NCT00635791

Phase I Study of Vorinostat and Sorafenib in Advanced Cancer

A Phase I Safety and Tolerability Study of Vorinostat in Combination With Sorafenib in Patients With Advanced Solid Tumors, With Exploration of Two Tumor-type Specific Expanded Cohorts at the Recommended Phase 2 Dose

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: University of Colorado, Denver · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase I trial studies the side effects and best dose of giving vorinostat and sorafenib tosylate together in treating patients with kidney or non-small cell lung cancer. Vorinostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Sorafenib tosylate may stop the growth of solid tumors by blocking blood flow to the tumor. Giving vorinostat together with sorafenib tosylate may kill more tumor cells.

Detailed description

The main purpose of this study is to: * Evaluate the safety of vorinostat in combination with sorafenib. * Determine the largest dose of vorinostat + sorafenib that can be given safely to humans. * Determine if vorinostat + sorafenib are effective in stopping tumors from growing or in decreasing their size. * Study the side effects of vorinostat + sorafenib.

Conditions

• Malignant Solid Tumour
• Renal Cell Carcinoma
• Non Small Cell Lung Carcinoma

Interventions

Type	Name	Description
DRUG	Sorafenib	Given by mouth
DRUG	Vorinostat	Given by mouth

Timeline

• Start date: 2008-03-01
• Primary completion: 2011-10-01
• Completion: 2012-03-01
• First posted: 2008-03-14
• Last updated: 2013-06-20

Locations

1 site across 1 country: United States