Phase I/II Trial of Sorafenib Plus Ixabepilone in HER2-Negative Metastatic Breast Cancer

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

83

Participants

Timeline

Start Date

March 31, 2009

Primary Completion Date

June 30, 2013

Study Completion Date

August 31, 2014

Conditions
Metastatic Breast Cancer
Interventions
DRUG

Sorafenib

Dose Level 1 - Sorafenib PO BID (200mg) Dose Level -1 - Sorafenib PO BID (200mg) Dose Level 1a - Sorafenib PO BID (400mg)

DRUG

Ixabepilone

Dose Level 1 - Ixabepilone IV every 21 days (40mg/m\^2) Dose Level -1 - Ixabepilone IV every 21 days (32mg/m\^2) Dose Level 1a - Ixabepilone IV every 21 days (32mg/m\^2)

Trial Locations (15)

20817

Center for Cancer and Blood Disorders, Bethesda

National Capital Clinical Research Consortium, Bethesda

29210

South Carolina Oncology Associates, Columbia

33916

Florida Cancer Specialists, Fort Myers

37023

Tennessee Oncology, PLLC, Nashville

40207

Baptist Hospital East, Louisville

45242

Oncology Hematology Care, Cincinnati

47802

Providence Medical Group, Terre Haute

RHHP/ Hope Cancer Center, Terre Haute

63044

St. Louis Cancer Care, Chesterfield

70806

Hematology Oncology Clinic, LLP, Baton Rouge

04101

Mercy Hospital, Portland

03801

Portsmouth Regional Hospital, Portsmouth

07962

Hematology-Oncology Associates of Northern NJ, Morristown

Unknown

Spartanburg Regional Medical Center, Spartanburg

Sponsors

Collaborators (2)

All Listed Sponsors
collaborator

Bayer

INDUSTRY

collaborator

Bristol-Myers Squibb

INDUSTRY

lead

SCRI Development Innovations, LLC

OTHER