Phase 2 Study of Ruxolitinib Versus Anagrelide in Subjects With Essential Thrombocythemia Who Are Resistant to or Intolerant of Hydroxyurea (RESET-272)
NCT ID: NCT03123588
Last Updated: 2021-11-19
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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TERMINATED
PHASE2
12 participants
INTERVENTIONAL
2017-11-14
2020-08-03
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Group A : Ruxolitinib and anagrelide placebo
Ruxolitinib or placebo will be administered orally twice a day at a starting dose of 10 mg.
Ruxolitinib
Ruxolitinib administered orally twice daily (BID) at the protocol-defined starting dose.
Placebo
Anagrelide-placebo administered orally BID
Group B : Anagrelide and Ruxolitinib PLacebo
Anagrelide or placebo will be administered orally twice a day at a starting dose of 1 mg. Use of anagrelide will be consistent with approved prescribing information.
Anagrelide
Anagrelide administered orally at a starting dose of 1 mg BID.
Placebo
Ruxolitinib-placebo administered orally BID.
Interventions
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Ruxolitinib
Ruxolitinib administered orally twice daily (BID) at the protocol-defined starting dose.
Anagrelide
Anagrelide administered orally at a starting dose of 1 mg BID.
Placebo
Anagrelide-placebo administered orally BID
Placebo
Ruxolitinib-placebo administered orally BID.
Other Intervention Names
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Eligibility Criteria
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Inclusion 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.
* 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.
Exclusion Criteria
1. 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).
18 Years
ALL
No
Sponsors
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Incyte Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Albert Assad, MD
Role: STUDY_DIRECTOR
Incyte Corporation
Locations
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Mayo Clinic
Phoenix, Arizona, United States
Pacific Shores Medical Group
Long Beach, California, United States
University of Southern California
Los Angeles, California, United States
Ventura County Hematology-Oncology Specialists
Oxnard, California, United States
Compassionate Cancer Care Medical Group
Riverside, California, United States
Innovative Clinical Research Institute
Whittier, California, United States
Bond Clinic, PA
Winter Haven, Florida, United States
Tift Regional
Tifton, Georgia, United States
Edward Cancer Center
Naperville, Illinois, United States
North Shore Cancer Research Association-Skokie
Skokie, Illinois, United States
Southern Illinois University
Springfield, Illinois, United States
Clinical Trials of SWLA LLC
Lake Charles, Louisiana, United States
St. Agnes Hospital
Baltimore, Maryland, United States
Washington University School of Medicine
St Louis, Missouri, United States
Summit Medical Group
Morristown, New Jersey, United States
Columbia Weill Cornell Cancer Centers - Herbert Irving Comprehensive Cancer Center (HICCC)
New York, New York, United States
Montefiore Medical Center
The Bronx, New York, United States
Waverly Hem Onc
Cary, North Carolina, United States
Vidant Medical Center
Greenville, North Carolina, United States
Gabrail Cancer Center- Canton Facility
Canton, Ohio, United States
INTEGRIS Southwest Medical Center
Oklahoma City, Oklahoma, United States
INTEGRIS Cancer Institute Proton Campus
Oklahoma City, Oklahoma, United States
Kaiser Permanente Northwest
Portland, Oregon, United States
Geisinger - Knapper Clinic
Danville, Pennsylvania, United States
Prairie Lakes Health Care System Inc.
Watertown, South Dakota, United States
Renovatio Clinical
The Woodlands, Texas, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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INCB 18424-272 (RESET-272)
Identifier Type: -
Identifier Source: org_study_id