Ignite Creation Date:
2024-05-05 @ 5:09 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00398879
Status:
COMPLETED
Last Update Posted:
2018-03-14
First Post:
2006-11-06
Brief Title:
Placebo-Controlled Study of Perifosine Single Agent Chemotherapy for Metastatic Cancer Patients
Sponsor:
AEterna Zentaris
Organization:
AEterna Zentaris
Study Overview
Official Title:
A Randomized Placebo-Controlled Study of Perifosine in Combination With Single Agent Chemotherapy for Metastatic Cancer Patients
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 an exploratory phase 2 randomized placebo-controlled trial with stratification for disease and chemotherapy type The study is subsequently closed to enrollment in all arms except patients with metastatic colorectal cancer which would be randomized to either capecitabine plus perifosine or capecitabine alone
The effects of perifosine may be manifested by increased time to progression tumor regression reflected in partial or complete responses or a combination of these outcomes The primary goal of this trial is to obtain a preliminary and objective assessment of the effects of perifosine on time to progression
The effects of perifosine may be manifested by increased time to progression tumor regression reflected in partial or complete responses or a combination of these outcomes The primary goal of this trial is to obtain a preliminary and objective assessment of the effects of perifosine on time to progression
Detailed Description:
This is an exploratory phase 2 randomized placebo-controlled trial with stratification for disease and chemotherapy type If there is any evidence of improved time to progression in any tumor type with any of the drugs to be evaluated the initial study or components of the study will be expanded to increase the certainty that this is an effect of perifosine If there is compelling evidence of benefit from this study a phase 3 trial will be conducted to obtain proof of principle
Primary Study Objectives
To determine the time to tumor progression when receiving single agent chemotherapy capecitabine in combination with perifosine in comparison to patients receiving single agent chemotherapy capecitabine alone ie with placebo
Secondary Study Objectives
To determine the toxicity of single agent chemotherapy in combination with perifosine
To compare the time to progression of chemotherapy in combination with placebo to historical experience
Overall survival will also be evaluated
Primary Study Objectives
To determine the time to tumor progression when receiving single agent chemotherapy capecitabine in combination with perifosine in comparison to patients receiving single agent chemotherapy capecitabine alone ie with placebo
Secondary Study Objectives
To determine the toxicity of single agent chemotherapy in combination with perifosine
To compare the time to progression of chemotherapy in combination with placebo to historical experience
Overall survival will also be evaluated
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