Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00003808

Trial Description

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Title

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

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Trial Acronym

(RESPONSE)

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URL of the Trial

[---]*

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Brief Summary in Lay Language

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).

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Brief Summary in Scientific Language

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Organizational Data

  •   DRKS00003808
  •   2012/05/02
  •   2010/11/17
  •   no
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Secondary IDs

  •   NCT01243944  (ClinicalTrials.gov)
  •   CINC424B2301  (Incyte Corporation)
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Health Condition or Problem studied

  •   Polycythemia Vera
  •   D45 -  Polycythaemia vera
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Interventions/Observational Groups

  •   Drug: INC424 tablets
  •   Other: Best Available Therapy (BAT)
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Other
  •   Treatment
  •   Parallel
  •   III
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Primary Outcome

- 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

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Secondary Outcome

- 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.
- To compare the proportion of subjects randomized to INC424 vs. Best Available Therapy achieving complete hematological remission.; time frame: 32 Weeks
- To determine the proportion of subjects achieving a durable spleen volume reduction; time frame: 48 Weeks
- To estimate the proportion of subjects achieving a durable complete hematological remission; time frame: 48 Weeks
- To estimate the proportion of subjects achieving a durable phlebotomy independence; time frame: 48 Weeks
- To estimate the duration of both the absence of phlebotomy eligibility and reduction in spleen volume; time frame: Through study completion
- To determine the overall clinicohematologic response rate; time frame: 32 Weeks
- To estimate the proportion of subjects achieving a durable complete or partial clinicohematologic response; time frame: 48 Weeks
- To estimate the duration of the overall clinicohematologic response; time frame: Through study completion
- 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.
- Safety and tolerability of INC424 as measured by adverse events, laboratory assessments, physical examination, vital signs, and ECG measurements.; time frame: Through study completion

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Countries of Recruitment

  •   United States
  •   Argentina
  •   Australia
  •   Belgium
  •   Canada
  •   China
  •   France
  •   Germany
  •   Hungary
  •   Italy
  •   Japan
  •   Korea, Republic of
  •   Netherlands
  •   Russian Federation
  •   Spain
  •   Thailand
  •   Turkey
  •   United Kingdom
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Locations of Recruitment

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Recruitment

  •   Actual
  •   2010/10/31
  •   200
  •   Multicenter trial
  •   International
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional 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

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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

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Addresses

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    • Incyte Corporation
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    • M.D. Anderson Cancer Center
    • Srdan Verstovsek, MD,PhD 
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    • M.D. Anderson Cancer Center
    • Srdan Verstovsek, MD,PhD 
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Sources of Monetary or Material Support

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Status

  •   Recruiting complete, follow-up continuing
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Trial Publications, Results and other Documents

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The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   8
  •   2013/10/20
* This entry means the parameter is not applicable or has not been set.