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NCT00413075 · ClinicalTrials.gov registry record · Phase 1

Study of Oral PXD101 in Patients With Advanced Solid Tumors or Lymphoma

A Phase 1 study, sponsored by Valerio Therapeutics.

Completed
Registry status
Phase 1
Development phase
121
Enrollment target

NCT00413075: Completed Phase 1 study, sponsored by Valerio Therapeutics.

NCT00413075 is a Phase 1 study that has completed, run by Valerio Therapeutics. The registered enrollment target is 121 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (102% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00413075, a Phase 1 study, has completed, sponsored by Valerio Therapeutics.

COMPLETED
Registry status
Phase 1
Development phase
121 participants
Enrollment target

Study 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.

Interventions

  • DRUG oral belinostat

Trial Details

FieldValue
Enrollment Target 121 participants
Start Date 2006-06
Est. Completion 2011-08
Phase Phase 1
Valerio Therapeutics

13 total trials

What the finished NCT00413075 record still lists

NCT00413075 is an interventional study that assigns participants to a tested intervention. The registered 121 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (102% higher).

The record links to 0 conditions, and to 1 intervention - of which oral belinostat is the first listed.

NCT00413075 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00413075 about?

NCT00413075 is a clinical study titled "Study of Oral PXD101 in Patients With Advanced Solid Tumors or Lymphoma". 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...

What is the current status of trial NCT00413075?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 121 participants. The study started on 2006-06. Estimated completion is 2011-08.

What interventions are being tested in trial NCT00413075?

The interventions under investigation include: oral belinostat (DRUG).

Who is sponsoring clinical trial NCT00413075?

This trial is sponsored by Valerio Therapeutics, which has 13 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00413075's enrollment target sits among peer trials

121 476th of 2000 higher than 1,522 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.

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Source: ClinicalTrials.gov NCT00413075, the US trial registry maintained by the National Library of Medicine. NCT00413075 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.