Ignite Creation Date:
2025-12-24 @ 10:17 PM
Ignite Modification Date:
2025-12-25 @ 7:51 PM
Study NCT ID:
NCT00479635
Status:
TERMINATED
Last Update Posted:
2014-01-22
First Post:
2007-05-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Phase II Trial of TPI 287 in Patients With Metastatic Prostate Cancer
Sponsor:
Cortice Biosciences, Inc.
Organization:
Study Overview
Official Title:
A Phase II Trial of TPI 287 in Patients With Metastatic Prostate Cancer Who Have Progressive Neoplastic Disease Following Treatment With One Prior Taxane Regimen
Status:
TERMINATED
Status Verified Date:
2014-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Sponsor could no longer support; enrollment stopped August 2008.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The primary objective of the study is to determine the response rate to TPI 287 in patients with metastatic, hormone-refractory prostate cancer who have had one prior taxane regimen.
Detailed Description:
This is an open-label, multi-center, 2-stage Simon design, Phase 2 study of TPI 287 in patients with metastatic, hormone-refractory prostate cancer. All patients must have received prior taxane therapy. Up to 80 patients will be enrolled and stratified based on duration of cumulative exposure to a single prior taxane regimen. A single taxane regimen is considered to he a taxane or taxane containing therapy administered on a defined schedule with no more than 2 months' interruption between treatments, and total exposure will be assessed by the number of months on that schedule.
One stratum (up to 40 patients) will consist of patients who have had over 3 months (up to a maximum of 10 months) exposure to a taxane regimen, who then have documented progression of disease (initially taxane sensitive). The second stratum (up to 40 patients) will consist of patients considered primarily resistant to taxanes who have had documented progressive disease as best response after exposure to a single taxane regimen for less than or equal to 3 months. Patients may have received prior hormonal therapy and/or bisphosphonates and may continue on these therapies.
In the first stage of the trial, 22 patients in each stratum will be treated with TPI 287 intravenously every 21 days. If 1 or fewer patients in either stratum demonstrate a response in this first stage, the trial will be discontinued for that stratum. Otherwise, an additional 18 patients in the stratum showing 2 or more responses will be enrolled in the second stage of the study. If 4 or fewer patients demonstrate a response in the total study population in either stratum from stages 1 and 2, then the drug will not be considered of interest in prostate cancer for patients as defined in that stratum.
One stratum (up to 40 patients) will consist of patients who have had over 3 months (up to a maximum of 10 months) exposure to a taxane regimen, who then have documented progression of disease (initially taxane sensitive). The second stratum (up to 40 patients) will consist of patients considered primarily resistant to taxanes who have had documented progressive disease as best response after exposure to a single taxane regimen for less than or equal to 3 months. Patients may have received prior hormonal therapy and/or bisphosphonates and may continue on these therapies.
In the first stage of the trial, 22 patients in each stratum will be treated with TPI 287 intravenously every 21 days. If 1 or fewer patients in either stratum demonstrate a response in this first stage, the trial will be discontinued for that stratum. Otherwise, an additional 18 patients in the stratum showing 2 or more responses will be enrolled in the second stage of the study. If 4 or fewer patients demonstrate a response in the total study population in either stratum from stages 1 and 2, then the drug will not be considered of interest in prostate cancer for patients as defined in that stratum.
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?: