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NCT00413322 · ClinicalTrials.gov registry record · Phase 1

Study of PXD101 Alone and in Combination With 5-Fluorouracil (5-FU) in Patients With Advanced Solid Tumors

A Phase 1 study, sponsored by Valerio Therapeutics.

Completed
Registry status
Phase 1
Development phase
35
Enrollment target

NCT00413322: Completed Phase 1 study, sponsored by Valerio Therapeutics.

NCT00413322 is a Phase 1 study that has completed, run by Valerio Therapeutics. The registered enrollment target is 35 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (42% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00413322, a Phase 1 study, has completed, sponsored by Valerio Therapeutics.

COMPLETED
Registry status
Phase 1
Development phase
35 participants
Enrollment target

Study Summary

This is a study to assess the combination of PXD101 and 5-Fluorouracil (5-FU)in patients with advanced solid tumors. The primary goal of the study is to understand the safety, anti-tumor activity, and how the study drug behaves within the body when given with 5-Fluorouracil (5-FU).

Interventions

  • DRUG 5-Fluorouracil (5-FU)
  • DRUG belinostat

Trial Details

FieldValue
Enrollment Target 35 participants
Start Date 2005-09
Est. Completion 2008-06
Phase Phase 1
Valerio Therapeutics

13 total trials

What the finished NCT00413322 record still lists

NCT00413322 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 35 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (42% lower).

The record links to 0 conditions, and to 2 interventions - of which 5-Fluorouracil (5-FU) is the first listed.

NCT00413322 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00413322 about?

NCT00413322 is a clinical study titled "Study of PXD101 Alone and in Combination With 5-Fluorouracil (5-FU) in Patients With Advanced Solid Tumors". This is a study to assess the combination of PXD101 and 5-Fluorouracil (5-FU)in patients with advanced solid tumors. The primary goal of the study is to understand the safety, anti-tumor activity, and how the study drug behaves within the body when given with 5-Fluorouracil (5-FU).

What is the current status of trial NCT00413322?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 35 participants. The study started on 2005-09. Estimated completion is 2008-06.

What interventions are being tested in trial NCT00413322?

The interventions under investigation include: 5-Fluorouracil (5-FU) (DRUG), belinostat (DRUG).

Who is sponsoring clinical trial NCT00413322?

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 NCT00413322's enrollment target sits among peer trials

35 1258th of 2000 higher than 728 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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Source: ClinicalTrials.gov NCT00413322, the US trial registry maintained by the National Library of Medicine. NCT00413322 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.