Refametinib (BAY86-9766) in Combination With Regorafenib (Stivarga, BAY73-4506) in Patients With Advanced or Metastatic Cancer

PHASE1TerminatedINTERVENTIONAL
Enrollment

20

Participants

Timeline

Start Date

June 23, 2014

Primary Completion Date

October 23, 2015

Study Completion Date

April 5, 2016

Conditions
Neoplasms
Interventions
DRUG

Refametinib (BAY86-9766)

"Refametinib twice daily (b.i.d.) in combination with intermittent regorafenib once daily (q.d.) at the assigned dose level.~In Phase 2, the recommended Phase 2 dose (RP2D) for refametinib-regorafenib combination therapy will be used."

DRUG

Regorafenib (Stivarga, BAY73-4506)

"Refametinib twice daily (b.i.d.) in combination with intermittent regorafenib once daily (q.d.) at the assigned dose level.~In Phase 1b dose escalation, regorafenib will be administered in a 3-weeks-on / 1-week-off schedule except in one cohort, that uses regorafenib 2 weeks on / 2 weeks off regimen (dose level -2). In Phase 2, the recommended Phase 2 dose (RP2D) for refametinib-regorafenib combination therapy will be used."

Trial Locations (5)

27599

Chapel Hill

48201

Detroit

63110

St Louis

77030

Houston

06510

New Haven

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Bayer

INDUSTRY

NCT02168777 - Refametinib (BAY86-9766) in Combination With Regorafenib (Stivarga, BAY73-4506) in Patients With Advanced or Metastatic Cancer | Biotech Hunter | Biotech Hunter