Suberoylanilide Hydroxamic Acid in Advanced Solid Tumors

This study has been completed.

Sponsor:

ClinicalTrials.gov Identifier:

NCT00106626

First Posted: March 29, 2005

Last Update Posted: July 29, 2009

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

Information provided by:

Merck Sharp & Dohme Corp.

Purpose

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


Study Type:	Interventional
Study Design:	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

Resource links provided by NLM:

Drug Information available for: Cisplatin Pemetrexed Vorinostat Pemetrexed disodium

U.S. FDA Resources

Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:

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) ]

Secondary Outcome Measures:

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. ]


Enrollment:	52
Study Start Date:	August 2005
Study Completion Date:	December 2007
Primary Completion Date:	December 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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)

Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
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

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


Study Director:	Medical Monitor	Merck Sharp & Dohme Corp.

More Information


Responsible Party:	Executive Vice President, Clinical and Quantitative Sciences, Merck & Co., Inc.
ClinicalTrials.gov Identifier:	NCT00106626 History of Changes
Other Study ID Numbers:	2005_006 MK0683-012
First Submitted:	March 28, 2005
First Posted:	March 29, 2005
Results First Submitted:	November 25, 2008
Results First Posted:	April 22, 2009
Last Update Posted:	July 29, 2009
Last Verified:	March 2009

Keywords provided by Merck Sharp & Dohme Corp.:


Advanced solid tumors including MPM and NSCLC

Additional relevant MeSH terms:


Vorinostat Cisplatin Pemetrexed Antineoplastic Agents Enzyme Inhibitors	Molecular Mechanisms of Pharmacological Action Folic Acid Antagonists Nucleic Acid Synthesis Inhibitors Histone Deacetylase Inhibitors

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