drugset / Trial / NCT00081510
Anastrozole Plus Lonafarnib (SCH 66336) or Plus Placebo for the Treatment of Advanced Breast Cancer (P03480)
RandomizedParallel-groupTriple-blindTreatment
Summary
Primary Objective(s): * To compare the activity (progression-free survival \[PFS\]) of anastrozole in combination with lonafarnib to that of anastrozole in combination with placebo in subjects with hormone-sensitive ADVANCED breast cancer. Secondary Objective(s): * To determine the effects of anastrozole in combination with lonafarnib on objective response, duration of response, overall survival, and safety in subjects with advanced breast cancer. To assess the exposure and pharmacokinetics of lonafarnib and anastrozole in the subject population.
Timeline
- Start
- 2003-12
- Primary completion
- 2009-05
- Completion
- 2009-05
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Anastrozole | Other / unclassified | 1 mg | Oral |
| Subject | Lonafarnib | Small molecule | 200 mg | Oral |