Suberoylanilide Hydroxamic Acid in Advanced Solid Tumors

Merck Sharp & Dohme (MSD)

Status and phase

Completed

Phase 1

Conditions

Advanced Cancer

Treatments

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

Study type

Interventional

Funder types

Industry

Identifiers

NCT00106626

MK0683-012

2005_006

Details and patient eligibility

About

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.

Enrollment

52 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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