Full Text View
Tabular View
Study Results
Related Studies
Suberoylanilide Hydroxamic Acid in Advanced Solid Tumors
This study has been completed.
Study NCT00106626   Information provided by Merck
First Received: March 28, 2005   Last Updated: March 16, 2009   History of Changes

March 28, 2005
March 16, 2009
August 2005
December 2007   (final data collection date for primary outcome measure)
Maximum Tolerated Dose (MTD) Status as Determined by Number of Participants With Dose Limiting Toxicity (DLT) at Each Dose Level [ Time Frame: Cycle 1 (21 days) ] [ Designated as safety issue: Yes ]
Maximum tolerated dose (MTD)
Complete list of historical versions of study NCT00106626 on ClinicalTrials.gov Archive Site
Safety and Tolerability as Measured by the Number of Participants With Disease Progression [ Time Frame: Any time during 8 cycle treatment period through 30 days after. ] [ Designated as safety issue: Yes ]
Pharmacokinetics
 
Suberoylanilide Hydroxamic Acid in Advanced Solid Tumors
Phase I Clinical Trial of Suberoylanilide Hydroxamic Acid (SAHA) in Combination With Pemetrexed and Cisplatin in Patients With Advanced Cancer

The purpose of this investigational study is to determine the safety and tolerability of oral suberoylanilide hydroxamic acid when administered in combination with standard doses of pemetrexed and cisplatin for the treatment of advanced solid tumors.

 
Phase I
Interventional
Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study
Advanced Cancer
Drug: vorinostat (Suberoylanilide Hydroxamic Acid [SAHA]) in combination with Pemetrexed and Cisplatin
Experimental: vorinostat (Suberoylanilide Hydroxamic Acid [SAHA])
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
52
December 2007
December 2007   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patient must be 18 years or older with confirmed diagnosis of a solid tumor for which pemetrexed and cisplatin is acceptable treatment and have received no more than 2 prior systemic therapies
  • Has at least 1 measurable lesion
  • Has adequate blood, liver, and kidney functions
  • Has not received any chemotherapy for at least 4 weeks prior to entry in this study
  • Agrees to take adequate measures to prevent pregnancy as outlined in the protocol

Exclusion Criteria:

  • Patient has been treated with other investigational agents with a similar anti-tumor mechanism
  • Patient from Cohorts A and B has received pemetrexed or cisplatin within the past 6 months and from Cohorts C and D have received pemetrexed within the past 6 months
  • Patient from Cohorts A and B has preexisting Grade 2 or higher neuropathy and from Cohorts C and D have Grade 3 or higher neuropathy
  • Patient has active infection or had received IV (intravenous) antibiotic, antiviral, or antifungal medications within 2 weeks of the start of study drugs
  • Patient has HIV, hepatitis B or hepatitis C infection
  • Patient is pregnant or breast feeding
  • Patient has allergy to any component of the study drugs
  • Patient has history of GI (gastrointestinal) surgery or conditions
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
 
 
NCT00106626
Executive Vice President, Clinical and Quantitative Sciences, Merck & Co., Inc.
2005_006, MK0683-012
Merck
 
Study Director: Medical Monitor Merck
Merck
March 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP