Suberoylanilide Hydroxamic Acid in Advanced Solid Tumors - Full Text View

Sponsor:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00106626

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 I

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study
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:

MedlinePlus related topics: Cancer

Drug Information available for: Cisplatin Pemetrexed Suberoylanilide hydroxamic acid Pemetrexed disodium

U.S. FDA Resources

Further study details as provided by Merck:

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) ] [ Designated as safety issue: Yes ]

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. ] [ Designated as safety issue: Yes ]

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
1: Experimental 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).

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00106626

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

No publications provided

Responsible Party:	Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences )
Study ID Numbers:	2005_006, MK0683-012
Study First Received:	March 28, 2005
Results First Received:	November 25, 2008
Last Updated:	March 16, 2009
ClinicalTrials.gov Identifier:	NCT00106626 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Merck:

Advanced solid tumors including MPM and NSCLC

Additional relevant MeSH terms:

Anticarcinogenic Agents
Anti-Inflammatory Agents
Antimetabolites
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Vorinostat
Physiological Effects of Drugs
Enzyme Inhibitors
Folic Acid Antagonists
Protective Agents
Pharmacologic Actions

Pemetrexed
Neoplasms
Cisplatin
Radiation-Sensitizing Agents
Sensory System Agents
Analgesics, Non-Narcotic
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Peripheral Nervous System Agents
Analgesics
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on November 25, 2009