A Phase II Study of Lonafarnib in Patients With Metastatic Breast Cancer
OUTLINE: This is a multi-center study
Patients will be treated with lonafarnib 200 mg PO BID daily on days 1-21 of every 21-day
cycle until progression of disease, unacceptable toxicity, or investigator's discretion.
1 Cycle = 21 days of lonafarnib (plus the time required to recover from toxicity if
encountered).
ECOG Performance Status 0-1
Life Expectancy: Not Specified
Hematopoietic:
- Platelets > 100 K/mm3
- Absolute Neutrophil Count (ANC) > 1.2 K/mm3
- Hemoglobin ≥ 9 g/dl
- Serum potassium ≥ 3.3 mmol/L
Hepatic:
- Aspartate transaminase (AST) ≤ 5.0 x ULN
- Alanine transaminase (ALT) ≤ 5.0 x ULN
- Total bilirubin < 1.5 x ULN
Renal:
- Calculated creatinine clearance (using Cockcroft-Gault formula) > 45 cc/min
Cardiovascular:
- No history of Torsades de Pointes, ventricular tachycardia, ventricular fibrillation or
ventricular flutter
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To determine progression-free survival of lonafarnib in patients with metastatic breast cancer.
18 months
No
George Sledge, M.D.
Principal Investigator
Hoosier Oncology Group
United States: Food and Drug Administration
HOG BRE07-126
NCT00773474
October 2008
November 2010
Name | Location |
---|---|
Indiana University Melvin and Bren Simon Cancer Center | Indianapolis, Indiana 46202-5289 |
Arnett Cancer Care | Lafayette, Indiana 47904 |
Medical & Surgical Specialists, LLC | Galesburg, Illinois 61401 |
Cancer Care Center Of Southern Indiana | Bloomington, Indiana 47403 |
Horizon Oncology Center | Lafayette, Indiana 47905 |
Ireland Cancer Center - University Hospitals of Cleveland | Cleveland, Ohio 44106 |