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)



Status:Completed
Conditions:Cancer, Hematology
Therapuetic Areas:Hematology, Oncology
Healthy:No
Age Range:18 - Any
Updated:3/8/2019
Start Date:October 27, 2010
End Date:February 9, 2018

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Randomized, Open Label, Multicenter Phase III Study of Efficacy and Safety in Polycythemia Vera Subjects Who Are Resistant to or Intolerant of Hydroxyurea: JAK Inhibitor INC424 Tablets Versus Best Available Care (The RESPONSE Trial)

This pivotal phase III trial (CINC424B2301) is designed to compare the efficacy and safety of
ruxolitinib (INC424) to Best Available Therapy (BAT) in participants with polycythemia vera
(PV) who are resistant to or intolerant of hydroxyurea (HU).


Inclusion Criteria:

- Participants diagnosed with PV for at least 24 weeks prior to screening according to
the 2008 World Health Organization 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:

- Women who are pregnant or nursing

- 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
We found this trial at
29
sites
1357
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Houston, TX
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2301
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Baltimore, MD
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1784
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Birmingham, AL
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665
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Boise, ID
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2309
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Boynton Beach, FL
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2473
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Bridgeport, CT
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6113
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Buenos Aires,
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Charleston, South Carolina 29412
2184
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Charleston, SC
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1729
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from 91732
Chicago, IL
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2288
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from 91732
Columbia, MD
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2204
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Fort Myers, FL
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Greenville, South Carolina 29605
2019
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Greenville, SC
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2127
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Jacksonville, FL
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1462
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Jefferson City, MO
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1538
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Lafayette, LA
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2407
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Morristown, NJ
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1763
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Nashville, TN
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2486
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New Haven, CT
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1300
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Omaha, NE
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15
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Pomona, CA
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364
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Sacramento, CA
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1573
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Saint Louis, MO
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105
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San Diego, CA
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2611
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Scarborough, ME
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352
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Scottsdale, AZ
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964
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Seattle, WA
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2401
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from 91732
Somerville, NJ
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1958
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from 91732
Southfield, MI
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2184
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from 91732
Winter Park, FL
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