Perifosine + Sunitinib Malate for Patients With Advanced Cancers
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00399152|
Recruitment Status : Completed
First Posted : November 14, 2006
Last Update Posted : February 19, 2014
|Condition or disease||Intervention/treatment||Phase|
|Renal Cancer GIST||Drug: Perifosine Drug: Sunitinib Malate||Phase 1|
This study is a Phase I trial in two parts. In part 1, an MTD to the combination of perifosine and sunitinib malate will be determined. In some previous trials with perifosine and other biologic agents, 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 two courses of therapy, which would make them evaluable for response in a Phase II study. As a secondary endpoint, the effects of the combination of perifosine and sunitinib malate 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 6 weeks. Patients will take one 50 mg tablet of perifosine one to three times a day and sunitinib malate once a day for 4 out of 6 weeks. Patients may need anti-emetics and/or anti-diarrheals. Patients will be evaluated for progression or response at 12-week intervals.
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 at least four weeks apart.
Part 1 of this Phase I study will accrue from six to 24 patients depending on the number of dose levels evaluated. Up to six patients will be treated at each dose level. A dose limiting toxicity (DLT) will be defined as:
- Grade 3 or greater non-hematologic toxicity
- Grade 4 hematologic toxicity
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open-Label Phase I Study of the Safety of Perifosine in Combination With Sunitinib Malate for Patients With Advanced Cancers|
|Study Start Date :||October 2006|
|Actual Primary Completion Date :||December 2008|
|Actual Study Completion Date :||October 2009|
|Experimental: Perifosine+Sunitinib malate||
Perifosine Oral Dose
Drug: Sunitinib Malate
Sunitinib oral dose
- Toxicities [ Time Frame: every 6 weeks ]