SNPMiner Trials by Shray Alag

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Report for Clinical Trial NCT00255658

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

Phase I, Pharmacokinetic and Pharmacodynamic Study of BAY 43-9006 (Sorafenib) in Combination With CCI-779 (Temsirolimus) in Advanced Solid Malignancies

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.

NCT00255658 Unspecified Adult Solid Tumor, Protocol Specific

3 Interventions

Name: sorafenib tosylate

Description: Given orally
Type: Drug
Group Labels: 2

Treatment (sorafe Treatment (sorafenib tosylate, temsirolimus)

Name: temsirolimus

Description: Given IV
Type: Drug
Group Labels: 1

Treatment (sorafenib tosylate, temsirolimus)

Name: laboratory biomarker analysis

Description: Correlative studies
Type: Other
Group Labels: 1

Treatment (sorafenib tosylate, temsirolimus)

Primary Outcomes

Measure: 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

Time: 4 weeks

Purpose: Treatment

Allocation: N/A

Single Group Assignment

There is one SNP


1 P13K

To analyze the biologic effects of BAY 43-9006 and CCI-779 on downstream targets of the P13K/Akt/mTOR and Raf signaling pathways. --- P13K ---

HPO Nodes