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Suberoylanilide Hydroxamic Acid in Advanced Solid Tumors

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ClinicalTrials.gov Identifier: NCT00106626
Recruitment Status : Completed
First Posted : March 29, 2005
Results First Posted : April 22, 2009
Last Update Posted : April 22, 2009
Sponsor:
Information provided by:
Merck Sharp & Dohme Corp.

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Advanced Cancer Drug: vorinostat (Suberoylanilide Hydroxamic Acid [SAHA]) in combination with Pemetrexed and Cisplatin Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 52 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I Clinical Trial of Suberoylanilide Hydroxamic Acid (SAHA) in Combination With Pemetrexed and Cisplatin in Patients With Advanced Cancer
Study Start Date : August 2005
Actual Primary Completion Date : December 2007
Actual Study Completion Date : December 2007

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Arms and Interventions
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Arm Intervention/treatment
Experimental: 1
vorinostat (Suberoylanilide Hydroxamic Acid [SAHA])
 Drug: vorinostat (Suberoylanilide Hydroxamic Acid [SAHA]) in combination with Pemetrexed and Cisplatin
Dose escalation study starting with vorinostat (Suberoylanilide Hydroxamic Acid [SAHA]) capsules 200 mg b.i.d. in combination with Pemetrexed and Cisplatin (see table for Reporting Groups).
Other Names:
  • MK0683
  • vorinostat
  • Suberoylanilide Hydroxamic Acid (SAHA)


Outcome Measures
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Primary Outcome Measures :
  1. 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) ]
    MTD was determined by the occurrence of DLTs during the first treatment cycle. DLT describes side effects of a drug or other treatment that are serious enough to prevent an increase in dose or level of that treatment. The dose level is equal to the MTD if < 2 patients experience a DLT and is also the highest tolerated dose level in the cohort.


Secondary Outcome Measures :
  1. 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. ]
    Number of participants with disease progression (protocol-mandated reason for discontinuation). Disease progression was determined by the principle investigator.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

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): NCT00106626


Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
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Study Director: Medical Monitor Merck Sharp & Dohme Corp.
More Information
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Responsible Party: Executive Vice President, Clinical and Quantitative Sciences, Merck & Co., Inc.
ClinicalTrials.gov Identifier: NCT00106626    
Other Study ID Numbers: 2005_006
MK0683-012
First Posted: March 29, 2005    Key Record Dates
Results First Posted: April 22, 2009
Last Update Posted: April 22, 2009
Last Verified: March 2009
Keywords provided by Merck Sharp & Dohme Corp.:
Advanced solid tumors including MPM and NSCLC
Additional relevant MeSH terms:
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Neoplasms
Cisplatin
Pemetrexed
Vorinostat
Antineoplastic Agents
 Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors
Histone Deacetylase Inhibitors