Phase I Study of Vorinostat and Sorafenib in Advanced Cancer

This study is currently recruiting participants.

Verified by University of Colorado, Denver, July 2009

First Received: March 7, 2008 Last Updated: July 2, 2009 History of Changes

Sponsor:	University of Colorado, Denver
Collaborators:	Merck Bayer
Information provided by:	University of Colorado, Denver
ClinicalTrials.gov Identifier:	NCT00635791

Purpose

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.

Condition	Intervention	Phase
Advanced Solid Tumors	Drug: Vorinostat and sorafenib	Phase I

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title:	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 (Renal Cell Carcinoma and Non-Small Cell Lung Carcinoma)

Resource links provided by NLM:

MedlinePlus related topics: Cancer

Drug Information available for: Suberoylanilide hydroxamic acid Sorafenib Sorafenib tosylate

U.S. FDA Resources

Further study details as provided by University of Colorado, Denver:

Estimated Enrollment:	50
Study Start Date:	March 2008
Estimated Primary Completion Date:	March 2010 (Final data collection date for primary outcome measure)

Intervention Details:

Part A - Sorafenib bid (or qd if necessary) daily, D1-21, from cycle 1 (21 day cycle), vorinostat once daily D1-14 or D1-21 (depending on cohort).

Parts B and C - Sorafenib bid (or qd if necessary) daily, D1-21, from cycle 1 (21 day cycle), vorinostat once daily D1-14 or D1-21 (depending on cohort).

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Eligibility criteria include but are not limited to:

18 years or older with advanced solid tumor(s),
Renal cell or non-small cell lung cancer.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00635791

Locations

United States, Colorado
University of Colorado Cancer Center	Recruiting
Aurora, Colorado, United States, 80045
Contact: Stacy Grolnic 720-848-0655 stacy.grolnic@ucdenver.edu

Sponsors and Collaborators

University of Colorado, Denver

Merck

Bayer

Investigators

Principal Investigator:

David R Camidge, MD

University of Colorado, Denver

More Information

No publications provided

Responsible Party:	University of Colorado Denver ( David Ross Camidge, MD )
Study ID Numbers:	07-0537
Study First Received:	March 7, 2008
Last Updated:	July 2, 2009
ClinicalTrials.gov Identifier:	NCT00635791 History of Changes
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Anticarcinogenic Agents
Thoracic Neoplasms
Anti-Inflammatory Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Protein Kinase Inhibitors
Neoplasms by Site
Respiratory Tract Diseases
Lung Neoplasms
Sensory System Agents
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Respiratory Tract Neoplasms

Neoplasms by Histologic Type
Vorinostat
Enzyme Inhibitors
Protective Agents
Pharmacologic Actions
Carcinoma
Neoplasms
Analgesics, Non-Narcotic
Lung Diseases
Peripheral Nervous System Agents
Antirheumatic Agents
Central Nervous System Agents
Sorafenib
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on February 08, 2010