Ignite Creation Date:
2024-05-05 @ 6:30 PM
Last Modification Date:
2024-10-26 @ 9:34 AM
Study NCT ID:
NCT00499135
Status:
COMPLETED
Last Update Posted:
2017-10-10
First Post:
2007-07-10
Brief Title:
Sunitinib Malate in Treating Patients With Unresectable or Metastatic Kidney Cancer or Other Advanced Solid Tumors
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Pharmacodynamic Study of Sunitinib Malate in Patients With Renal Cell Cancer and Other Advanced Solid Malignancies
Status:
COMPLETED
Status Verified Date:
2017-10
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 I trial is studying the side effects and best way to give sunitinib malate in treating patients with unresectable or metastatic kidney cancer or other advanced solid tumors Sunitinib malate may stop the growth of tumor cells by blocking blood flow to the tumor and by blocking some of the enzymes needed for cell growth
Detailed Description:
PRIMARY OBJECTIVES
I Determine the pharmacodynamic change using functional imaging 3-deoxy-3-18F fluorothymidine FLT-positron emission tomography PETcomputed tomography CT scans in patients with unresectable or metastatic clear cell renal cell carcinoma or other advanced solid malignancies treated with two different schedules of sunitinib malate
II Evaluate the objective response in patients treated with this drug
SECONDARY OBJECTIVES
I Measure the change in plasma vascular endothelial growth factor VEGF levels and plasma hypoxia-inducible factor HIF1-alpha levels as a potential mechanism for vascular endothelial growth factor receptor VEGFR tyrosine kinase inhibitor TKI failure and rapid tumor growth following VEGFR TKI withdrawal in these patients
II Correlate pharmacokinetics of this drug with response unexpected toxicity VEGF levels HIF1-alpha levels and FLT-PETCT scan changes
OUTLINE Patients are assigned to 1 of 2 different treatment schedules of sunitinib malate
SCHEDULE A Patients receive sunitinib malate orally PO once daily QD in weeks 1-4 Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity
SCHEDULE B Patients receive sunitinib malate PO QD in weeks 1 2 4 and 5 Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity
I Determine the pharmacodynamic change using functional imaging 3-deoxy-3-18F fluorothymidine FLT-positron emission tomography PETcomputed tomography CT scans in patients with unresectable or metastatic clear cell renal cell carcinoma or other advanced solid malignancies treated with two different schedules of sunitinib malate
II Evaluate the objective response in patients treated with this drug
SECONDARY OBJECTIVES
I Measure the change in plasma vascular endothelial growth factor VEGF levels and plasma hypoxia-inducible factor HIF1-alpha levels as a potential mechanism for vascular endothelial growth factor receptor VEGFR tyrosine kinase inhibitor TKI failure and rapid tumor growth following VEGFR TKI withdrawal in these patients
II Correlate pharmacokinetics of this drug with response unexpected toxicity VEGF levels HIF1-alpha levels and FLT-PETCT scan changes
OUTLINE Patients are assigned to 1 of 2 different treatment schedules of sunitinib malate
SCHEDULE A Patients receive sunitinib malate orally PO once daily QD in weeks 1-4 Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity
SCHEDULE B Patients receive sunitinib malate PO QD in weeks 1 2 4 and 5 Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity
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 |
|---|---|---|---|
| U01CA062491 | NIH | CTEP | httpsreporternihgovquickSearchU01CA062491 |
| NCI-2009-00245 | REGISTRY | None | None |
| CDR0000552705 | None | None | None |
| H-2007-0039 | None | None | None |
| CO06902 | None | None | None |
| CO 06902 | OTHER | None | None |
| 7898 | OTHER | None | None |
| P30CA014520 | NIH | None | None |