Suberoylanilide Hydroxamic Acid in Advanced Solid Tumors

NCT ID: NCT00106626

Last Updated: 2009-04-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-08-31
• Study Completion Date: 2007-12-31

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.

Conditions

Advanced Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

vorinostat (Suberoylanilide Hydroxamic Acid \[SAHA\])

Group Type: EXPERIMENTAL

vorinostat (Suberoylanilide Hydroxamic Acid [SAHA]) in combination with Pemetrexed and Cisplatin

Intervention Type: DRUG

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).

Interventions

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).

Intervention Type: DRUG

Other Intervention Names

MK0683; vorinostat; Suberoylanilide Hydroxamic Acid (SAHA)

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Merck & Co., Inc.

Principal Investigators

Medical Monitor

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Other Identifiers

MK0683-012

Identifier Type: -

Identifier Source: secondary_id

2005_006

Identifier Type: -

Identifier Source: org_study_id