Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:09 AM
Ignite Modification Date:
2025-12-25 @ 2:09 AM
NCT ID:
NCT02593760
Eligibility Criteria:
Inclusion Criteria:
* Pathologically confirmed diagnosis of primary MF, post-polycythemia vera MF, or post-essential thrombocythemia MF, according to the 2008 revised World Health Organization criteria
* Intermediate-1, intermediate-2, or high-risk according to the IWG-MRT Dynamic International Prognostic Scoring System
* Life expectancy \>= 6 months
* Peripheral blood blast count of less than (\<) 10%
* Palpable splenomegaly of greater than (\>) 5 centimeters (cm) below the left costal margin
* Eastern Cooperative Oncology Group performance status of 0 to 2
* Adequate hepatic and renal function
Exclusion Criteria:
* Prior treatment with a Hedgehog or Janus kinase pathway inhibitor
* Treatment with strong cytochrome P450 3A4 inhibitors/inducers within 28 days prior to Day 1
* Prior therapy for the treatment of intermediate- or high-risk MF including chemotherapy, interferon, thalidomide, busulfan, lenalidomide, anagrelide, or androgens within 28 days prior to Day 1
* Prior splenectomy or splenic irradiation
* Inadequate bone marrow reserve
* Participants with any history of platelet counts of \< 50,000/mccL or ANC of \< 500/mL, except during treatment for myeloproliferative neoplasm or treatment with cytotoxic therapy for any other reason
* Planned allogeneic bone marrow transplant during the study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02593760
Study Brief:
Protocol Section:
NCT02593760