Phase I Study of Vorinostat and Sorafenib in Advanced Cancer
|ClinicalTrials.gov Identifier: NCT00635791|
Recruitment Status : Completed
First Posted : March 14, 2008
Last Update Posted : June 20, 2013
|Condition or disease||Intervention/treatment||Phase|
|Malignant Solid Tumour Renal Cell Carcinoma Non Small Cell Lung Carcinoma||Drug: Sorafenib Drug: Vorinostat||Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||36 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||March 2008|
|Primary Completion Date :||October 2011|
|Study Completion Date :||March 2012|
Experimental: Sorafenib tosylate and vorinostat
Patients receive sorafenib tosylate by mouth twice a day on days 1-21 and vorinostat by mouth every day on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Given by mouth
Other Name: NexAVARDrug: Vorinostat
Given by mouth
Other Name: Zolinza
- Maximum tolerated dose (MTD) [ Time Frame: Up to 21 days ]The primary objective of this study is to determine the MTD for vorinostat in combination with the recommended dose of sorafenib 400 mg when given daily in a 21-day cycle and thereby establish a recommended Phase 2 dose of the combinations when administered daily in patients with advanced solid tumors
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00635791
|United States, Colorado|
|University of Colorado Cancer Center|
|Aurora, Colorado, United States, 80045|
|Principal Investigator:||David R Camidge, MD, PhD||University of Colorado, Denver|