Study to Determine the Safety and Efficacy of INCB018424 in Patients With Polycythemia Vera or Essential Thrombocythemia

• Status: Terminated
• Trial end date: 2018-08-20
• Target enrollment: 0
• Participant gender: All

Summary

To evaluate the safety and efficacy profile of different treatment regimens of Ruxolitinib (INCB018424) administered to two groups of patients; those with polycythemia vera (PV) and those with essential thrombocythemia (ET). Patients in each group were refractory to hydroxyurea or for whom hydroxyurea is contraindicated.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Incyte Corporation

Criteria

Inclusion Criteria:

• Confirmed diagnosis of polycythemia vera or essential thrombocythemia as determined by treating physician

• Disease refractory to hydroxyurea or for whom treatment with hydroxyurea is contraindicated or have refused further treatment with hydroxyurea due to side effects.

• Patient meets baseline clinical lab parameters

Exclusion Criteria:

• Treatment with interferon alpha or anagrelide within 7 days and hydroxyurea within 1 day of starting INCB018424.

• Patients diagnosed with another malignancy unless the malignancy was cervical intraepithelial neoplasia or basal or squamous cell skin cancer and the patient has been disease free for > 3 years

• Patients receiving therapy with intermediate or high dose steroids greater than the equivalent of 10 mg prednisone per day

• Clinically significant cardiac disease (New York Heart Association (NYHA) Class III or IV)