Ignite Creation Date:
2024-05-05 @ 12:08 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00255658
Status:
COMPLETED
Last Update Posted:
2015-04-15
First Post:
2005-11-18
Brief Title:
Sorafenib and Temsirolimus in Treating Patients With Unresectable or Metastatic Solid Tumors
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase I Pharmacokinetic and Pharmacodynamic Study of BAY 43-9006 Sorafenib in Combination With CCI-779 Temsirolimus in Advanced Solid Malignancies
Status:
COMPLETED
Status Verified Date:
2013-12
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 in treating patients with unresectable or metastatic solid tumors 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 temsirolimus may kill more tumor cells
Detailed Description:
PRIMARY OBJECTIVES
I To characterize the safety and the toxicities of BAY 43-9006 sorafenib administered continuously twice daily by oral route in combination with CCI-779 temsirolimus administered intravenously once weekly in advanced solid malignancies
II To determine the maximum-tolerated dose MTD and recommended dose for the phase II study RD of this regimen
III To describe the pharmacokinetic behavior of BAY 43-9006 sorafenib and CCI-779 temsirolimus when combined
SECONDARY OBJECTIVES
I To evaluate the relationship between pharmacokinetic PK parameters of exposure and drug effect on biological surrogates of proliferation cell survival differentiation and angiogenesis in peripheral blood mononuclear cells PBMCs and tumor tissue where the tumor is accessible for biopsy
II To analyze the biologic effects of BAY 43-9006 and CCI-779 on downstream targets of the P13KAktmTOR and Raf signaling pathways
III To evaluate preliminary antitumor activity of the combination
OUTLINE This is an open-label dose-escalation study of temsirolimus
Patients receive temsirolimus IV over 30 minutes on days 1 8 15 and 22 They also receive oral sorafenib twice daily starting on day 8 of course 1 Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity
NOTE On the days of the temsirolimus infusion temsirolimus should be taken concurrently with the morning dose of sorafenib
Cohorts of 3-6 patients receive escalating doses of temsirolimus until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity Up to 12 patients are treated at the MTD
After completion of study treatment patients are followed for 4 weeks
I To characterize the safety and the toxicities of BAY 43-9006 sorafenib administered continuously twice daily by oral route in combination with CCI-779 temsirolimus administered intravenously once weekly in advanced solid malignancies
II To determine the maximum-tolerated dose MTD and recommended dose for the phase II study RD of this regimen
III To describe the pharmacokinetic behavior of BAY 43-9006 sorafenib and CCI-779 temsirolimus when combined
SECONDARY OBJECTIVES
I To evaluate the relationship between pharmacokinetic PK parameters of exposure and drug effect on biological surrogates of proliferation cell survival differentiation and angiogenesis in peripheral blood mononuclear cells PBMCs and tumor tissue where the tumor is accessible for biopsy
II To analyze the biologic effects of BAY 43-9006 and CCI-779 on downstream targets of the P13KAktmTOR and Raf signaling pathways
III To evaluate preliminary antitumor activity of the combination
OUTLINE This is an open-label dose-escalation study of temsirolimus
Patients receive temsirolimus IV over 30 minutes on days 1 8 15 and 22 They also receive oral sorafenib twice daily starting on day 8 of course 1 Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity
NOTE On the days of the temsirolimus infusion temsirolimus should be taken concurrently with the morning dose of sorafenib
Cohorts of 3-6 patients receive escalating doses of temsirolimus until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity Up to 12 patients are treated at the MTD
After completion of study treatment patients are followed for 4 weeks
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-2012-03164 | REGISTRY | None | None |
| NCI-7146 | None | None | None |
| U01CA069853 | NIH | None | None |
| CTRC-IDD-0512 | None | None | None |
| CDR0000446567 | None | None | None |
| IDD05-12 | OTHER | None | None |
| 7146 | OTHER | CTEP | httpsreporternihgovquickSearchU01CA069853 |