LBH589 in Combination With Capecitabine Plus/Minus (±) Lapatinib in Breast Cancer Patients

PHASE1CompletedINTERVENTIONAL
Enrollment

20

Participants

Timeline

Start Date

May 31, 2008

Primary Completion Date

January 31, 2009

Study Completion Date

July 31, 2011

Conditions
Breast Cancer
Interventions
DRUG

LBH589

LBH589 will be evaluated when administered twice weekly at the following possible dose levels: 20 mg, 30 mg, 45 mg, and 60 mg. Capecitabine will be paired with LBH589 and will range in dose from 825 mg/m2 to 1250 mg/m2 orally BID 14 of every 21 days. Treatment cycles will be 21 days in length. Once determined safe, 10 additional patients will be treated at the determined MTD to further assess safety.

DRUG

Capecitabine

Capecitabine will be administered orally twice daily for 14 days out of every 21 days.

DRUG

Lapatinib

Lapatinib, 1000 mg PO daily will be added to this combination.

Trial Locations (1)

37023

Tennessee Oncology, PLLC, Nashville

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Novartis

INDUSTRY

lead

SCRI Development Innovations, LLC

OTHER

NCT00632489 - LBH589 in Combination With Capecitabine Plus/Minus (±) Lapatinib in Breast Cancer Patients | Biotech Hunter | Biotech Hunter