Study of Efficacy and Safety in Polycythemia Vera Subjects Who Are Resistant to or Intolerant of Hydroxyurea: JAK Inhibitor INC424 (INCB018424) Tablets Versus Best Available Care: (The RESPONSE Trial)
NCT ID: NCT01243944
Last Updated: 2019-03-06
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
222 participants
INTERVENTIONAL
2010-10-27
2018-02-09
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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ruxolitinib tablets
Starting dose of 10 mg BID with individualized dose titration ranging from 5 mg once a day (QD) to 25 mg BID based on safety and efficacy
ruxolitinib tablets
Starting dose of 10 mg BID with individualized dose titration ranging from 5 mg QD to 25 mg BID based on safety and efficacy
Best Available Therapy
Best Available Therapy (BAT) will be selected by the Investigator for each participant. BAT may not include experimental agents (i.e. those not approved for the treatment of any indication) as well as a limited number of other selected drugs in accordance with the protocol-defined requirements.
Best Available Therapy (BAT)
Best Available Therapy (BAT) will be selected by the Investigator for each participant. BAT may not include experimental agents (i.e. those not approved for the treatment of any indication) as well as a limited number of other selected drugs in accordance with the protocol-defined requirements.
Interventions
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ruxolitinib tablets
Starting dose of 10 mg BID with individualized dose titration ranging from 5 mg QD to 25 mg BID based on safety and efficacy
Best Available Therapy (BAT)
Best Available Therapy (BAT) will be selected by the Investigator for each participant. BAT may not include experimental agents (i.e. those not approved for the treatment of any indication) as well as a limited number of other selected drugs in accordance with the protocol-defined requirements.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Participants resistant to or intolerant of hydroxyurea
* Participants with a phlebotomy requirement
* Participants with splenomegaly (palpable or non-palpable) and a spleen volume, as measured by MRI (or CT in applicable participants ), of greater than or equal to 450 cubic centimeters
* Participants with an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2
Exclusion Criteria
* Participants with inadequate liver or renal function
* Participants with significant bacterial, fungal, parasitic, or viral infection requiring treatment
* Participants with an active malignancy within the past 5 years, excluding specific skin cancers
* Participants with known active hepatitis or HIV positivity
* Participants who have previously received treatment with a JAK inhibitor
* Participants being treated with any investigational agent
18 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Incyte Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Srdan Verstovsek, MD,PhD
Role: STUDY_DIRECTOR
M.D. Anderson Cancer Center
Mark Jones, MD
Role: STUDY_DIRECTOR
Incyte Corporation
Locations
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Birmingham, Alabama, United States
Scottsdale, Arizona, United States
Pomona, California, United States
Sacramento, California, United States
San Diego, California, United States
Bridgeport, Connecticut, United States
New Haven, Connecticut, United States
Boynton Beach, Florida, United States
Fort Myers, Florida, United States
Jacksonville, Florida, United States
Winter Park, Florida, United States
Boise, Idaho, United States
Chicago, Illinois, United States
Lafayette, Louisiana, United States
Scarborough, Maine, United States
Baltimore, Maryland, United States
Columbia, Maryland, United States
Southfield, Michigan, United States
Jefferson City, Missouri, United States
St Louis, Missouri, United States
Omaha, Nebraska, United States
Morristown, New Jersey, United States
Somerville, New Jersey, United States
