Ignite Creation Date:
2025-12-24 @ 4:30 PM
Ignite Modification Date:
2025-12-26 @ 4:24 AM
Study NCT ID:
NCT00498966
Status:
COMPLETED
Last Update Posted:
2018-02-05
First Post:
2007-07-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ph II Study of Perifosine for Patients With Carcinoma of the Kidney
Sponsor:
AEterna Zentaris
Organization:
Study Overview
Official Title:
Phase II Study of Perifosine for Patients With Metastatic Carcinoma of the Kidney Who Have Progressed on a VEGF Receptor Inhibitor
Status:
COMPLETED
Status Verified Date:
2018-02
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 Phase II study. Patients with kidney carcinoma will be considered in two groups. The goals of this study are:
* To measure clinical benefit defined as tumor response or progression-free survival for more than 12 weeks in patients with metastatic carcinoma of the kidney who have failed or have progressed on a VEGF receptor inhibitor
* To evaluate the safety of perifosine in patients with metastatic carcinoma of the kidney who have failed or have progressed on a VEGF receptor inhibitor
* To measure clinical benefit defined as tumor response or progression-free survival for more than 12 weeks in patients with metastatic carcinoma of the kidney who have failed or have progressed on a VEGF receptor inhibitor
* To evaluate the safety of perifosine in patients with metastatic carcinoma of the kidney who have failed or have progressed on a VEGF receptor inhibitor
Detailed Description:
This is a Phase II study. Patients with kidney carcinoma will be considered in two groups. Patients in group A will have previously failed a VEGF receptor inhibitor but not an mTOR inhibitor, while patients in group B will have failed both a VEGF receptor inhibitor and an mTOR inhibitor. Evaluation of each group will be performed separately. The goals of this study are:
1. To measure clinical benefit defined as an objective tumor response using RESIST or progression-free survival for more than 12 weeks in patients with metastatic carcinoma of the kidney who have failed or have progressed on a VEGF receptor inhibitor
2. To evaluate the safety of perifosine in patients with metastatic carcinoma of the kidney who have failed or have progressed on a VEGF receptor inhibitor.
Treatment Phase/duration of treatment: All patients will be treated with daily perifosine at 100 mg PO daily until tumor progression (by the RECIST criteria) or unacceptable toxicity. Once radiological disease progression has been documented by the treating physician, the patient will go off study. Patients are encouraged to have two measurements for confirmation of progression.
Follow-Up Phase: All patients will be followed-up for SAEs until at least 30 days after discontinuation of perifosine. All patients who are discontinued from perifosine for any reason other than disease progression will continue to have tumor assessments until the patient has documented disease progression or has begun other therapies.
1. To measure clinical benefit defined as an objective tumor response using RESIST or progression-free survival for more than 12 weeks in patients with metastatic carcinoma of the kidney who have failed or have progressed on a VEGF receptor inhibitor
2. To evaluate the safety of perifosine in patients with metastatic carcinoma of the kidney who have failed or have progressed on a VEGF receptor inhibitor.
Treatment Phase/duration of treatment: All patients will be treated with daily perifosine at 100 mg PO daily until tumor progression (by the RECIST criteria) or unacceptable toxicity. Once radiological disease progression has been documented by the treating physician, the patient will go off study. Patients are encouraged to have two measurements for confirmation of progression.
Follow-Up Phase: All patients will be followed-up for SAEs until at least 30 days after discontinuation of perifosine. All patients who are discontinued from perifosine for any reason other than disease progression will continue to have tumor assessments until the patient has documented disease progression or has begun other therapies.
Study Oversight
Has Oversight DMC:
False
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?: