Phase I Study of Vorinostat and Sorafenib in Advanced Cancer
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|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|
|Actual Primary Completion Date :||October 2011|
|Actual 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|