Charleston, South Carolina, United States
Greenville, South Carolina, United States
Nashville, Tennessee, United States
Houston, Texas, United States
Seattle, Washington, United States
Buenos Aires, , Argentina
Brisbane, , Australia
Parkville, , Australia
Tweed Heads, , Australia
Antwerp, , Belgium
Bruges, , Belgium
Brussels, , Belgium
Leuven, , Belgium
Hamilton, , Canada
Montreal, , Canada
Toronto, , Canada
Beijing, , China
Hangzhou, , China
Avignon, , France
Bayonne, , France
Brest, , France
Lille, , France
Nantes, , France
Paris, , France
Vandœuvre-lès-Nancy, , France
Aachen, , Germany
Berlin, , Germany
Bonn, , Germany
Freiburg im Breisgau, , Germany
Hamburg, , Germany
Jena, , Germany
Magdeburg, , Germany
Mannheim, , Germany
Minden, , Germany
München, , Germany
Ulm, , Germany
Budapest, , Hungary
Kecskemét, , Hungary
Szeged, , Hungary
Szombathely, , Hungary
Bari, , Italy
Bergamo, , Italy
Bologna, , Italy
Florence, , Italy
Milan, , Italy
Napoli, , Italy
Orbassano, , Italy
Pavia, , Italy
Reggio Calabria, , Italy
Roma, , Italy
Varese, , Italy
Vicenza, , Italy
Chiba, , Japan
Chuo-city Yamanashi, , Japan
Maebashi, , Japan
Nagoya-city Aichi, , Japan
Osaka, , Japan
Tokyo, , Japan
Enschede, , Netherlands
Rotterdam, , Netherlands
Moscow, , Russia
Saint Petersburg, , Russia
Seoul, , South Korea
A Coruña, , Spain
Barcelona, , Spain
Las Palmas de Gran Canaria, , Spain
Madrid, , Spain
Majadahonda, , Spain
Málaga, , Spain
Pamplona, , Spain
Salamanca, , Spain
Valencia, , Spain
Bangkok, , Thailand
Ankara, , Turkey (Türkiye)
Istanbul, , Turkey (Türkiye)
Izmir, , Turkey (Türkiye)
Bournemouth, , United Kingdom
Cardiff, , United Kingdom
London, , United Kingdom
Countries
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References
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Kiladjian JJ, Zachee P, Hino M, Pane F, Masszi T, Harrison CN, Mesa R, Miller CB, Passamonti F, Durrant S, Griesshammer M, Kirito K, Besses C, Moiraghi B, Rumi E, Rosti V, Blau IW, Francillard N, Dong T, Wroclawska M, Vannucchi AM, Verstovsek S. Long-term efficacy and safety of ruxolitinib versus best available therapy in polycythaemia vera (RESPONSE): 5-year follow up of a phase 3 study. Lancet Haematol. 2020 Mar;7(3):e226-e237. doi: 10.1016/S2352-3026(19)30207-8. Epub 2020 Jan 23.
Kiladjian JJ, Guglielmelli P, Griesshammer M, Saydam G, Masszi T, Durrant S, Passamonti F, Jones M, Zhen H, Li J, Gadbaw B, Perez Ronco J, Khan M, Verstovsek S. Efficacy and safety of ruxolitinib after and versus interferon use in the RESPONSE studies. Ann Hematol. 2018 Apr;97(4):617-627. doi: 10.1007/s00277-017-3225-1. Epub 2018 Feb 2.
Verstovsek S, Harrison CN, Kiladjian JJ, Miller C, Naim AB, Paranagama DC, Habr D, Vannucchi AM. Markers of iron deficiency in patients with polycythemia vera receiving ruxolitinib or best available therapy. Leuk Res. 2017 May;56:52-59. doi: 10.1016/j.leukres.2017.01.032. Epub 2017 Jan 31.
Verstovsek S, Vannucchi AM, Griesshammer M, Masszi T, Durrant S, Passamonti F, Harrison CN, Pane F, Zachee P, Kirito K, Besses C, Hino M, Moiraghi B, Miller CB, Cazzola M, Rosti V, Blau I, Mesa R, Jones MM, Zhen H, Li J, Francillard N, Habr D, Kiladjian JJ. Ruxolitinib versus best available therapy in patients with polycythemia vera: 80-week follow-up from the RESPONSE trial. Haematologica. 2016 Jul;101(7):821-9. doi: 10.3324/haematol.2016.143644. Epub 2016 Apr 21.
Vannucchi AM, Kiladjian JJ, Griesshammer M, Masszi T, Durrant S, Passamonti F, Harrison CN, Pane F, Zachee P, Mesa R, He S, Jones MM, Garrett W, Li J, Pirron U, Habr D, Verstovsek S. Ruxolitinib versus standard therapy for the treatment of polycythemia vera. N Engl J Med. 2015 Jan 29;372(5):426-35. doi: 10.1056/NEJMoa1409002.
Related Links
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Related Info
Other Identifiers
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CINC424B2301
Identifier Type: -
Identifier Source: org_study_id
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