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A Phase II, Single-Arm, Open-Label Study To Evaluate The Efficacy, Safety, Pharmacokinetics And Pharmacodynamics Of Idasanutlin Monotherapy In Patients With Hydroxyurea-Resistant/Intolerant Polycythemia Vera

Clinical Trial Details

This is an open-label, single-arm, study of idasanutlin monotherapy in patients with HU-resistant/intolerant PV. 

The primary endpoint in this study is efficacy, based on the inclusion criteria, defined as response at Week 32: 

  • Hct control and 35% reduction or greater in spleen volume in patients with splenomegaly - OR - Hct control in patients without splenomegaly 

Assessments earlier than Week 32, i.e., after Cycles 3 and 5, may enable understanding of whether idasanutlin-driven efficacy is apparent earlier. 

All patients will be treated and assessed according to the Schedule of Activities (SoA) for up to 2 years after the first dose. 

Key Eligibility: 

Documentation that the patient meets the revised 2016 WHO criteria for the diagnosis of polycythemia vera. To verify that the criteria have been met, appropriate laboratory or pathology reports must be submitted during screening demonstrating that the patient has documentation of these diagnostic criteria. These reports do not have to exactly coincide with the original date of diagnosis.

Study contact by location

Upper East Side - Manhattan

Contact(s)

Victoria Mendez
212-746-4829
vib9049@med.cornell.edu

Primary Investigator(s)

Protocol ID(s)

Weill Cornell Medicine IRB #:

1711018755

ClinicalTrials.gov:

NCT03287245

Status

Open to Enrollment

Age Group

Adult

Sponsor