Myeloproliferative neoplasms (MPN)

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

Incyte Study ID:
INCB 18424-272 (RESET-272)
CT.gov ID:
NCT03123588
Eudra ID:
N/A
EU CT Number:
N/A
Sponsor:
Incyte Corporation
Collaborator:
N/A
Study Contact Information:
1.855.463.3463 or [email protected]
Other
Subscribe to UpdatesContact Us

Results Available

Protocol
Available Languages: English
Download document(s)
Statistical Analysis Plan (SAP)
Available Languages: English
Download document(s)

Clinical Study Purpose

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.

Clinical Study Summary

MEDICAL CONDITION(S)
  • Myeloproliferative neoplasms (MPN)
    • PRODUCT
  • Drug: Ruxolitinib
  • Drug: Anagrelide
  • Drug: Placebo
    • COLLABORATORS
    N/A
    DATE
    Nov 2017 - Aug 2020
    TYPE
    Interventional
    PHASE
    Phase 2
    SEX
    Female & Male
    AGE
    18+ years
    ACCEPTS HEALTHY VOLUNTEERS
    No

    Clinical Study Locations

    Name
    Contact Us
    Name
    Mayo Clinic
    Phoenix, Arizona, US, 85054
    Name
    Pacific Shores Medical Group
    Long Beach, California, US, 90813
    Name
    UCLA Healthcare Hematology-Oncology
    Los Angeles, California, US, 90095
    Name
    University of Southern California
    Los Angeles, California, US, 90033
    Name
    Ventura County Hematology-Oncology Specialists
    Oxnard, California, US, 93030
    Name
    Redlands Community Hospital
    Redlands, California, US, 92373
    Go to page

    Key Inclusion and Exclusion 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:

    Exclusion Criteria

    • Subjects previously treated with anagrelide or Hydroxyurea (HU).
    • a. Prior anagrelide use is allowed provided the reason for discontinuation is not AE‑related and anagrelide is stopped at least 28 days before the start of study medications (ie, Day 1).
    Requirements information
    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 Hydroxyurea (HU).
    • a. Prior anagrelide use is allowed provided the reason for discontinuation is not AE‑related and anagrelide is stopped at least 28 days before the start of study medications (ie, Day 1).
    • b. Treatment with HU can be stopped at any time once one of the inclusion criteria for HU refractoriness or resistance have been met, and up to the day before the first dose of study treatment (ie, Day 1).
    • • 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.

    Protocol Summary

    Incyte Study ID:
    INCB 18424-272 (RESET-272)
    Primary Purpose:
    Treatment
    Allocation:
    Randomized
    Study Design:
    Parallel Assignment
    Masking:
    Double (Participant, Investigator)
    Interventions:
  • Drug: Ruxolitinib
  • Drug: Anagrelide
  • Drug: Placebo
    • Enrollment:
    12
    Primary Outcome
    Open

    Proportion of subjects who achieve platelet and white blood cell (WBC) control

    Timeframe: 52 weeks

    Secondary Outcome
    Open

    Number of Treatment Emergent Adverse Events (TEAEs0

    Timeframe: Baseline through 30-37 days after end of treatment, up to 36 months per subject.

    Proportion of subjects who achieve complete remission or partial remission

    Timeframe: 32 weeks

    Time to treatment discontinuation

    Timeframe: 52 weeks

    Duration of response

    Timeframe: 52 weeks

    Proportion of subjects who achieve reduction of platelet counts to < 600 × 109/L

    Timeframe: 52 weeks

    Proportion of subjects who achieve a reduction of WBC counts to < 10 × 109/L

    Timeframe: 52 weeks