Phase I Study of Perifosine + Sorafenib for Patients With Advanced Cancers
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||An Open-Label Phase I Study of the Safety of Perifosine in Combination With Sorafenib for Patients With Advanced Cancers|
- Toxicity [ Time Frame: Monthly ]
- Response or progression [ Time Frame: 6 months ]
|Study Start Date:||October 2006|
|Study Completion Date:||October 2011|
|Primary Completion Date:||September 2011 (Final data collection date for primary outcome measure)|
|Experimental: Perifosine + Sorafenib||
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.Drug: Sorafenib
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.
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 reduced.
- 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.