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
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 | |
---|---|---|---|---|
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 |