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NCT00131261 · ClinicalTrials.gov registry record · Phase 2

Clinical Trial of PXD101 in Patients With Advanced Multiple Myeloma

A Phase 2 study, sponsored by Valerio Therapeutics.

Completed
Registry status
Phase 2
Development phase
25
Enrollment target

NCT00131261 is a Phase 2 study that has completed, run by Valerio Therapeutics. The registered enrollment target is 25 participants.

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The verdict

NCT00131261, a Phase 2 study, has completed, sponsored by Valerio Therapeutics.

COMPLETED
Registry status
Phase 2
Development phase
25 participants
Enrollment target

Study Summary

The purpose of this open-label, non-randomized trial is to assess the safety and effectiveness of PXD101, both alone and in combination with dexamethasone, in patients with advanced multiple myeloma. PXD101 is a new, potent histone deacetylase (HDAC) inhibitor. Various members of this class of drugs have shown activity in preclinical studies and in initial clinical trials of multiple myeloma and lymphoma. Furthermore, HDAC inhibitors, including PXD101, have been shown to sensitize myeloma cells to the killing effect of other chemotherapeutic agents, including dexamethasone, a well-established agent in relapsing myeloma.

Interventions

  • DRUG Dexamethasone
  • DRUG PXD101

Trial Details

FieldValue
Enrollment Target 25 participants
Start Date 2005-01
Est. Completion 2007-06
Phase Phase 2

Sponsor

Valerio Therapeutics

13 total trials

What the Registry Record Tells You About NCT00131261

The ClinicalTrials.gov registry entry for NCT00131261 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 25 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Valerio Therapeutics, which has 13 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which Dexamethasone is the first listed.

NCT00131261 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00131261 about?

NCT00131261 is a clinical study titled "Clinical Trial of PXD101 in Patients With Advanced Multiple Myeloma". The purpose of this open-label, non-randomized trial is to assess the safety and effectiveness of PXD101, both alone and in combination with dexamethasone, in patients with advanced multiple myeloma. PXD101 is a new, potent histone deacetylase (HDAC) inhibitor. Various members of this class of drugs...

What is the current status of trial NCT00131261?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 25 participants. The study started on 2005-01. Estimated completion is 2007-06.

What interventions are being tested in trial NCT00131261?

The interventions under investigation include: Dexamethasone (DRUG), PXD101 (DRUG).

Who is sponsoring clinical trial NCT00131261?

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

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.