Suberoylanilide Hydroxamic Acid in Advanced Solid Tumors

Phase 1

Completed

• Conditions: Advanced Cancer
• Interventions: Drug: vorinostat (Suberoylanilide Hydroxamic Acid [SAHA]) in combination with Pemetrexed and Cisplatin

• Registration Number: NCT00106626
• Lead Sponsor: Merck Sharp & Dohme LLC

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2005-03-28
• Study First Submitted QC: 2005-03-28
• Study First Posted: 2005-03-29
• Study Start: 2005-08
• Primary Completion: 2007-12
• Study Completion: 2007-12
• Results First Submitted: 2008-11-25
• Status Verified: 2009-03
• Results First Submitted QC: 2009-03-16
• Last Update Submitted: 2009-03-16
• Results First Posted: 2009-04-22
• Last Update Posted: 2009-04-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	vorinostat (Suberoylanilide Hydroxamic Acid [SAHA]) in combination with Pemetrexed and Cisplatin	vorinostat (Suberoylanilide Hydroxamic Acid \[SAHA\])

Primary Outcome Measures

Name	Time	Method
Maximum Tolerated Dose (MTD) Status as Determined by Number of Participants With Dose Limiting Toxicity (DLT) at Each Dose Level	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

Name	Time	Method
Safety and Tolerability as Measured by the Number of Participants With Disease Progression	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.