AS703569 and Gemcitabine Combination in Advanced Malignancies

PHASE1CompletedINTERVENTIONAL
Enrollment

66

Participants

Timeline

Start Date

June 30, 2007

Primary Completion Date

July 31, 2010

Study Completion Date

February 28, 2011

Conditions
Pancreatic Cancer
Interventions
DRUG

AS703569/gemcitabine

"Gemcitabine on Days 1 and 8, AS703569 on Days 2 and 9, of a 21-day cycle. The starting dose (DL1) for AS703569 will be 10mg/m2/day. The subsequent dose levels of AS703569 will follow the dose-escalation scheme with an approximate 50% increase from DL1 to DL2, 40% from DL2 to DL3, and thereafter an approximate increase of 33% from one dose level to the next.~Gemcitabine will be administered at the dose of 1000mg/m2 once weekly during the first two weeks of each 21-day cycle."

DRUG

AS703569/gemcitabine

"AS703569 on Days 1 and 8, gemcitabine on Days 2 and 9, of a 21-day cycle. The starting dose (DL1) for AS703569 will be 10mg/m2/day. The subsequent dose levels of AS703569 will follow the dose-escalation scheme with an approximate 50% increase from DL1 to DL2, 40% from DL2 to DL3, and thereafter an approximate increase of 33% from one dose level to the next.~Gemcitabine will be administered at the dose of 1000mg/m2 once weekly during the first two weeks of each 21-day cycle."

Trial Locations (3)

1000

Institut Jules Bordet, Brussels

75679

Unite d'Oncologie Medicale Hopital COCHIN, Paris

92118

Service Inter-Hospitalier de Canderologie Bichat-Beaujon (SIHC) Hopital Beaujon, Clichy

All Listed Sponsors
lead

Merck KGaA, Darmstadt, Germany

INDUSTRY

NCT01097512 - AS703569 and Gemcitabine Combination in Advanced Malignancies | Biotech Hunter | Biotech Hunter