NCT00448721

A Phase II Trial of Perifosine Following Tyrosine Kinase Inhibitor (TKI) - Failure in Patients With Renal Cancer

A Phase II Trial of Perifosine Following Tyrosine Kinase Inhibitor Failure in Patients With Advanced Renal Cell Carcinoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: AEterna Zentaris · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a single-arm phase II trial of perifosine in renal cancer patients who have experienced disease progression after receiving either sorafenib or sunitinib.

Detailed description

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.

Conditions

• Renal Cell Carcinoma

Interventions

Type	Name	Description
DRUG	Perifosine	Perifosine will be administered orally at 100mg PO daily with food.

Timeline

• Start date: 2007-03-01
• Primary completion: 2010-10-01
• Completion: 2011-10-01
• First posted: 2007-03-19
• Last updated: 2018-03-01

Locations

4 sites across 1 country: United States