IRB #

STUDY00019290

Title

A Phase 1b Dose-escalation Study to Assess the Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of PLX2853 in Subjects with Relapsed or Refractory Acute Myeloid Leukemia or High-risk Myelodysplastic Syndrome

Principal Investigator

Uma Borate

Study Purpose

This study is being done to answer the following questions: How safe is using PLX2853 (the study drug) in patients with AML and MDS? What is the appropriate dose of the investigational drug to use for further studies?

Medical Condition(s)

Acute Myeloid Leukemia (AML), Myelodysplastic Syndrome (MDS)

Eligibility Criteria

Eligible subjects must meet the following:
-Be at least 18 years or older,
-Have either been diagnosed with AML or MDS and,
-After treatment, your disease has either relapsed (come back) or is refractory (has not responded to treatment)

Age Range

18 - N/A

Healthy Volunteers Needed

No

Duration of Participation

You will receive the study drug for as long as there is clinical benefit (that is your disease does not progress) and you are able to tolerate the study drug. After you finish the study drug, your investigator will continue to watch you for side effects and follow your condition for up to 3 years to assess the status of your disease.

Minors Included

No

Contact

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

Sponsor

Plexxikon Inc.

Recruitment End

01/01/2028

Compensation Provided

No


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