Combination With Gemcitabine in Advanced Pancreatic Cancer

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

90

Participants

Timeline

Start Date

January 1, 2011

Primary Completion Date

February 11, 2013

Study Completion Date

August 1, 2013

Conditions
Pancreatic Neoplasms
Interventions
DRUG

BAY86-9766+Gemcitabine

Phase I: 40 mg/day (20 mg twice daily), 60 mg/day (30 mg twice daily, 100 mg/day (50 mg bid) dependent on safety/tolerability Phase II: Recommended Phase II dose (RP2D) dependent on the results of the Phase I part of this study Route of administration: Oral, twice daily (bid) in combination with gemcitabine 1000 mg/m2 Intravenous infusion over 30 minutes weekly for seven out of eight weeks (Cycle 1); followed by 1000 mg/m2 Intravenous infusion over 30 minutes weekly for three out of four weeks (Cycle 2 and subsequent)

Trial Locations (23)

1070

Bruxelles - Brussel

1090

Bruxelles - Brussel

2650

Edegem

13353

Berlin

25124

Brescia

35033

Marburg

44892

Bochum

60126

Ancona

63003

Clermont-Ferrand

74078

Heilbronn

80045

Aurora

81377

München

01201

Pittsfield

602 00

Brno

775 20

Olomouc

0310

Oslo

Unknown

Oslo

London

15-027

Bialystok

80-952

Gdansk

02-781

Warsaw

SE1 9RT

London

WC1E 6BT

London

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Bayer

INDUSTRY