Ignite Creation Date:
2024-05-05 @ 5:18 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00424060
Status:
COMPLETED
Last Update Posted:
2012-09-24
First Post:
2007-01-16
Brief Title:
Epothilone ZK-219477 in Treating Patients With Recurrent Glioblastoma
Sponsor:
European Organisation for Research and Treatment of Cancer - EORTC
Organization:
European Organisation for Research and Treatment of Cancer - EORTC
Study Overview
Official Title:
Phase II Study of ZK 219477 in Patients With Recurrent Glioblastoma
Status:
COMPLETED
Status Verified Date:
2012-09
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:
RATIONALE Drugs used in chemotherapy such as epothilone ZK-219477 work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing
PURPOSE This phase II trial is studying how well epothilone ZK-219477 works in treating patients with recurrent glioblastoma
PURPOSE This phase II trial is studying how well epothilone ZK-219477 works in treating patients with recurrent glioblastoma
Detailed Description:
OBJECTIVES
Primary
Assess the therapeutic activity of epothilone ZK-219477 in patients with recurrent glioblastoma
Secondary
Determine the safety profile mechanism of action and pharmacokinetics of this drug in these patients
Gather information about the biological characteristics of the patients tumor that may provide information on response or resistance to this drug
OUTLINE This is a nonrandomized open-label multicenter study
Patients receive epothilone ZK-219477 IV over 3 hours on day 1 Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity
Blood samples are collected at baseline for biomarker analysis and for comparison of genetic alterations in tumor tissue with germline DNA Blood samples are also collected periodically during course 1 for pharmacokinetic studies Tumor tissue obtained at diagnosis and possibly recurrence is used for immunohistochemical analyses for biomarkers Fluorescent in situ hybridization FISH is used to detect genetic alterations and gene expression
After completion of study treatment patients are followed every 3 months
PROJECTED ACCRUAL A total of 35 patients will be accrued for this study
Primary
Assess the therapeutic activity of epothilone ZK-219477 in patients with recurrent glioblastoma
Secondary
Determine the safety profile mechanism of action and pharmacokinetics of this drug in these patients
Gather information about the biological characteristics of the patients tumor that may provide information on response or resistance to this drug
OUTLINE This is a nonrandomized open-label multicenter study
Patients receive epothilone ZK-219477 IV over 3 hours on day 1 Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity
Blood samples are collected at baseline for biomarker analysis and for comparison of genetic alterations in tumor tissue with germline DNA Blood samples are also collected periodically during course 1 for pharmacokinetic studies Tumor tissue obtained at diagnosis and possibly recurrence is used for immunohistochemical analyses for biomarkers Fluorescent in situ hybridization FISH is used to detect genetic alterations and gene expression
After completion of study treatment patients are followed every 3 months
PROJECTED ACCRUAL A total of 35 patients will be accrued for this study
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| SPRI-EORTC-26061 | None | None | None |
| EORTC-26061 | None | None | None |
| EUDRACT-2006-001659-37 | None | None | None |