An Open-Label Phase I Study of the Safety of Perifosine in Combination With Sorafenib for Patients With Advanced Cancers
This study is a Phase I trial in two parts. In part 1, an MTD to the combination of
perifosine and sorafenib will be determined. The experience with perifosine and other
biologic agents has been that doses determined in Phase I studies are not as well tolerated
in larger groups of patients when response is an endpoint. Thus in part 2, with the MTD as
a starting point, a group of patients will be accrued with the goal of ensuring that they
will be able to tolerate at least three courses of therapy, which would make them evaluable
for response in a Phase II study. The effects of the combination of perifosine and
sorafenib will be evaluated for response rate and time to progression. The pharmacokinetics
of the combination of the study drugs will be measured.
For the purposes of this study, one cycle of therapy will be defined as 4 weeks. Patients
will take perifosine one to three times a day and will also receive sorafenib one to two
times a day. Patients may need anti-emetics and/or anti-diarrheals.
- Patients who experience toxicity may continue on treatment with doses delayed or
- All patients should continue therapy unless disease progression is documented on two
occasions four weeks apart
All patients should be evaluated at each visit for adverse events. Patients will keep a
diary documenting compliance with study drug, toxicities and any symptoms of hand/foot
syndrome including numbness, tingling, redness or presence of sores, and any symptoms of
hypertension. Patients will be evaluated for progression or response at 12-week intervals.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
United States: Food and Drug Administration