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Trial record 1 of 1 for:    NCT03123588
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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)

This study is currently recruiting participants.
See Contacts and Locations
Verified August 2017 by Incyte Corporation
Sponsor:
Information provided by (Responsible Party):
Incyte Corporation
ClinicalTrials.gov Identifier:
NCT03123588
First received: April 17, 2017
Last updated: August 15, 2017
Last verified: August 2017
  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.

Condition Intervention Phase
Essential Thrombocythemia Drug: Ruxolitinib Drug: Anagrelide Drug: Placebo Phase 2

Access to an investigational treatment associated with this study is available outside the clinical trial.   More info ...

Study Type: Interventional
Study Design: 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)

Resource links provided by NLM:


Further study details as provided by Incyte Corporation:

Primary Outcome Measures:
  • 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:
  • 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. ]
  • Proportion of subjects who achieve complete remission or partial remission based on European LeukemiaNet (ELN) 2013 response criteria [ Time Frame: 32 weeks ]

Estimated Enrollment: 120
Actual Study Start Date: April 20, 2017
Estimated Study Completion Date: June 2020
Estimated Primary Completion Date: May 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03123588

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

Locations
United States, California
Ventura County Hematology-Oncology Specialists Recruiting
Oxnard, California, United States, 93030
Contact: Study Coordinator    805-485-8709 ext 129      
Redlands Community Hospital Recruiting
Redlands, California, United States, 92373
Contact: Study Coordinator    909-478-7973      
Innovative Clinical Research Institute Recruiting
Whittier, California, United States, 90603
Contact: Marusa Obele    562-693-4477      
United States, Florida
Mid Florida Hematology and Oncolcogy Center Recruiting
Orange City, Florida, United States, 32763
Contact: Ashby Rina    386-774-1223 ext 119      
Boca Raton Clinical Research Recruiting
Plantation, Florida, United States, 33322
Contact: Gabriella Coletta    561-447-0614      
Bond Clinic, PA Recruiting
Winter Haven, Florida, United States, 33880
Contact: Nikki Denmark    863-293-1191 ext 3391      
United States, Illinois
North Shore Cancer Research Association-Skokie Recruiting
Skokie, Illinois, United States, 60070
Contact: Marsha Weller    847-675-3900      
United States, Louisiana
Clinical Trials of SWLA LLC Recruiting
Lake Charles, Louisiana, United States, 70601
Contact: Jami Gardner    337-602-6642      
United States, Maryland
St. Agnes Hospital Recruiting
Baltimore, Maryland, United States, 21229
Contact: Elizabeth Chandler    667-234-2966      
United States, New Jersey
Summit Medical Group Recruiting
Morristown, New Jersey, United States, 07960
Contact: Michelle MacKenzie    973-436-1755      
United States, North Carolina
Waverly Hem Onc Recruiting
Cary, North Carolina, United States, 27518
Contact: Gena Boyd    919-223-8585 ext 111      
United States, Ohio
Gabrail Cancer Center- Canton Facility Recruiting
Canton, Ohio, United States, 44718
Contact: Kristie Armstron    330-492-3345 ext 209      
Cleveland Clinic Recruiting
Cleveland, Ohio, United States, 44195
Contact: Study Coordinator    216-445-0003      
United States, Texas
Renovatio Clinical Recruiting
The Woodlands, Texas, United States, 77401
Contact: Study Coordinator    713-703-2398      
Sponsors and Collaborators
Incyte Corporation
Investigators
Study Director: Albert Assad, MD Incyte Corporation
  More Information

Responsible Party: Incyte Corporation
ClinicalTrials.gov Identifier: NCT03123588     History of Changes
Other Study ID Numbers: INCB 18424-272 (RESET-272)
Study First Received: April 17, 2017
Last Updated: August 15, 2017
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:
Thrombocytosis
Thrombocythemia, Essential
Blood Platelet Disorders
Hematologic Diseases
Myeloproliferative Disorders
Bone Marrow Diseases
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

ClinicalTrials.gov processed this record on August 18, 2017