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

Description

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.

Study Start Date

April, 20 2017

Estimated Completion Date

June 2020

Interventions

  • Drug: Placebo
  • Drug: Ruxolitinib
  • Drug: Anagrelide

Study ID

Incyte Corporation -- INCB 18424-272 (RESET-272)

Status

Recruiting

Trial ID

NCT03123588

Study Type

Interventional

Trial Phase

Phase 2

Enrollment Quota

120

Sponsor

Incyte Corporation

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.

Gender

All

Ages

18 Years and older

Accepts Healthy Volunteers

No

Study Locations and Contact Information (109)

Study Location Distance Name Phone Email
Massachusetts General Hospital Cancer Center - Boston, Massachusetts 2.8 miles Study Coordinator 617-726-8033 None
Massachusetts General Hospital Cancer Center - Boston, Massachusetts 2.8 miles Study Coordinator 617-726-8033 None
Montefiore Medical Center - New York, New York 176.6 miles Study Coordinator 718-920-4137 None
Columbia Weill Cornell Cancer Centers Herbert Irving Comprehensive Cancer Center HICCC - New York, New York 181.2 miles Study Coordinator 606-317-5199 None
Columbia Weill Cornell Cancer Centers Herbert Irving Comprehensive Cancer Center HICCC - New York, New York 181.2 miles Study Coordinator 606-317-5199 None
Columbia Weill Cornell Cancer Centers Herbert Irving Comprehensive Cancer Center HICCC - New York, New York 181.2 miles Study Coordinator 606-317-5199 None
Columbia Weill Cornell Cancer Centers Herbert Irving Comprehensive Cancer Center HICCC - New York, New York 181.2 miles Study Coordinator 606-317-5199 None
Columbia Weill Cornell Cancer Centers Herbert Irving Comprehensive Cancer Center HICCC - New York, New York 181.2 miles Study Coordinator 606-317-5199 None
Columbia Weill Cornell Cancer Centers Herbert Irving Comprehensive Cancer Center HICCC - New York, New York 181.2 miles Study Coordinator 606-317-5199 None
Summit Medical Group - Morristown, New Jersey 206.4 miles Michelle MacKenzie 973-436-1755 None
Summit Medical Group - Morristown, New Jersey 206.4 miles Michelle MacKenzie 973-436-1755 None
Summit Medical Group - Morristown, New Jersey 206.4 miles Michelle MacKenzie 973-436-1755 None
Summit Medical Group - Morristown, New Jersey 206.4 miles Michelle MacKenzie 973-436-1755 None
Summit Medical Group - Morristown, New Jersey 206.4 miles Michelle MacKenzie 973-436-1755 None
Summit Medical Group - Morristown, New Jersey 206.4 miles Michelle MacKenzie 973-436-1755 None
St Agnes Hospital - Baltimore, Maryland 362.5 miles Elizabeth Chandler 667-234-2966 None
St Agnes Hospital - Baltimore, Maryland 362.5 miles Elizabeth Chandler 667-234-2966 None
St Agnes Hospital - Baltimore, Maryland 362.5 miles Elizabeth Chandler 667-234-2966 None
St Agnes Hospital - Baltimore, Maryland 362.5 miles Elizabeth Chandler 667-234-2966 None
St Agnes Hospital - Baltimore, Maryland 362.5 miles Elizabeth Chandler 667-234-2966 None
St Agnes Hospital - Baltimore, Maryland 362.5 miles Elizabeth Chandler 667-234-2966 None
Cleveland Clinic - Cleveland, Ohio 544.9 miles Study Coordinator 216-445-0003 None
Cleveland Clinic - Cleveland, Ohio 544.9 miles Study Coordinator 216-445-0003 None
Cleveland Clinic - Cleveland, Ohio 544.9 miles Study Coordinator 216-445-0003 None
Cleveland Clinic - Cleveland, Ohio 544.9 miles Study Coordinator 216-445-0003 None
Cleveland Clinic - Cleveland, Ohio 544.9 miles Study Coordinator 216-445-0003 None
Cleveland Clinic - Cleveland, Ohio 544.9 miles Study Coordinator 216-445-0003 None
Gabrail Cancer Center Canton Facility - Canton, Ohio 545.3 miles Kristie Armstron 330-492-3345 None
Gabrail Cancer Center Canton Facility - Canton, Ohio 545.3 miles Kristie Armstron 330-492-3345 None
Gabrail Cancer Center Canton Facility - Canton, Ohio 545.3 miles Kristie Armstron 330-492-3345 None
Gabrail Cancer Center Canton Facility - Canton, Ohio 545.3 miles Kristie Armstron 330-492-3345 None
Gabrail Cancer Center Canton Facility - Canton, Ohio 545.3 miles Kristie Armstron 330-492-3345 None
Gabrail Cancer Center Canton Facility - Canton, Ohio 545.3 miles Kristie Armstron 330-492-3345 None
Waverly Hem Onc - Cary, North Carolina 615.7 miles Gena Boyd 919-223-8585 None
Waverly Hem Onc - Cary, North Carolina 615.7 miles Gena Boyd 919-223-8585 None
Waverly Hem Onc - Cary, North Carolina 615.7 miles Gena Boyd 919-223-8585 None
Waverly Hem Onc - Cary, North Carolina 615.7 miles Gena Boyd 919-223-8585 None
Waverly Hem Onc - Cary, North Carolina 615.7 miles Gena Boyd 919-223-8585 None
Waverly Hem Onc - Cary, North Carolina 615.7 miles Gena Boyd 919-223-8585 None
Healthcare Research Network III LLC - Tinley Park, Illinois 853.0 miles Study Coordinator 314-972-9600 None
Healthcare Research Network III LLC - Tinley Park, Illinois 853.0 miles Study Coordinator 314-972-9600 None
Healthcare Research Network III LLC - Tinley Park, Illinois 853.0 miles Study Coordinator 314-972-9600 None
Healthcare Research Network III LLC - Tinley Park, Illinois 853.0 miles Study Coordinator 314-972-9600 None
Healthcare Research Network III LLC - Tinley Park, Illinois 853.0 miles Study Coordinator 314-972-9600 None
North Shore Cancer Research AssociationSkokie - Skokie, Illinois 862.1 miles Marsha Weller 847-675-3900 None
North Shore Cancer Research AssociationSkokie - Skokie, Illinois 862.1 miles Marsha Weller 847-675-3900 None
North Shore Cancer Research AssociationSkokie - Skokie, Illinois 862.1 miles Marsha Weller 847-675-3900 None
North Shore Cancer Research AssociationSkokie - Skokie, Illinois 862.1 miles Marsha Weller 847-675-3900 None
North Shore Cancer Research AssociationSkokie - Skokie, Illinois 862.1 miles Marsha Weller 847-675-3900 None
North Shore Cancer Research AssociationSkokie - Skokie, Illinois 862.1 miles Marsha Weller 847-675-3900 None
Washington University School of Medicine - Saint Louis, Missouri 1,039.5 miles Study Coordinator 314-362-0156 None
Washington University School of Medicine - Saint Louis, Missouri 1,039.5 miles Study Coordinator 314-362-0156 None
Washington University School of Medicine - Saint Louis, Missouri 1,039.5 miles Study Coordinator 314-362-0156 None
Washington University School of Medicine - Saint Louis, Missouri 1,039.5 miles Study Coordinator 314-362-0156 None
Washington University School of Medicine - Saint Louis, Missouri 1,039.5 miles Study Coordinator 314-362-0156 None
Mid Florida Hematology and Oncolcogy Center - Orange City, Florida 1,090.5 miles Ashby Rina 386-774-1223 None
Mid Florida Hematology and Oncolcogy Center - Orange City, Florida 1,090.5 miles Ashby Rina 386-774-1223 None
McFarland Clinic PC - Ames, Indiana 1,153.3 miles Study Coordinator 515-239-2621 None
McFarland Clinic PC - Ames, Indiana 1,153.3 miles Study Coordinator 515-239-2621 None
McFarland Clinic PC - Ames, Indiana 1,153.3 miles Study Coordinator 515-239-2621 None
McFarland Clinic PC - Ames, Indiana 1,153.3 miles Study Coordinator 515-239-2621 None
McFarland Clinic PC - Ames, Indiana 1,153.3 miles Study Coordinator 515-239-2621 None
McFarland Clinic PC - Ames, Indiana 1,153.3 miles Study Coordinator 515-239-2621 None
Bond Clinic PA - Winter Haven, Florida 1,161.3 miles Nikki Denmark 863-293-1191 None
Bond Clinic PA - Winter Haven, Florida 1,161.3 miles Nikki Denmark 863-293-1191 None
Bond Clinic PA - Winter Haven, Florida 1,161.3 miles Nikki Denmark 863-293-1191 None
Bond Clinic PA - Winter Haven, Florida 1,161.3 miles Nikki Denmark 863-293-1191 None
Bond Clinic PA - Winter Haven, Florida 1,161.3 miles Nikki Denmark 863-293-1191 None
Bond Clinic PA - Winter Haven, Florida 1,161.3 miles Nikki Denmark 863-293-1191 None
Boca Raton Clinical Research - Plantation, Florida 1,238.1 miles Gabriella Coletta 561-447-0614 None
Boca Raton Clinical Research - Plantation, Florida 1,238.1 miles Gabriella Coletta 561-447-0614 None
Boca Raton Clinical Research - Plantation, Florida 1,238.1 miles Gabriella Coletta 561-447-0614 None
