drugset / Trial / NCT00399126

Phase I Trial of Paclitaxel With Perifosine

NCT00399126

Phase 1 Completed 24 enrolled AEterna Zentaris
Non-randomizedSingle-groupOpen-labelTreatment

Summary

This is a study of the drug perifosine given in combination with paclitaxel. Perifosine is an oral anti-cancer agent that has been used in more than 140 people. Paclitaxel is a standard chemotherapy agent used in many types of cancer. This study is designed to determine the highest dose of perifosine that can be administered to people every day while they are receiving paclitaxel in one of two regimens, without severe or prolonged nausea, vomiting and diarrhea. This study starts with patients taking 50 mg/day and goes up to 150 mg/day.

Timeline

Start
2004-11
Primary completion
2009-01
Completion
2011-10

Publications

  • Results 1) Journal of Clinical Oncology, 2006 ASCO Annual Meeting Proceedings (Post-Meeting Edition). Vol 24, No 18S (June 20 Supplement), 2006: 13134 2) Journal of Clinical Oncology, 2006 ASCO Annual Meeting Proceedings (Post-Meeting Edition). Vol 24, No 18S (June 20 Supplement), 2006: 13117

Drugs

EvaluationDrugModalityDoseRoute
Subject Paclitaxel Small molecule 80 mg/m2 Intravenous
Subject Paclitaxel Small molecule 175 mg/m2 Intravenous
Subject Perifosine Small molecule 50 mg Oral

Indications