Ignite Creation Date:
2025-12-26 @ 4:02 PM
Ignite Modification Date:
2025-12-30 @ 5:34 AM
Study NCT ID:
NCT00349206
Status:
COMPLETED
Last Update Posted:
2014-04-10
First Post:
2006-07-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sorafenib and Temsirolimus in Treating Patients With Metastatic, Recurrent, or Unresectable Melanoma
Sponsor:
National Cancer Institute (NCI)
Organization:
Study Overview
Official Title:
Phase 1 Study of the Combination of BAY 43-9006 (Sorafenib) and CCI-779 (Temsirolimus) in Patients With Metastatic Melanoma
Status:
COMPLETED
Status Verified Date:
2013-02
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 dose of temsirolimus when given together with sorafenib and to see how well they work in treating patients with metastatic, recurrent, or unresectable melanoma. Sorafenib and temsirolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Sorafenib may also stop the growth of tumor cells by blocking blood flow to the tumor. Giving sorafenib together with temosirolimus may kill more tumor cells.
Detailed Description:
PRIMARY OBJECTIVES:
I. To determine the maximum tolerated dose of temsirolimus when administered with sorafenib in patients with metastatic, recurrent, or unresectable melanoma.
II. To determine the safety and toxicity of this regimen in these patients.
SECONDARY OBJECTIVES:
I. To Determine the population pharmacokinetics of this regimen in these patients.
II. To correlate tumor and blood biomarkers with clinical outcome in patients treated with this regimen.
OUTLINE: This is a multicenter, phase I, dose-escalation study followed by a phase II, open-label study (2005-0215).
Patients receive temsirolimus IV over 30 minutes on days 1, 8, 15, and 22 and oral sorafenib once or twice daily on days 1-28. Treatment course repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 3-6 months.
I. To determine the maximum tolerated dose of temsirolimus when administered with sorafenib in patients with metastatic, recurrent, or unresectable melanoma.
II. To determine the safety and toxicity of this regimen in these patients.
SECONDARY OBJECTIVES:
I. To Determine the population pharmacokinetics of this regimen in these patients.
II. To correlate tumor and blood biomarkers with clinical outcome in patients treated with this regimen.
OUTLINE: This is a multicenter, phase I, dose-escalation study followed by a phase II, open-label study (2005-0215).
Patients receive temsirolimus IV over 30 minutes on days 1, 8, 15, and 22 and oral sorafenib once or twice daily on days 1-28. Treatment course repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 3-6 months.
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-2009-00131 | REGISTRY | CTRP (Clinical Trial Reporting Program) | View | |
| 2005-0215 | None | None | View | |
| CDR0000480157 | None | None | View | |
| 2005-0215 | OTHER | M D Anderson Cancer Center | View | |
| 7149 | OTHER | CTEP | View | |
| P30CA016672 | NIH | None | https://reporter.nih.gov/quic… | View |
| N01CM62202 | NIH | None | https://reporter.nih.gov/quic… | View |