Pharmacokinetics and Safety of Regorafenib (BAY73-4506) in Cancer Subjects With Severe Renal Impairment

PHASE1CompletedINTERVENTIONAL
Enrollment

24

Participants

Timeline

Start Date

June 30, 2013

Primary Completion Date

July 31, 2015

Study Completion Date

November 30, 2015

Conditions
Neoplasms
Interventions
DRUG

Regorafenib (Stivarga, BAY73-4506)

Regorafenib 160 mg o.d. will be administered as a single dose on Day 1 of Stage 1 followed by multiple dosing in an intermittent administration schedule (3 week-on/1 week-off) over 2 cycles in Stage 2 (56 days, cycle defined as 28 days)

Trial Locations (9)

63110

St Louis

80045

Aurora

90033

Los Angeles

03756

Lebanon

14263-0001

Buffalo

T6G 1Z2

Edmonton

V5Z 4E6

Vancouver

L8V 5C2

Hamilton

H2L 4M1

Montreal

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Bayer

INDUSTRY