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

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ClinicalTrials.gov Identifier: NCT03123588
Recruitment Status : Recruiting
First Posted : April 21, 2017
Last Update Posted : August 1, 2018
Sponsor:
Information provided by (Responsible Party):
Incyte Corporation

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
MPN (Myeloproliferative Neoplasms) Drug: Ruxolitinib Drug: Anagrelide Drug: Placebo Phase 2

Expanded Access : An investigational treatment associated with this study is available outside the clinical trial.   More info ...

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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)
Actual Study Start Date : April 20, 2017
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : June 2020


Arm Intervention/treatment
Experimental: Ruxolitinib Drug: Ruxolitinib
Ruxolitinib administered orally twice daily (BID) at the protocol-defined starting dose.
Other Names:
  • Jakafi
  • INCB018424

Drug: Placebo
Anagrelide-placebo administered orally BID

Active Comparator: Anagrelide Drug: Anagrelide
Anagrelide administered orally at a starting dose of 1 mg BID.

Drug: Placebo
Ruxolitinib-placebo administered orally BID.




Primary Outcome Measures :
  1. Efficacy of ruxolitinib versus anagrelide as measured by proportion of subjects who achieve platelet and white blood cell (WBC) control [ Time Frame: 52 weeks ]

Secondary Outcome Measures :
  1. Safety and tolerability of ruxolitinib measured by adverse events [ Time Frame: Baseline through 30-37 days after end of treatment, up to 36 months per subject. ]
  2. Proportion of subjects who achieve complete remission or partial remission based on European LeukemiaNet (ELN) 2013 response criteria [ Time Frame: 32 weeks ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03123588


Contacts
Contact: Incyte Corporation Call Center 1.855.463.3463 medinfo@incyte.com

  Show 49 Study Locations
Sponsors and Collaborators
Incyte Corporation
Investigators
Study Director: Albert Assad, MD Incyte Corporation

Responsible Party: Incyte Corporation
ClinicalTrials.gov Identifier: NCT03123588     History of Changes
Other Study ID Numbers: INCB 18424-272 (RESET-272)
First Posted: April 21, 2017    Key Record Dates
Last Update Posted: August 1, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Incyte Corporation:
Essential thrombocythemia
hydroxyurea-resistant
hydroxyurea-intolerant
ruxolitinib
anagrelide

Additional relevant MeSH terms:
Myeloproliferative Disorders
Thrombocytosis
Thrombocythemia, Essential
Bone Marrow Diseases
Hematologic Diseases
Blood Platelet Disorders
Blood Coagulation Disorders
Hemorrhagic Disorders
Hydroxyurea
Anagrelide
Antineoplastic Agents
Antisickling Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Fibrinolytic Agents
Fibrin Modulating Agents
Platelet Aggregation Inhibitors