Phase Ib/II Study of Primary Chemotherapy With Paclitaxel, Gemcitabine, and Sunitinib

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

15

Participants

Timeline

Start Date

March 31, 2009

Primary Completion Date

December 31, 2009

Study Completion Date

November 30, 2010

Conditions
Breast Cancer
Interventions
DRUG

Paclitaxel,Gemcitabine,Sunitinib

"To determine the MTD, only DLT occurring during the first cycle of treatment will be considered. And MTD is defined as the dose level at which at least one-third of patients experience a DLT during their first treatment course. The recommended dose level for the subsequent phase II study is defined as the preceding dose level before the MTD is attained.~If MTD is not reached, the recommended initial dose of the phase II part will be at the dose of paclitaxel 80 mg/m2 and gemcitabine 1200 mg/m2 (days 1, 8) with sunitinib 37.5 mg qd D2-D15."

Trial Locations (1)

410-769

Center for breast cancer, National Cancer Center, Goyang

Sponsors
All Listed Sponsors
collaborator

Pfizer

INDUSTRY

collaborator

HK inno.N Corporation

INDUSTRY

lead

Jungsil Ro

OTHER_GOV

NCT01070706 - Phase Ib/II Study of Primary Chemotherapy With Paclitaxel, Gemcitabine, and Sunitinib | Biotech Hunter | Biotech Hunter