Safety, Pharmacokinetics, Pharmacodynamics and Anti-tumor Activity of Sorafenib and Eribulin in Combination

PHASE1CompletedINTERVENTIONAL
Enrollment

40

Participants

Timeline

Start Date

July 31, 2012

Primary Completion Date

September 30, 2015

Study Completion Date

September 30, 2015

Conditions
Neoplasms
Interventions
DRUG

Sorafenib (Nexavar, BAY43-9006)

"Sorafenib (starting dose of 200 mg bid, level 1) administration will begin on Day 11 of Cycle 1, and will be administered twice daily continuously. If the combination is well tolerated, the dose will be escalated in new cohorts to 200 mg AM and 400 mg PM (level 2), then subsequently to 400 mg bid (level 3).~If sorafenib starting dose (level 1) is not well tolerated with eribulin, the sorafenib dose will be de-escalated to 200 mg qd (Dose Level -1) in a new cohort."

DRUG

Eribulin

Eribulin: 1.4 mg/m2 as an intravenous infusion on Days 1 and 8 of each 21-day cycle.

Trial Locations (4)

10117

Berlin

31052

Toulouse

69120

Heidelberg

79106

Freiburg im Breisgau

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

Onyx Therapeutics, Inc.

INDUSTRY

lead

Bayer

INDUSTRY