A Randomized, Multicenter, Phase 3 Study to Compare the Efficacy of Panitumumab in Combination With Oxaliplatin/ 5-Fluorouracil/ Leucovorin to the Efficacy of Oxaliplatin/ 5-Fluorouracil/ Leucovorin Alone in Patients With Previously Untreated Metastatic Colorectal Cancer.
Phase of Trial: Phase III
Latest Information Update: 29 Jun 2017
At a glance
- Drugs Panitumumab (Primary) ; Fluorouracil; Folinic acid; Oxaliplatin
- Indications Colorectal cancer
- Focus Registrational; Therapeutic Use
- Acronyms PRIME
- Sponsors Amgen
- 29 Jun 2017 According to an Amgen media release, the FDA has approved Vectibix (panitumumab) for the treatment of wild-type RAS metastatic colorectal cancer. The full approval for Vectibix as a treatment for patients with wild-type KRAS mCRC was based on results from the Phase 3 PRIME and ASPECCT trials. The approval of a refined indication for the treatment of patients with wild-type RAS mCRC was based on a retrospective analysis from this study and prospective, pre-defined analyses from the 0007 study.
- 29 Jun 2017 Results published in an Amgen media release.
- 25 Apr 2017 Results of retrospective analysis using data from two randomized first-line panitumumab trials (PRIME-NCT00364013 and PEAK-NCT00819780), assessing possible association between tumor sidedness and treatment efficacy, published in the Annals of Oncology.
Most Recent Events
Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History