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NCT00005639 · ClinicalTrials.gov registry record · Phase 1

Azacitidine Plus Phenylbutyrate in Treating Patients With Advanced or Metastatic Solid Tumors That Have Not Responded to Previous Treatment

A Phase 1 study, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.

Completed
Registry status
Phase 1
Development phase
34
Enrollment target

NCT00005639: Completed Phase 1 study, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.

NCT00005639 is a Phase 1 study that has completed, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins. The registered enrollment target is 34 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (43% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00005639, a Phase 1 study, has completed, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.

COMPLETED
Registry status
Phase 1
Development phase
34 participants
Enrollment target

Study Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: This phase I trial is studying the side effects and best dose of azacitidine plus phenylbutyrate in treating patients with advanced or metastatic solid tumors that have not responded to previous treatment.

Primary Outcome

MED (milligrams) of combined Azacitidine and Phenylbutyrate that results in clinical response, as defined by Standard World Health Organization (WHO) criteria and/or target inhibition.

Interventions

  • DRUG Azacitidine Injection
  • DRUG sodium phenylbutyrate

Trial Details

FieldValue
Enrollment Target 34 participants
Start Date 2000-03
Est. Completion 2005-07
Phase Phase 1

What the finished NCT00005639 record still lists

NCT00005639 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 34 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (43% lower).

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

NCT00005639 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00005639 about?

NCT00005639 is a clinical study titled "Azacitidine Plus Phenylbutyrate in Treating Patients With Advanced or Metastatic Solid Tumors That Have Not Responded to Previous Treatment". RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: This phase I trial is studying the side effects and best dose of azacitidine plus phenylbutyrate in treating patie...

What is the current status of trial NCT00005639?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 34 participants. The study started on 2000-03. Estimated completion is 2005-07.

What interventions are being tested in trial NCT00005639?

The interventions under investigation include: Azacitidine Injection (DRUG), sodium phenylbutyrate (DRUG).

Who is sponsoring clinical trial NCT00005639?

This trial is sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, which has 523 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00005639's enrollment target sits among peer trials

34 1273rd of 2000 higher than 721 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 NCT00005639, the US trial registry maintained by the National Library of Medicine. NCT00005639 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.