NCT01352273

MEK162 and RAF265 in Adult Patients With Advanced Solid Tumors Harboring RAS or BRAFV600E Mutations

A Phase Ib Open-label Dose Escalation Study of MEK162 and RAF265 in Adult Patients With Advanced Solid Tumors Harboring RAS or BRAFV600E Mutations

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 69 (actual)
• Sponsor: Array Biopharma, now a wholly owned subsidiary of Pfizer · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a multi- center, open-label, dose finding, Phase Ib study to be conducted in two stages: a dose escalation part to determine the maximum tolerated dose (MTD) safety and tolerability of concurrent administration of MEK162 and RAF265, followed by an expansion part to further assess the safety and preliminary anti-tumor efficacy of this oral combination within two separate patient populations: i) patients with advanced solid tumors harboring BRAFV600E mutations or ii) patients with advanced solid tumors harboring RAS mutations.

Conditions

• Advanced Solid Tumors

Interventions

Type	Name	Description
DRUG	MEK162 + RAF265

Timeline

• Start date: 2011-06-01
• Primary completion: 2013-09-01
• Completion: 2013-09-01
• First posted: 2011-05-11
• Last updated: 2020-09-30

Locations

8 sites across 5 countries: United States, Canada, Norway, Spain, Switzerland