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

Information source: Incyte Corporation
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Polycythemia Vera; Essential Thrombocythemia

Intervention: Ruxolitinib (Drug)

Phase: Phase 2

Status: Active, not recruiting

Sponsored by: Incyte Corporation

Official(s) and/or principal investigator(s):
Lance Leopold, MD, Study Director, Affiliation: Incyte Corporation

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 will be refractory to hydroxyurea or for whom hydroxyurea is contraindicated.

Clinical Details

Official title: An Open-Label Study to Determine the Safety and Efficacy of INCB018424 in Patients With Advanced Polycythemia Vera or Essential Thrombocythemia Refractory to Hydroxyurea

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

Percentage of Polycythemia Vera Participants With a Confirmed Clinical Partial Response (PR) or Complete Response (CR)

Percentage of Essential Thrombocythemia (ET) Participants With a Confirmed Clinical Partial Response (PR) or Complete Response (CR)

Secondary outcome:

Percentage of Polycythemia Vera Participants Who Achieved Individual Components of Clinical Response at 12 Weeks

Percentage of Polycythemia Vera Participants Who Achieved Individual Components of Clinical Response at 24 Weeks

Percentage of Polycythemia Vera Participants Who Achieved Individual Components of Clinical Response at 36 Weeks

Percentage of Essential Thrombocythemia Participants Who Achieved Individual Components of Clinical Response at 4 Weeks

Percentage of Essential Thrombocythemia Participants Who Achieved Individual Components of Clinical Response at 24 Weeks

Percentage of Essential Thrombocythemia Participants Who Achieved Individual Components of Clinical Response at 36 Weeks

Change From Baseline to Week 4 in Polycythemia Vera Symptoms

Change From Baseline to Week 4 in Essential Thrombocythemia Symptoms

Change From Baseline to Week 4 in Health-related Quality of Life

Detailed description: The study consisted of a 2-stage design, which included a dose-ranging phase (during which patients received treatment at their randomized dose) and an expansion phase (after adjustment of dose/regimen to achieve an optimal balance of efficacy and safety). During the dose-ranging phase, patients in each disease group (PV or ET) were randomly assigned in a 1: 1:1 ratio independent of each other to receive 1 of 3 treatment regimens with Ruxolitinib, 10 mg twice daily (bid), 25 mg bid, or 50 mg once daily (qd). After patients completed 2 cycles of treatment with Ruxolitinib at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis using their discretion in order to achieve an optimal balance of efficacy and safety. During the expansion phase (ie, after optimization of dose), additional patients with PV or ET were enrolled to receive Ruxolitinib at the dose that was selected upon review of data from the dose-ranging phase. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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)

Locations and Contacts

Bergamo, Italy

Firenze, Italy

Pavia, Italy

Houston, Texas 77030, United States

Additional Information

Starting date: July 2008
Last updated: March 26, 2015

Page last updated: August 23, 2015

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