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NCT00389480 · ClinicalTrials.gov registry record · Phase 1

Study of AR-67 (Formerly DB-67) in Adult Patients With Refractory or Metastatic Solid Malignancies

A Phase 1 study, sponsored by Arno Therapeutics.

Completed
Registry status
Phase 1
Development phase
26
Enrollment target

NCT00389480 is a Phase 1 study that has completed, run by Arno Therapeutics. The registered enrollment target is 26 participants.

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The verdict

NCT00389480, a Phase 1 study, has completed, sponsored by Arno Therapeutics.

COMPLETED
Registry status
Phase 1
Development phase
26 participants
Enrollment target

Study Summary

Hypothesis: AR-67 (formerly DB-67) represents a rationally engineered drug that possesses improved stability, toxicity, and efficacy compared to current Food and Drug Administration (FDA)-approved camptothecins, based on the extensive research of prior studies. Therefore, the investigators hypothesize that AR-67 (formerly DB-67) will be well-tolerated and efficacious in phase I clinical trials. This initial phase I trial will establish the maximum tolerated dose in humans, establish the toxicity profile, and define the appropriate dose of AR-67 (formerly DB-67) for future phase II and III clinical trials.

Interventions

  • DRUG AR-67 (formerly DB-67)

Trial Details

FieldValue
Enrollment Target 26 participants
Start Date 2006-10
Est. Completion 2009-05
Phase Phase 1

Sponsor

Arno Therapeutics

2 total trials

What the Registry Record Tells You About NCT00389480

The ClinicalTrials.gov registry entry for NCT00389480 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 26 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Arno Therapeutics, which has 2 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which AR-67 (formerly DB-67) is the first listed.

NCT00389480 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00389480 about?

NCT00389480 is a clinical study titled "Study of AR-67 (Formerly DB-67) in Adult Patients With Refractory or Metastatic Solid Malignancies". Hypothesis: AR-67 (formerly DB-67) represents a rationally engineered drug that possesses improved stability, toxicity, and efficacy compared to current Food and Drug Administration (FDA)-approved camptothecins, based on the extensive research of prior studies. Therefore, the investigators hypothes...

What is the current status of trial NCT00389480?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 26 participants. The study started on 2006-10. Estimated completion is 2009-05.

What interventions are being tested in trial NCT00389480?

The interventions under investigation include: AR-67 (formerly DB-67) (DRUG).

Who is sponsoring clinical trial NCT00389480?

This trial is sponsored by Arno Therapeutics, which has 2 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.