Dose-Escalation, Safety, Pharmacokinetics Study of Cabazitaxel With Gemcitabine In Patients With Solid Tumor

PHASE1/PHASE2TerminatedINTERVENTIONAL
Enrollment

19

Participants

Timeline

Start Date

November 30, 2009

Primary Completion Date

October 31, 2011

Study Completion Date

October 31, 2011

Conditions
Neoplasms, Malignant
Interventions
DRUG

cabazitaxel

"Pharmaceutical form: 60 mg/1.5 ml concentrate solution for infusion~Route of administration: Intravenous infusion over 60 minutes~Dosage:~* Study part 1: 15, 20 or 25 mg/m\^2 according to pre-defined dose escalation schedule~* Study part 2: MTD as determined in Study part 1"

DRUG

gemcitabine

"Pharmaceutical form: According to United States Package Insert (USPI)~Route of administration: Intravenous infusion over 30 minutes~Dosage:~* Study part 1: 700, 900 or 1000 mg/m\^2 according to pre-defined dose escalation schedule~* Study part 2: MTD as determined in Study part 1."

Trial Locations (4)

19111

Investigational Site Number 840004, Philadelphia

37232

Investigational Site Number 840001, Nashville

48201

Investigational Site Number 840002, Detroit

45267-0542

Investigational Site Number 840005, Cincinnati

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Sanofi

INDUSTRY