Suberoylanilide Hydroxamic Acid in Advanced Solid Tumors
- Sponsor
- Merck Sharp & Dohme LLC
- Study ID
- NCT00106626
- Phase
- PHASE1
- Status
- Completed
Conditions
- Advanced Cancer
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- vorinostat (Suberoylanilide Hydroxamic Acid [SAHA]) in combination with Pemetrexed and Cisplatin — DRUGDose 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).
Study Details
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.
Key Dates
- Start date
- Aug 31, 2005
- Status verified
- Mar 2009
- Primary completion
- Dec 31, 2007
- Completion
- Dec 31, 2007
Study Design
- Enrollment
- 52 participants (actual)
- Allocation
- NON_RANDOMIZED
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: 1vorinostat (Suberoylanilide Hydroxamic Acid \[SAHA\])
Primary Outcome Measure
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) ]
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