Clinical Trial: Study of Oral PXD101 in Patients With Advanced Solid Tumors or Lymphoma
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Open Label, Dose Escalation Trial of Oral PXD101 in Patients With Advanced Solid Tumors
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 Summary:
Sponsor: Onxeo
Current Primary Outcome: Safety, tolerability and maximum tolerated dose of orally administered PXD101 for each cohort [ Time Frame: throughout the study ]
Original Primary Outcome:
- Safety, tolerability and pharmacokinetics of orally administered PXD101 for each cohort.
- Establish an MTD for once daily dosing and twice daily dosing in patients with advanced solid tumors, by study end.
Current Secondary Outcome:
- Determine the pharmacokinetics of oral PXD101 when dosed once or twice daily at various dose levels [ Time Frame: throughout the study ]
- Explore anti-tumor activity [ Time Frame: throughout the study ]
- Determine the safety, tolerability, and anti-tumor activity of orally administered PXD101 to patients with lymphoma [ Time Frame: throughout the trial ]
Original Secondary Outcome:
- Determine the pharmacokinetics of oral PXD101 when dosed once or twice daily at various dose levels.
- Explore anti-tumor activity, by study end.
Information By: Onxeo
Dates:
Date Received: December 18, 2006
Date Started: June 2006
Date Completion:
Last Updated: July 7, 2015
Last Verified: July 2015
