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NCT01522469 · ClinicalTrials.gov registry record · Phase 2

Phase II Study of Crenolanib in Subjects With Relapsed/Refractory AML With FLT3 Activating Mutations

A Phase 2 study, sponsored by Arog Pharmaceuticals.

Completed
Registry status
Phase 2
Development phase
14
Enrollment target

NCT01522469 is a Phase 2 study that has completed, run by Arog Pharmaceuticals. The registered enrollment target is 14 participants.

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The verdict

NCT01522469, a Phase 2 study, has completed, sponsored by Arog Pharmaceuticals.

COMPLETED
Registry status
Phase 2
Development phase
14 participants
Enrollment target

Study Summary

This is a Phase II open label study of crenolanib besylate. This study will enroll subjects with relapsed or refractory AML with FLT3 activating mutations. Prior treatment with other FLT3 TKIs is allowed. Subjects will take crenolanib 200mg/m2/day divided in three doses daily (preferably every eight hours), taken orally at least 30 minutes pre or post meal until disease progression, death, or the patient discontinues treatment for adverse events, investigator's judgment, or other reasons. Patients who are able to proceed to allogeneic stem cell transplant will be able to resume crenolanib therapy post-transplant in an attempt to maintain remission.

Interventions

  • DRUG Crenolanib Besylate (CP-868,596-26)

Trial Details

FieldValue
Enrollment Target 14 participants
Start Date 2012-07
Est. Completion 2014-11
Phase Phase 2

Sponsor

Arog Pharmaceuticals

13 total trials

What the Registry Record Tells You About NCT01522469

The ClinicalTrials.gov registry entry for NCT01522469 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 14 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Arog Pharmaceuticals, which has 13 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which Crenolanib Besylate (CP-868,596-26) is the first listed.

NCT01522469 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT01522469 about?

NCT01522469 is a clinical study titled "Phase II Study of Crenolanib in Subjects With Relapsed/Refractory AML With FLT3 Activating Mutations". This is a Phase II open label study of crenolanib besylate. This study will enroll subjects with relapsed or refractory AML with FLT3 activating mutations. Prior treatment with other FLT3 TKIs is allowed. Subjects will take crenolanib 200mg/m2/day divided in three doses daily (preferably every eight...

What is the current status of trial NCT01522469?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 14 participants. The study started on 2012-07. Estimated completion is 2014-11.

What interventions are being tested in trial NCT01522469?

The interventions under investigation include: Crenolanib Besylate (CP-868,596-26) (DRUG).

Who is sponsoring clinical trial NCT01522469?

This trial is sponsored by Arog Pharmaceuticals, 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.