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NCT00274651 · ClinicalTrials.gov registry record · Phase 2

A Phase II Clinical Trial of PXD101 in Patients With Recurrent or Refractory Cutaneous and Peripheral T-Cell Lymphomas

A Phase 2 study, sponsored by Valerio Therapeutics.

Terminated
Registry status
Phase 2
Development phase
53
Enrollment target

NCT00274651: Clinical Trial Phase 2 study, sponsored by Valerio Therapeutics.

NCT00274651 is a Phase 2 study that was terminated before completion, run by Valerio Therapeutics. The registered enrollment target is 53 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (60% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00274651, a Phase 2 study, was terminated before completion, sponsored by Valerio Therapeutics.

TERMINATED
Registry status
Phase 2
Development phase
53 participants
Enrollment target

Study Summary

Open-label, non-randomized trial to assess the effectiveness of PXD101 in patients with recurrent or refractory cutaneous or peripheral and other types of T-cell lymphomas. PXD101 is a new, potent histone deacetylase (HDAC) inhibitor. Patients are treated with belinostat(PXD101) 1000 mg/m2 on days 1-5 of a 21 day cycle.

Primary Outcome

Tumor response was assessed using Cheson (Cheson 2007) and SWAT criteria. The SWAT score represents the product of the percentage total body surface area (TBSA) involvement of each lesion type (patch, plaque, and tumor or ulceration), multiplied by a weighting factor.

Interventions

  • DRUG belinostat

Trial Details

FieldValue
Enrollment Target 53 participants
Start Date 2006-01
Est. Completion 2009-07
Phase Phase 2
Valerio Therapeutics

13 total trials

Why NCT00274651 stopped before completion

NCT00274651 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 53 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (60% lower).

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

NCT00274651 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00274651 about?

NCT00274651 is a clinical study titled "A Phase II Clinical Trial of PXD101 in Patients With Recurrent or Refractory Cutaneous and Peripheral T-Cell Lymphomas". Open-label, non-randomized trial to assess the effectiveness of PXD101 in patients with recurrent or refractory cutaneous or peripheral and other types of T-cell lymphomas. PXD101 is a new, potent histone deacetylase (HDAC) inhibitor. Patients are treated with belinostat(PXD101) 1000 mg/m2 on days 1...

What is the current status of trial NCT00274651?

This trial is currently terminated. It is a Phase 2 study. The enrollment target is 53 participants. The study started on 2006-01. Estimated completion is 2009-07.

What interventions are being tested in trial NCT00274651?

The interventions under investigation include: belinostat (DRUG).

Who is sponsoring clinical trial NCT00274651?

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 NCT00274651's enrollment target sits among peer trials

53 1171st of 2000 higher than 820 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 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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Source: ClinicalTrials.gov NCT00274651, the US trial registry maintained by the National Library of Medicine. NCT00274651 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.