The FLOTILLA Study: Providing Continued Access to The Study Medicines Encorafenib and Binimetinib for Participants in Prior Clinical Trials

Studien-Informationen

Ein-/Ausschlusskriterien

Studien-Rationale

Studien-Arme

• Experimental: Binimetinib only treatment
  For those participants receiving binimetinib treatment in parent studies
• Experimental: Encorafenib only Treatment
  For those participants receiving encorafenib only treatment in parent studies
• Experimental: Encorafenib & Binimetinib Treatment
  For those participants receiving encorafenib & binimetinib treatment in parent studies.
• Experimental: Treatment of Encorafenib & Binimetinib & Ribociclib
  For those participants receiving treatment of encorafenib & binimetinib & ribociclib in parent studies
• Experimental: Treatment of Encorafenib & Binimetinib & Cetuximab
  For those participants receiving treatment of encorafenib & binimetinib & cetuximab in parent studies

Geprüfte Regime

• Binimetinib only treatment:
  Binimetinib will be administered at the same dose level (15 mg to 45 mg) as that received in the Parent Studies C4211001 and C4211003 with water irrespective of food, continuously, starting on Day 1.
• Encorafenib only Treatment:
  Encorafenib will be self-administered at the same dose level as that received in the C4221010 Parent Study.
• Encorafenib & Binimetinib Treatment:
  Encorafenib will be administered on a 300 mg QD schedule and binimetinib will be administered on a 45 mg BID schedule, both orally as a flat fixed dose. Cetuximab will be administered at either 400 mg/m2 or 500 mg/m2 IV every 2 weeks on Days 1 and 15 of every cycle.
• Treatment of Encorafenib & Binimetinib & Ribociclib:
  Encorafenib capsule and ribociclib capsules or tablets will be co-administered orally QD with binimetinib tablets BID. The study drugs will be administered as a flat-fixed dose, and not by body weight or body surface area.
• Treatment of Encorafenib & Binimetinib & Cetuximab:
  Encorafenib will be administered on a 300 mg QD schedule and binimetinib will be administered on a 45 mg BID schedule, both orally as a flat fixed dose. Cetuximab will be administered at either 400 mg/m2 or 500 mg/m2 IV every 2 weeks on Days 1 and 15 of every cycle.

Quelle: ClinicalTrials.gov