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NCT00520208 · ClinicalTrials.gov registry record · Phase 2

Safety, Efficacy, & Pharmacokinetic Study of Tamibarotene to Treat Patients With Relapsed or Refractory APL

A Phase 2 study of Acute Promyelocytic Leukemia, sponsored by CytRx.

Completed
Registry status
Phase 2
Development phase
15
Enrollment target
2
Study locations

NCT00520208 is a Phase 2 study of Acute Promyelocytic Leukemia that has completed, run by CytRx. The registered enrollment target is 15 participants. The trial reports 2 study locations across 2 states.

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The verdict

NCT00520208, a Phase 2 study of Acute Promyelocytic Leukemia, has completed, sponsored by CytRx.

COMPLETED
Registry status
Phase 2
Development phase
15 participants
Enrollment target
2
Study locations

Study Summary

This is a Phase II, open-label, non-randomized study to evaluate the safety, efficacy, and pharmacokinetics of tamibarotene in adult patients with relapsed or refractory acute promyelocytic leukemia (APL) following treatment with all-trans-retinoic acid (ATRA) and arsenic trioxide (ATO). Patients must have received and failed therapy with ATRA and ATO. Treatment may have been administered either as combination therapy or sequentially as single agents. Patients who are intolerant to either drug are eligible for this study.

Interventions

  • DRUG Tamibarotene

Study Locations (2)

Illinois

  • Northwestern University - Chicago

Texas

  • UT MD Anderson Cancer Center - Houston

Trial Details

FieldValue
Enrollment Target 15 participants
Start Date 2007-09
Est. Completion 2013-01
Phase Phase 2

Sponsor

CytRx

6 total trials

What the Registry Record Tells You About NCT00520208

The ClinicalTrials.gov registry entry for NCT00520208 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 15 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is CytRx, which has 6 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Acute Promyelocytic Leukemia appearing as the primary indexed condition, and to 1 intervention - of which Tamibarotene is the first listed.

NCT00520208 reports 2 study locations spanning 2 distinct geographic areas - top geographies include Illinois, Texas.

Frequently Asked Questions

What is clinical trial NCT00520208 about?

NCT00520208 is a clinical study titled "Safety, Efficacy, & Pharmacokinetic Study of Tamibarotene to Treat Patients With Relapsed or Refractory APL". This is a Phase II, open-label, non-randomized study to evaluate the safety, efficacy, and pharmacokinetics of tamibarotene in adult patients with relapsed or refractory acute promyelocytic leukemia (APL) following treatment with all-trans-retinoic acid (ATRA) and arsenic trioxide (ATO). Patients mu...

What is the current status of trial NCT00520208?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 15 participants. The study started on 2007-09. Estimated completion is 2013-01.

What conditions does trial NCT00520208 study?

This clinical trial studies the following conditions: Acute Promyelocytic Leukemia.

What interventions are being tested in trial NCT00520208?

The interventions under investigation include: Tamibarotene (DRUG).

Who is sponsoring clinical trial NCT00520208?

This trial is sponsored by CytRx, which has 6 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00520208 being conducted?

This trial has 2 study locations across Illinois, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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

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