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
Phase 3
18 Years
N/A
18 Years
N/A
Open (Enrolling)
Both
Polycythemia Vera
Both
Polycythemia Vera
Trial Information
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
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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.
Outcome Time Frame:
32 Weeks
Safety Issue:
No
Principal Investigator
Srdan Verstovsek, MD,PhD
Investigator Role:
Study Director
Investigator Affiliation:
M.D. Anderson Cancer Center
Authority:
United States: Food and Drug Administration
Study ID:
CINC424B2301
NCT ID:
NCT01243944
Start Date:
October 2010
Completion Date:
March 2014
Related Keywords:
- Polycythemia Vera
- INCB018424
- Polycythemia
- Polycythemia Vera
Name | Location |
|---|---|
| Hinsdale, Illinois 60521 | |
| New Britain, Connecticut 06052 | |
| Bettendorf, Iowa 52722 | |
| Alexandria, Minnesota 56308 | |
| Birmingham, Alabama 35294 | |
| Phoenix, Arizona 85012 | |
| Fountain Valley, California 92708 | |
| Miami, Florida 33176 | |
| Columbia, Missouri 65203 | |
| Albany, New York 12208 | |
| Cleveland, Ohio 44195 | |
| Philadelphia, Pennsylvania 19104 | |
| Nashville, Tennessee 37203-1632 | |
| Austin, Texas 78705 | |
| Seattle, Washington 98195 | |
| Flint, Michigan 48532 | |
| McLean, Virginia 22101 | |
| Little Rock, Arkansas 72205-7199 | |
| Scarborough, Maine 04074 | |
| Omaha, Nebraska 68114 | |
| Hackensack, New Jersey 07601 | |
| Albuquerque, New Mexico 87131-5636 | |
| Metairie, Louisiana 70006 | |
| Denver, Colorado | |
| Baltimore, Maryland 21287 | |
| Boston, Massachusetts | |
| Charlotte, North Carolina | |
| Eugene, Oregon | |
| Milwaukee, Wisconsin | |
| Charleston, South Carolina | |
| Lebanon, New Hampshire | |
| Charleston, West Virginia 25304 | |
| Las Vegas, Nevada 89109 | |
| Bismarck, North Dakota 58501 | |
| Salt Lake City, Utah 84112 | |
| Coeur D'alene, Idaho 83814 |
