A Food Effect and QTc Study of Perifosine in Patients With Advanced Malignancies
18 Years
N/A
Both
Cancer
Trial Information
A Food Effect and QTc Study of Perifosine in Patients With Advanced Malignancies
Inclusion Criteria:
- Patients with advanced malignancies
- Patients with adequate organ and marrow function
Exclusion Criteria:
- Patients previously treated with perifosine
- Patients receiving any other chemotherapy, targeted agents, investigational agents or
devices within four weeks (28 days) prior to Day 1 of study treatment
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
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
Outcome Description:
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)
Outcome Time Frame:
24 days
Safety Issue:
No
Principal Investigator
Ed Cullen, PhD
Investigator Role:
Study Director
Investigator Affiliation:
Keryx / AOI Pharmaceuticals, Inc.
Authority:
United States: Food and Drug Administration
Study ID:
Protocol 147
NCT ID:
NCT01224730
Start Date:
January 2012
Completion Date:
May 2012
Related Keywords:
- Cancer
Name | Location |
|---|---|
| Austin, Texas 78705 |
