Ignite Creation Date:
2025-12-25 @ 12:01 AM
Ignite Modification Date:
2025-12-25 @ 9:59 PM
Study NCT ID:
NCT00255658
Status:
COMPLETED
Last Update Posted:
2015-04-15
First Post:
2005-11-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Sorafenib and Temsirolimus in Treating Patients With Unresectable or Metastatic Solid Tumors
Sponsor:
National Cancer Institute (NCI)
Organization:
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 P13K/Akt/mTOR 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 P13K/Akt/mTOR 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:
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-2012-03164 | REGISTRY | CTRP (Clinical Trial Reporting Program) | View | |
| NCI-7146 | None | None | View | |
| U01CA069853 | NIH | None | https://reporter.nih.gov/quic… | View |
| CTRC-IDD-0512 | None | None | View | |
| CDR0000446567 | None | None | View | |
| IDD#05-12 | OTHER | Cancer Therapy and Research Center at The UT Health Science Center at San Antonio | View | |
| 7146 | OTHER | CTEP | View |