A Food Effect and QTc Study of Perifosine in Patients With Advanced Malignancies
This is a Phase I study which will analyze any food-drug effects as well as QTc effects of perifosine. Safety and efficacy will also be evaluated.
Patients who complete the first 24 days on single agent perifosine may have the opportunity to 1) continue on single agent perifosine; 2) switch to the combination of capecitabine + perifosine; or 3) switch to the combination of sorafenib + perifosine.
|Study Design:||Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Food Effect and QTc Study of Perifosine in Patients With Advanced Malignancies|
- To evaluate the effects of food on the PK profile and bioavailability of perifosine, and to evaluate the effects of perifosine treatment on ECG parameters [ Time Frame: 24 days ] [ Designated as safety issue: No ]
- To assess the Pharmacokinetic profile of perifosine when given to patients under fed and fasted conditions
- To evaluate changes in other ECG parameters associated with perifosine treatment (ventricular rate, PR interval, QRS interval, QT interval)
- To evaluate the safety and efficacy of perifosine when given to patients with advanced malignancies [ Time Frame: Up to 6 months ] [ Designated as safety issue: No ]
- To evaluate the safety profile (adverse events) and efficacy (response rate, and time to progression) of all study patients treated with perifosine.
- After Day 24, to evaluate the safety profile (adverse events) and efficacy (response rate and time to progression) of all study patients who remain on single agent perifosine, switch to the combination of capecitabine + perifosine or switch to the combination of sorafenib + perifosine.
|Study Start Date:||January 2012|
|Estimated Study Completion Date:||May 2012|
|Estimated Primary Completion Date:||May 2012 (Final data collection date for primary outcome measure)|
Experimental: Perifosine 100 mg
Perifosine 100 mg orally daily under Fed and Fasted conditions
100 mg daily
|United States, Texas|
|Dallas, Texas, United States, 75230|
|Houston, Texas, United States, 77030|
|Study Director:||Ed Cullen, PhD||Keryx / AOI Pharmaceuticals, Inc.|