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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) ((RESPONSE))

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Incyte Corporation
ClinicalTrials.gov Identifier:
NCT01243944
First received: November 17, 2010
Last updated: March 12, 2014
Last verified: March 2014

November 17, 2010
March 12, 2014
October 2010
February 2014   (final data collection date for primary outcome measure)
To compare the efficacy of INC424 to Best Available Therapy as assessed by both the absence of phlebotomy eligibility and reduction in spleen volume. [ Time Frame: 32 Weeks ] [ Designated as safety issue: No ]
Proportion of subjects achieving a response at Week 32. 'Response' is defined as having achieved both: (1) the absence of protocol-defined phlebotomy eligibility and (2) a ≥ 35% reduction from baseline in spleen volume as determined by imaging [ Time Frame: 32 weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01243944 on ClinicalTrials.gov Archive Site
  • To compare the proportion of subjects randomized to INC424 vs. Best Available Therapy achieving both durable absence of phlebotomy eligibility and durable spleen volume reduction. [ Time Frame: 48 Weeks. ] [ Designated as safety issue: No ]
  • To compare the proportion of subjects randomized to INC424 vs. Best Available Therapy achieving complete hematological remission. [ Time Frame: 32 Weeks ] [ Designated as safety issue: No ]
  • To determine the proportion of subjects achieving a durable spleen volume reduction [ Time Frame: 48 Weeks ] [ Designated as safety issue: No ]
  • To estimate the proportion of subjects achieving a durable complete hematological remission [ Time Frame: 48 Weeks ] [ Designated as safety issue: No ]
  • To estimate the proportion of subjects achieving a durable phlebotomy independence [ Time Frame: 48 Weeks ] [ Designated as safety issue: No ]
  • To estimate the duration of both the absence of phlebotomy eligibility and reduction in spleen volume [ Time Frame: Through study completion ] [ Designated as safety issue: No ]
  • To determine the overall clinicohematologic response rate [ Time Frame: 32 Weeks ] [ Designated as safety issue: No ]
  • To estimate the proportion of subjects achieving a durable complete or partial clinicohematologic response [ Time Frame: 48 Weeks ] [ Designated as safety issue: No ]
  • To estimate the duration of the overall clinicohematologic response [ Time Frame: Through study completion ] [ Designated as safety issue: No ]
  • To estimate the proportion of subjects achieving both durable absence of phlebotomy eligibility and durable spleen volume reduction 48 weeks after the response was initially documented [ Time Frame: Through study completion. ] [ Designated as safety issue: No ]
  • Safety and tolerability of INC424 as measured by adverse events, laboratory assessments, physical examination, vital signs, and ECG measurements. [ Time Frame: Through study completion ] [ Designated as safety issue: No ]
  • Proportion of subjects achieving complete hematologic remission at Week 32. [ Time Frame: 32 weeks ] [ Designated as safety issue: No ]
  • Proportion of all randomized subjects who both achieve the Week 32 primary response endpoint and maintain response for ≥ 48 weeks from the time that response was initially documented. [ Time Frame: At least 80 weeks ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
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)
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

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

Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Polycythemia Vera
  • Drug: INC424 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
  • Other: Best Available Therapy (BAT)
    Best Available Therapy (BAT) will be selected by the investigator for each subject. 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.
    Other Names:
    • BAT:
    • 1. Hydroxyurea
    • 2. IFN/PEG-IFN
    • 3. Pipobroman
    • 4. Anagrelide
    • 5. IMIDs
    • 6. Observation only
  • Experimental: INC424 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
    Intervention: Drug: INC424 tablets
  • Best Available Therapy
    Best Available Therapy (BAT) will be selected by the Investigator for each subject. 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.
    Intervention: Other: Best Available Therapy (BAT)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
200
September 2014
February 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Subjects diagnosed with PV for at least 24 weeks prior to screening according to the 2008 World Health Organization criteria
  • Subjects resistant to or intolerant of hydroxyurea
  • Subjects with a phlebotomy requirement
  • Subjects with a palpable splenomegaly and a spleen volume of greater than or equal to 450 cubic centimeters
  • Subjects with an ECOG performance status of 0, 1 or 2

Exclusion Criteria:

  • Women who are pregnant or nursing
  • Subjects with inadequate liver or renal function
  • Subjects with significant bacterial, fungal, parasitic, or viral infection requiring treatment
  • Subjects with an active malignancy within the past 5 years, excluding specific skin cancers
  • Subjects with known active hepatitis or HIV positivity
  • Subjects who have previously received treatment with a JAK inhibitor
  • Subjects being treated with any investigational agent
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Argentina,   Australia,   Belgium,   Canada,   China,   France,   Germany,   Hungary,   Italy,   Japan,   Korea, Republic of,   Netherlands,   Russian Federation,   Spain,   Thailand,   Turkey,   United Kingdom
 
NCT01243944
CINC424B2301
Not Provided
Incyte Corporation
Incyte Corporation
Novartis Pharmaceuticals
Study Director: Srdan Verstovsek, MD,PhD M.D. Anderson Cancer Center
Study Director: Mark Jones, MD Incyte Corporation
Incyte Corporation
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP