A Phase 3 Multicenter, Randomized, Open-label, Active-controlled Study of Sotorasib and Panitumumab Versus Investigator's Choice (Trifluridine and Tipiracil, or Regorafenib) for the Treatment of Previously Treated Metastatic Colorectal Cancer Subjects With Kirsten Rat Sarcoma (KRAS) p.G12C Mutation
Latest Information Update: 08 Aug 2024
At a glance
- Drugs Panitumumab (Primary) ; Sotorasib (Primary) ; Regorafenib; Tipiracil/trifluridine
- Indications Adenocarcinoma; Colorectal cancer
- Focus Registrational; Therapeutic Use
- Acronyms CodeBreak300
- Sponsors Amgen
- 06 Aug 2024 According to an Amgen media release, U.S. regulatory submission for this Phase 3 study was accepted under Priority Review with a Prescription Drug User Fee Act (PDUFA) date of October 17, 2024.
- 04 Jun 2024 Results reporting final OS data presented at the 60th Annual Meeting of the American Society of Clinical Oncology
- 28 May 2024 According to an Amgen media release, data from this study will be orally presenting at the American Society of Clinical Oncology (ASCO) 2024 Annual Meeting, taking place from May 31-June 4 in Chicago.