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Trial record 1 of 1 for:    NCT00635791
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Phase I Study of Vorinostat and Sorafenib in Advanced Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2009 by University of Colorado, Denver.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Merck
Bayer
Information provided by:
University of Colorado, Denver
ClinicalTrials.gov Identifier:
NCT00635791
First received: March 7, 2008
Last updated: July 2, 2009
Last verified: July 2009
History of Changes
  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 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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
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:
    Drug: Vorinostat and sorafenib

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

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
 Vorinostat
Sorafenib
Histone Deacetylase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Protein Kinase Inhibitors

ClinicalTrials.gov processed this record on June 18, 2013