A Phase II Trial of Perifosine Following Tyrosine Kinase Inhibitor Failure in Patients With Advanced Renal Cell Carcinoma
This is a single-arm phase II trial assessing the antitumor activity as measured by
progression free survival of perifosine in patients with metastatic RCC who have progressed
on sorafenib or sunitinib. A total of 48 patients will be enrolled in the trial. All
subjects will have histologically confirmed metastatic RCC with predominantly clear cell
features (≤ 50% other histologic features). Patients who have been taken off sorafenib or
sunitinib may only have been off therapy for less than three months prior to study
enrollment. Patients who remain on sorafenib or sunitinib may continue on drug at their
current dose until two weeks prior to the initiation of perifosine therapy.
The study consists of three periods: pre-treatment/screening, treatment, and follow-up. Day
1 will be defined as the first day of perifosine therapy. Patients will remain in the
treatment phase until progression or toxicity. Patients will be seen by an MD every 3 weeks
with 6 weeks defining one cycle of therapy. Tumor evaluations will occur every 6 weeks.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To estimate the progression free survival of TKI resistant patients with metastatic RCC who are treated with perifosine
Every 6 weeks
No
Daniel Cho, MD
Principal Investigator
Dana-Farber Cancer Institute
United States: Food and Drug Administration
Perifosne 228
NCT00448721
March 2007
October 2011
Name | Location |
---|---|
Dana Farber Cancer Institute | Boston, Massachusetts 02115 |
Investigative Site | Beverly Hills, California |
Investigative Site | Philadelphia, Pennsylvania |
Investigative Site | Johnson City, Tennessee 37604 |