Any contraindication present in the SmPC of bevacizumab
  • 16. Any contraindication present in the SmPC of capecitabine

Comment l'étude est-elle conçue ?

Allocation
Randomisé
Modèle d'étude interventionnelle
Parallèle
Groupe de participants / Bras de traitement
Expérimental: S95005 + Bevacizumab
Intervention / Traitement
Traitement: 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.
Biologique: 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.
Groupe de participants / Bras de traitement
Comparateur actif: Capecitabine + Bevacizumab
Intervention / Traitement
Traitement: Capecitabine
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.
Biologique: 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.

Mots clés

Fournis par Servier
Metastatic Cancer Colorectal Colorectal Cancer Colon Rectum Metastasis
Autres termes
Colorectal Neoplasms Neoplasm Metastasis Neoplasms