Phase 2 Study of Ruxolitinib Versus Anagrelide in Subjects With Essential Thrombocythemia Who Are Resistant to or Intolerant of Hydroxyurea (RESET-272)



Status:Recruiting
Conditions:Hematology
Therapuetic Areas:Hematology
Healthy:No
Age Range:18 - Any
Updated:12/8/2018
Start Date:April 20, 2017
End Date:June 2020
Contact:Incyte Corporation Call Center
Email:medinfo@incyte.com
Phone:1.855.463.3463

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A Double-Blind, Double-Dummy Phase 2 Randomized Study to Evaluate the Efficacy and Safety of Ruxolitinib Versus Anagrelide in Subjects With Essential Thrombocythemia Who Are Resistant to or Intolerant of Hydroxyurea (RESET-272)

The purpose of this study is to evaluate the efficacy and safety of ruxolitinib versus
anagrelide in subjects with essential thrombocythemia who are resistant to or intolerant of
hydroxyurea.


Inclusion Criteria:

- Diagnosis of essential thrombocythemia according to revised World Health Organization
(WHO) 2016 criteria.

- Resistant to or intolerant of hydroxyurea, that is, fulfilling at least 1 of the
following criteria:

- Platelet count > 600 × 10^9/L after 3 months of at least 2 g/day of hydroxyurea
(2.5 g/day in subjects with a body weight over 80 kg) OR at the subject's
maximally tolerated dose if that dose is < 2 g/day.

- Platelet count > 400 × 10^9/L and WBC count < 2.5 × 10^9/L or hemoglobin < 10
g/dL at any dose of hydroxyurea.

- Presence of leg ulcers or other unacceptable mucocutaneous manifestations at any
dose of hydroxyurea.

- Hydroxyurea-related fever.

- Platelet count > 650 × 10^9/L at screening.

- WBC > 11.0 × 10^9/L at screening.

Exclusion Criteria:

- Subjects previously treated with anagrelide or JAK inhibitors.

- Inadequate liver function at screening and Day 1 (before drug administration) as
demonstrated by:

- Total bilirubin > 1.5 × upper limit of normal (ULN)

- Aspartate aminotransferase or alanine aminotransferase > 1.5 × ULN

- Hepatocellular disease (eg, cirrhosis)

- Inadequate renal function at screening as demonstrated by creatinine clearance < 40
mL/min calculated by Cockcroft-Gault equation.
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