Phase 1
N=52
Suberoylanilide Hydroxamic Acid in Advanced Solid Tumors
Advanced Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00106626 ↗Enrolled (actual)
52
Serious AEs
—
Results posted
Apr 2009
Primary outcome: Primary: Maximum Tolerated Dose (MTD) Status as Determined by Number of Participants With Dose Limiting Toxicity (DLT) at Each Dose Level — 1; 3; 0; 2 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- vorinostat (Suberoylanilide Hydroxamic Acid [SAHA]) in combination with Pemetrexed and Cisplatin (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Merck Sharp & Dohme LLC
- Primary completion
- Dec 2007
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maximum Tolerated Dose (MTD) Status as Determined by Number of Participants With Dose Limiting Toxicity (DLT) at Each Dose Level |
1; 3; 0; 2; 1; 0 | — |
| SECONDARY Safety and Tolerability as Measured by the Number of Participants With Disease Progression |
4; 1; 9; 10 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT00106626). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.