Phase 1 Trial of the Combination of Perifosine and Gemcitabine
This is a phase 1, open-label trial of perifosine and gemcitabine in patients with
malignancies for whom single agent gemcitabine is a reasonable treatment option. All
patients will receive gemcitabine at a dose of 1000 mg/m2 on days 1 and 8 of a 21-day cycle.
Patients will receive perifosine orally at a dose of 50, 100 or 150 mg per day for the
first 14 days of the 21-day cycle. Cohorts of 3 patients will be treated with doses of 50
mg administered either once, twice or three times a day. In this study a maximum tolerated
dose (MTD) will be defined as a dose that can be given without grade 3/4 non-hematologic
toxicity in more than 1/3 patients. If 2/3 patients in any cohort encounter a grade 3/4
non-hematologic toxicity, an additional 3 patients will be added. If the dose is
intolerable for >3/6 patients then the previous level will be declared the MTD. Once an MTD
has been determined an additional 10 patients will be added at the MTD to better define the
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Robert Birch, Ph.D.
Keryx / AOI Pharmaceuticals, Inc.
United States: Institutional Review Board
|Nashville, Tennessee 37203-1632|