A Phase I Study of Perifosine + Capecitabine for Patients With Advanced Colon Cancer
This study is a Phase I trial. A total of 3 ‐ 9 patients will be enrolled. Three patients
will initially be enrolled. There will be no dose escalation in this study as only one dose
for perifosine (50 mg) in combination with one dose of capecitabine (1000 mg/m2 BID) will be
evaluated. The maximum tolerated dose (MTD) is defined in which fewer than 33% of patients
experienced DLT attributable to the study drug(s), when at least six patients have been
treated at that dose and are evaluable for toxicity. Pharmacokinetic (PK) data will also be
evaluated from all enrolled patients.
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Safety. Determination of maximum tolerated dose.
Every 3 weeks
Johanna Bendell,, MD
Sarah Cannon Research Institute
United States: Food and Drug Administration