Ignite Creation Date:
2024-05-05 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00053885
Status:
COMPLETED
Last Update Posted:
2016-07-01
First Post:
2003-02-05
Brief Title:
PTK787ZK 222584 in Treating Patients With Unresectable Malignant Mesothelioma
Sponsor:
Alliance for Clinical Trials in Oncology
Organization:
Alliance for Clinical Trials in Oncology
Study Overview
Official Title:
A Phase II Study of PTK787ZK222584 NSC719335 in Patients With Unresectable Malignant Mesothelioma
Status:
COMPLETED
Status Verified Date:
2016-06
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 PTK787ZK 222584 may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth
PURPOSE Phase II trial to study the effectiveness of PTK787ZK 222584 in treating patients with unresectable malignant mesothelioma
PURPOSE Phase II trial to study the effectiveness of PTK787ZK 222584 in treating patients with unresectable malignant mesothelioma
Detailed Description:
OBJECTIVES
Determine the efficacy of PTK787ZK 222584 in terms of 3-month progression-free survival in patients with malignant mesothelioma
Determine the response rate in patients treated with this drug
Determine the toxicity of this drug in these patients
Determine the overall and failure-free survival of patients treated with this drug
Correlate pretreatment circulating serum levels of vascular endothelial growth factor VEGF platelet-derived growth factor and VEGF mRNA isoforms with response in patients treated with this drug
OUTLINE This is a multicenter study
Patients receive oral PTK787ZK 222584 daily Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity
Patients are followed every 2 months for 1 year every 4 months for 1 year and then every 6 months for 1 year
Determine the efficacy of PTK787ZK 222584 in terms of 3-month progression-free survival in patients with malignant mesothelioma
Determine the response rate in patients treated with this drug
Determine the toxicity of this drug in these patients
Determine the overall and failure-free survival of patients treated with this drug
Correlate pretreatment circulating serum levels of vascular endothelial growth factor VEGF platelet-derived growth factor and VEGF mRNA isoforms with response in patients treated with this drug
OUTLINE This is a multicenter study
Patients receive oral PTK787ZK 222584 daily Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity
Patients are followed every 2 months for 1 year every 4 months for 1 year and then every 6 months for 1 year
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 |
|---|---|---|---|
| U10CA031946 | NIH | None | None |
| CALGB-30107 | None | None | None |
| CDR0000269537 | REGISTRY | NCI Physician Data Query | httpsreporternihgovquickSearchU10CA031946 |