Ignite Creation Date:
2024-05-05 @ 5:23 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00448721
Status:
COMPLETED
Last Update Posted:
2018-03-01
First Post:
2007-03-15
Brief Title:
A Phase II Trial of Perifosine Following Tyrosine Kinase Inhibitor TKI - Failure in Patients With Renal Cancer
Sponsor:
AEterna Zentaris
Organization:
AEterna Zentaris
Study Overview
Official Title:
A Phase II Trial of Perifosine Following Tyrosine Kinase Inhibitor Failure in Patients With Advanced Renal Cell Carcinoma
Status:
COMPLETED
Status Verified Date:
2012-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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-treatmentscreening 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
The study consists of three periods pre-treatmentscreening 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None