Ignite Creation Date:
2024-05-05 @ 5:10 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00392444
Status:
COMPLETED
Last Update Posted:
2014-05-21
First Post:
2006-10-25
Brief Title:
Sunitinib in Treating Patients With Advanced Malignant Pleural Mesothelioma
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase II Study of Sunitinib SU11248 NSC 736511 IND 74019 in Patients With Advanced Malignant Pleural Mesothelioma
Status:
COMPLETED
Status Verified Date:
2013-04
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 phase II trial is studying how well sunitinib works in treating patients with advanced malignant mesothelioma of the pleura Sunitinib may stop the growth of tumor cells by blocking some of the enzymes needed for their growth
Detailed Description:
PRIMARY OBJECTIVES
I Assess the efficacy of sunitinib malate in terms of response rate complete and partial in patients with malignant pleural mesothelioma
II Assess the toxicity safety and tolerability of this drug in these patients
III Assess the duration of response or stable disease stable disease rate progression-free survival and median and overall survival rates
OUTLINE This is a multicenter nonrandomized open-label study Patients are stratified according to prior cytotoxic chemotherapy yes vs no
Patients receive oral sunitinib malate once daily on days 1-28 Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed at 4 weeks and then every 3 months thereafter
I Assess the efficacy of sunitinib malate in terms of response rate complete and partial in patients with malignant pleural mesothelioma
II Assess the toxicity safety and tolerability of this drug in these patients
III Assess the duration of response or stable disease stable disease rate progression-free survival and median and overall survival rates
OUTLINE This is a multicenter nonrandomized open-label study Patients are stratified according to prior cytotoxic chemotherapy yes vs no
Patients receive oral sunitinib malate once daily on days 1-28 Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed at 4 weeks and then every 3 months thereafter
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 |
|---|---|---|---|
| NCI-2009-00693 | REGISTRY | None | None |
| CDR0000652058 | None | None | None |
| NCIC-183 | OTHER | None | None |
| NCIC-183 | OTHER | CTEP | None |