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Clinical Trials/NCT00413075
NCT00413075CompletedPhase 1

Open Label, Dose Escalation Trial of Oral PXD101 in Patients With Advanced Solid Tumors

Valerio Therapeutics5 sites in 2 countries121 target enrollmentStarted: June 2006Last updated:
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Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 1
Status
Completed
Enrollment
121
Locations
5
Primary Endpoint
Safety, tolerability and maximum tolerated dose of orally administered PXD101 for each cohort
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Arms & Interventions

oral belinostat

Experimental

Intervention: oral belinostat (Drug)

Outcomes

Primary Outcomes

Safety, tolerability and maximum tolerated dose of orally administered PXD101 for each cohort

Time Frame: throughout the study

Secondary Outcomes

  • 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)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (5)

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