closed due to toxicity
A Phase I Study of Suberoylanilide Hydroxamic Acid (Vorinostat) (NSC 701852) in Combination With Docetaxel in Patients With Advanced and Relapsed Solid Malignancies
Sponsor study identifier
interventional
12
1 country
1
Study Start
April 2007
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
November 2008
Actual (reported)Study Completion
September 2009
Actual (reported)Vorinostat (Suberoylanilide Hydroxamic Acid; NSC 701852) is a drug that inhibits an enzyme that plays a key role in the regulation of cell survival, growth, and eventual cell death, all of which play a role in cancer. As a result, this drug has the potential to affect a tumor's ability to survive. Vorinostat is the most potent drug of its kind that is currently under investigation in clinical trials. The primary objective of this study is to define the maximum safest dose of vorinostat in combination with a standard chemotherapy agent, docetaxel, in patients with advanced and relapsed lung, bladder, or prostate cancer.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 2009
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 2007
Date type not reportedThis date has not been verified as actual or estimated.
November 27, 2007
Actual (reported)November 29, 2007
Actual (reported)November 2008
Actual (reported)September 2009
Actual (reported)The TITE-CRM dose escalation scheme will be used in this study to determine the maximum tolerated dose (MTD) of the combination therapy.
After 25 evaluable patients are accrued, a final set of side-effect estimates will be produced for each dose level, and the MTD will be the highest dose with a side-effect estimate at or below the target toxicity estimate of 30%.
Although response is not the primary endpoint of this trial, patients with measurable disease will be assessed by standard criteria.
For the purposes of this study, tumor response will be assessed every 6 weeks.
To evaluate the blood levels of vorinostat and docetaxel when administered in combination.
All blood levels of the drugs will be conducted during the first cycle of chemotherapy only.
Vorinostat will be administered by mouth as a pill for the first 14 days on a continuous basis during of each 21-day cycle (2 weeks of treatment, 1 week break).
Docetaxel will be administered as an intravenous infusion (through the vein) on day 4 of each 21-day cycle.
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, 48109, United States
Deborah Bradley, MD
University of Michigan Rogel Cancer Center
12 participants (actual enrollment reported by the registry).
First Submitted
November 27, 2007
First Posted
November 29, 2007
Study Start
April 2007
Date type not reportedThis date has not been verified as actual or estimated.
Phase I Study of Vorinostat and Sorafenib in Advanced Cancer
Contact the study team to confirm eligibility.
Primary Completion
November 2008
Actual (reported)Study Completion
September 2009
Actual (reported)Last Updated
December 2, 2016
Record last verified: 2016-12
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Source: ClinicalTrials.gov.
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