drugset / Trial / NCT00399789
A Phase 1/2 Trial of Perifosine in the Treatment of Non-Small Cell Lung Cancer
Non-randomizedSingle-groupOpen-labelTreatment
Summary
This is a study of the drug perifosine that consists of 2 parts. The first part of this study was designed to determine the highest dose of perifosine that can be administered to people every week without severe or prolonged nausea, vomiting and diarrhea. This study started with patients taking 900 mg/week and went up to 1800 mg/week. Part I of this study is completed. The MTD had been determined and incorporated in Part II. The goals in Part II are to: 1. Compare the gastrointestinal toxicity of 3 different dose-schedules and 2. Obtain preliminary information on the response rate of perifosine in non-small cell lung cancer.
Timeline
- Start
- 2004-09
- Primary completion
- 2010-12
- Completion
- 2011-12
Publications
- Results Journal of Clinical Oncology, 2006 ASCO Annual Meeting Proceedings (Post-Meeting Edition). Vol 24, No 18S (June 20 Supplement), 2006: 13063
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Perifosine | Small molecule | 200 mg | — |
| Comparator | Perifosine | Small molecule | 900 mg | — |
| Comparator | Perifosine | Small molecule | 1200 mg | — |
| Comparator | Perifosine | Small molecule | 1800 mg | — |