Lonafarnib in Metastatic Breast Cancer

Metastatic Breast Cancer Clinical Trial

Official title: A Phase II Study of Lonafarnib in Patients With Metastatic Breast Cancer

Status Terminated

Clinical Trial Summary

A published phase 2 study reported that lonafarnib was administered as a single agent via continuous or intermittent oral dosing to 76 women with advanced breast cancer who were previously treated with chemotherapy and/or with endocrine therapy. Objective response rates of approximately 10% were observed. This study will determine the rate of progression-free survival of patients with metastatic breast cancer who receive lonafarnib.

Clinical Trial Description

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 ;

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Neoplasms
• Metastatic Breast Cancer

• NCT number: NCT00773474
• Study type: Interventional
• Source: Hoosier Cancer Research Network
• Status: Terminated
• Phase: Phase 2
• Start date: October 2008
• Completion date: November 2010