A Study of Oral Suberoylanilide Hydroxamic Acid (SAHA) in Patients With Malignant Lymphoma (0683-030)
- Registration Number
- NCT00127140
- Lead Sponsor
- Merck Sharp & Dohme LLC
- Brief Summary
The primary purpose of this trial is to determine the maximum tolerated dose (MTD), or the maximum acceptable dose (MAD) and evaluate the dose limiting toxicity (DLT) of oral vorinostat in patients with malignant lymphoma.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 10
Inclusion Criteria
- Patients who relapsed after complete or partial response, or ineffective in previous chemotherapy
Exclusion Criteria
- Patients with history of chemotherapy, antibody therapy, radiotherapy, during the previous 4 weeks (6 months for radioisotope-labeled antibody)
- Any uncontrolled concomitant illness
- Are pregnant or breast-feeding
- Serious drug or food allergy
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Vorinostat vorinostat Participants received (Cycle 1) once-daily vorinostat at assigned dose (100 or 200 mg) on Days 1 and 17 and twice-daily on Days 3-16. Thereafter, participants remaining on study received the same dose level therapy twice-daily for 14 consecutive days followed by 7 days of rest.
- Primary Outcome Measures
Name Time Method Number of participants Experiencing Dose-Limiting Toxicities (DLTs) Up to 21 days
- Secondary Outcome Measures
Name Time Method Area Under the Curve (AUC) of Vorinostat After Single Oral Dosing Pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours post-dose on Days 1 and 17