University of Kansas Cancer Center - Westwood, Kansas 1,252.9 miles Study Coordinator 913-588-2517 None
University of Kansas Cancer Center - Westwood, Kansas 1,252.9 miles Study Coordinator 913-588-2517 None
University of Kansas Cancer Center - Westwood, Kansas 1,252.9 miles Study Coordinator 913-588-2517 None
University of Kansas Cancer Center - Westwood, Kansas 1,252.9 miles Study Coordinator 913-588-2517 None
Clinical Trials of SWLA LLC - Lake Charles, Louisiana 1,485.5 miles Jami Gardner 337-602-6642 None
Clinical Trials of SWLA LLC - Lake Charles, Louisiana 1,485.5 miles Jami Gardner 337-602-6642 None
Clinical Trials of SWLA LLC - Lake Charles, Louisiana 1,485.5 miles Jami Gardner 337-602-6642 None
Clinical Trials of SWLA LLC - Lake Charles, Louisiana 1,485.5 miles Jami Gardner 337-602-6642 None
Clinical Trials of SWLA LLC - Lake Charles, Louisiana 1,485.5 miles Jami Gardner 337-602-6642 None
Renovatio Clinical - The Woodlands, Texas 1,612.9 miles Study Coordinator 713-703-2398 None
Renovatio Clinical - The Woodlands, Texas 1,612.9 miles Study Coordinator 713-703-2398 None
Renovatio Clinical - The Woodlands, Texas 1,612.9 miles Study Coordinator 713-703-2398 None
Renovatio Clinical - The Woodlands, Texas 1,612.9 miles Study Coordinator 713-703-2398 None
Renovatio Clinical - The Woodlands, Texas 1,612.9 miles Study Coordinator 713-703-2398 None
Renovatio Clinical - The Woodlands, Texas 1,612.9 miles Study Coordinator 713-703-2398 None
University of UtahHospitalSchool of Medicine - Salt Lake City, Utah 2,094.1 miles Study Coordinator 801-587-9178 None
University of UtahHospitalSchool of Medicine - Salt Lake City, Utah 2,094.1 miles Study Coordinator 801-587-9178 None
University of UtahHospitalSchool of Medicine - Salt Lake City, Utah 2,094.1 miles Study Coordinator 801-587-9178 None
University of UtahHospitalSchool of Medicine - Salt Lake City, Utah 2,094.1 miles Study Coordinator 801-587-9178 None
University of UtahHospitalSchool of Medicine - Salt Lake City, Utah 2,094.1 miles Study Coordinator 801-587-9178 None
University of UtahHospitalSchool of Medicine - Salt Lake City, Utah 2,094.1 miles Study Coordinator 801-587-9178 None
Kaiser Permanente Northwest - Portland, Oregon 2,536.7 miles Study Coordinator 503-249-3329 None
Kaiser Permanente Northwest - Portland, Oregon 2,536.7 miles Study Coordinator 503-249-3329 None
Kaiser Permanente Northwest - Portland, Oregon 2,536.7 miles Study Coordinator 503-249-3329 None
Kaiser Permanente Northwest - Portland, Oregon 2,536.7 miles Study Coordinator 503-249-3329 None
Kaiser Permanente Northwest - Portland, Oregon 2,536.7 miles Study Coordinator 503-249-3329 None
Kaiser Permanente Northwest - Portland, Oregon 2,536.7 miles Study Coordinator 503-249-3329 None
Redlands Community Hospital - Redlands, California 2,540.6 miles Study Coordinator 909-478-7973 None
Redlands Community Hospital - Redlands, California 2,540.6 miles Study Coordinator 909-478-7973 None
Innovative Clinical Research Institute - Whittier, California 2,585.9 miles Marusa Obele 562-693-4477 None
Innovative Clinical Research Institute - Whittier, California 2,585.9 miles Marusa Obele 562-693-4477 None
Ventura County HematologyOncology Specialists - Oxnard, California 2,637.8 miles Study Coordinator 805-485-8709 None
Ventura County HematologyOncology Specialists - Oxnard, California 2,637.8 miles Study Coordinator 805-485-8709 None
Ventura County HematologyOncology Specialists - Oxnard, California 2,637.8 miles Study Coordinator 805-485-8709 None
Ventura County HematologyOncology Specialists - Oxnard, California 2,637.8 miles Study Coordinator 805-485-8709 None
Ventura County HematologyOncology Specialists - Oxnard, California 2,637.8 miles Study Coordinator 805-485-8709 None
Ventura County HematologyOncology Specialists - Oxnard, California 2,637.8 miles Study Coordinator 805-485-8709 None

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