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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00255658
Other study ID # NCI-2012-03164
Secondary ID NCI-2012-03164NC
Status Completed
Phase Phase 1
First received November 18, 2005
Last updated April 14, 2015
Start date September 2005
Est. completion date April 2007

Study information

Verified date December 2013
Source National Cancer Institute (NCI)
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.


Description:

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Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms

  • Unspecified Adult Solid Tumor, Protocol Specific

Intervention

Drug:
sorafenib tosylate
Given orally
temsirolimus
Given IV
Other:
laboratory biomarker analysis
Correlative studies

Locations

Country Name City State
United States Cancer Therapy and Research Center at The UT Health Science Center at San Antonio San Antonio Texas

Sponsors (1)

Lead Sponsor Collaborator
National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Maximum tolerable dose (MTD) and recommended dose for phase II determined by dose-limiting toxicities (DLT) graded according to NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 4 weeks Yes
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