IRB #

STUDY00015085

Title

A Randomized, Open-label, Phase 2 Trial of Ponatinib in
Patients with Resistant Chronic Phase Chronic Myeloid
Leukemia to Characterize the Efficacy and Safety of a Range of
Doses

Principal Investigator

Michael Heinrich

Study Purpose

The purpose of this study is to compare any good and bad effects of different starting doses of ponatinib, also called AP24534 or Iclusig, (the “study drug”), to determine which dose provides the best control of Chronic Phase Chronic Myeloid Leukemia (CP-CML) with the least amount of side effects. The use of the study drug could improve the status of your cancer, but it could also cause side effects. This study will allow the researchers to know whether this different approach is better, the same, or worse than the usual approach. To be better, the study drug should decrease the amount of detectable cancer in your blood.

Medical Condition(s)

Chronic Myeloid Leukemia (CML)
Chronic Phase

Eligibility Criteria

To be eligible, you must have chronic phase Chronic Myeloid Leukemia (CP-CML). You must have already been treated with at least two tyrosine kinase inhibitors (TKIs) and your disease is not responding.

Age Range

18 - 120

Healthy Volunteers Needed

No

Duration of Participation

The duration of the trial will be 24 months. You will undergo screening tests for up to 3 weeks prior to treatment to determine if you meet the criteria to participate in this trial. The length of time you will take ponatinib will depend on your cancer status (if you benefit from treatment) and how well you tolerate ponatinib.

Minors Included

No

Contact

Knight Clinical Trial Information Line
Phone: 503-494-1080
Email: trials@ohsu.edu

Sponsor

ARIAD Pharmaceuticals, Inc.

Recruitment End

01/01/2030

Compensation Provided

No


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