Ignite Creation Date:
2024-05-05 @ 5:27 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00453310
Status:
COMPLETED
Last Update Posted:
2015-10-27
First Post:
2007-03-27
Brief Title:
Sunitinib in Treating Patients With Metastatic Germ Cell Tumors That Have Relapsed or Not Responded to Treatment
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
Memorial Sloan Kettering Cancer Center
Study Overview
Official Title:
A Phase II Study of Sunitinib in Patients With Refractory or Relapsed Germ Cell Tumors
Status:
COMPLETED
Status Verified Date:
2015-09
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 Sunitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor
PURPOSE This phase II trial is studying how well sunitinib works in treating patients with metastatic germ cell tumors that have relapsed or not responded to treatment
PURPOSE This phase II trial is studying how well sunitinib works in treating patients with metastatic germ cell tumors that have relapsed or not responded to treatment
Detailed Description:
OBJECTIVES
Primary
Determine the efficacy of sunitinib malate in patients with refractory or relapsed metastatic germ cell tumors
Secondary
Determine the safety of this drug in these patients
Determine the time to tumor response and duration of tumor response in patients treated with this drug
OUTLINE This is a open-label study
Patients receive oral sunitinib malate once daily on days 1-28 Treatment repeats every 6 weeks for up to 9 courses in the absence of disease progression or unacceptable toxicity
After completion of study therapy patients are followed at 28 days and then periodically thereafter
Primary
Determine the efficacy of sunitinib malate in patients with refractory or relapsed metastatic germ cell tumors
Secondary
Determine the safety of this drug in these patients
Determine the time to tumor response and duration of tumor response in patients treated with this drug
OUTLINE This is a open-label study
Patients receive oral sunitinib malate once daily on days 1-28 Treatment repeats every 6 weeks for up to 9 courses in the absence of disease progression or unacceptable toxicity
After completion of study therapy patients are followed at 28 days and then periodically 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 |
|---|---|---|---|
| P30CA008748 | NIH | None | None |
| MSKCC-07004 | US NIH GrantContract | None | httpsreporternihgovquickSearchP30CA008748 |