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NCT00375219 · ClinicalTrials.gov registry record · Phase 2

Homoharringtonine (Omacetaxine Mepesuccinate) in Treating Patients With Chronic Myeloid Leukemia (CML) With the T315I BCR-ABL Gene Mutation

A Phase 2 study, sponsored by Teva Branded Pharmaceutical Products R&D.

Completed
Registry status
Phase 2
Development phase
103
Enrollment target

NCT00375219 is a Phase 2 study that has completed, run by Teva Branded Pharmaceutical Products R&D. The registered enrollment target is 103 participants.

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The verdict

NCT00375219, a Phase 2 study, has completed, sponsored by Teva Branded Pharmaceutical Products R&D.

COMPLETED
Registry status
Phase 2
Development phase
103 participants
Enrollment target

Study Summary

To evaluate the safety and efficacy of subcutaneous administration of omacetaxine mepesuccinate (HHT) in achieving a clinical response in CML patients in chronic, accelerated, or blast phase who have failed prior imatinib therapy and have the T315I kinase domain gene mutation.

Interventions

  • DRUG Omacetaxine mepesuccinate

Trial Details

FieldValue
Enrollment Target 103 participants
Start Date 2006-09-20
Est. Completion 2013-06-28
Phase Phase 2

What the Registry Record Tells You About NCT00375219

The ClinicalTrials.gov registry entry for NCT00375219 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 103 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Teva Branded Pharmaceutical Products R&D, which has 167 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which Omacetaxine mepesuccinate is the first listed.

NCT00375219 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00375219 about?

NCT00375219 is a clinical study titled "Homoharringtonine (Omacetaxine Mepesuccinate) in Treating Patients With Chronic Myeloid Leukemia (CML) With the T315I BCR-ABL Gene Mutation". To evaluate the safety and efficacy of subcutaneous administration of omacetaxine mepesuccinate (HHT) in achieving a clinical response in CML patients in chronic, accelerated, or blast phase who have failed prior imatinib therapy and have the T315I kinase domain gene mutation.

What is the current status of trial NCT00375219?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 103 participants. The study started on 2006-09-20. Estimated completion is 2013-06-28.

What interventions are being tested in trial NCT00375219?

The interventions under investigation include: Omacetaxine mepesuccinate (DRUG).

Who is sponsoring clinical trial NCT00375219?

This trial is sponsored by Teva Branded Pharmaceutical Products R&D, which has 167 total clinical trials registered on ClinicalTrials.gov.

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

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