Study of Oral PXD101 in Patients With Advanced Solid Tumors or Lymphoma
- Registration Number
- NCT00413075
- Lead Sponsor
- Valerio Therapeutics
- Brief Summary
This is a Phase I dose escalation study of PXD101 administered orally. Oral belinostat will be given once or twice daily at various dosing schedules to patients with solid tumors. Doses will be escalated until the maximum tolerated dose (MTD) is identified. In parallel, a cohort of lymphoma patients will be given oral belinostat on a discontinuous once daily dosing schedule.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 121
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description oral belinostat oral belinostat -
- Primary Outcome Measures
Name Time Method Safety, tolerability and maximum tolerated dose of orally administered PXD101 for each cohort throughout the study
- Secondary Outcome Measures
Name Time Method Determine the pharmacokinetics of oral PXD101 when dosed once or twice daily at various dose levels throughout the study Explore anti-tumor activity throughout the study Determine the safety, tolerability, and anti-tumor activity of orally administered PXD101 to patients with lymphoma throughout the trial
Trial Locations
- Locations (5)
New York University Cancer Institute
🇺🇸New York, New York, United States
Yale New Haven Hospital
🇺🇸New Haven, Connecticut, United States
Research Facility
🇬🇧London, Surrey, United Kingdom
Columbia University - Herbert Irving Cancer Center
🇺🇸New York, New York, United States
M.D. Anderson Cancer Center
🇺🇸Houston, Texas, United States