Suberoylanilide Hydroxamic Acid in Advanced Solid Tumors - Full Text View

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 Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: 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) ] [ 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
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


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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Sponsors and Collaborators

Merck Sharp & Dohme Corp.

Investigators


Study Director:	Medical Monitor	Merck Sharp & Dohme Corp.

More Information

No publications provided


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
Study First Received:	March 28, 2005
Results First Received:	November 25, 2008
Last Updated:	March 16, 2009
Health Authority:	United States: Food and Drug Administration

Keywords provided by Merck Sharp & Dohme Corp.:


Advanced solid tumors including MPM and NSCLC

Additional relevant MeSH terms:


Vorinostat Antineoplastic Agents Enzyme Inhibitors Histone Deacetylase Inhibitors	Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Therapeutic Uses

ClinicalTrials.gov processed this record on March 03, 2015