Ignite Creation Date:
2025-12-24 @ 10:17 PM
Ignite Modification Date:
2026-01-01 @ 3:01 AM
Study NCT ID:
NCT00499135
Status:
COMPLETED
Last Update Posted:
2017-10-10
First Post:
2007-07-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sunitinib Malate in Treating Patients With Unresectable or Metastatic Kidney Cancer or Other Advanced Solid Tumors
Sponsor:
National Cancer Institute (NCI)
Organization:
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 \[PET\]/computed 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 (HIF)1-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-PET/CT 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 \[PET\]/computed 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 (HIF)1-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-PET/CT 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:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2009-00245 | REGISTRY | CTRP (Clinical Trial Reporting Program) | View | |
| CDR0000552705 | None | None | View | |
| H-2007-0039 | None | None | View | |
| CO06902 | None | None | View | |
| CO 06902 | OTHER | University of Wisconsin Hospital and Clinics | View | |
| 7898 | OTHER | CTEP | View | |
| P30CA014520 | NIH | None | https://reporter.nih.gov/quic… | View |
| U01CA062491 | NIH | None | https://reporter.nih.gov/quic… | View |