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:
2025-12-24 @ 5:22 PM
Ignite Modification Date:
2025-12-24 @ 5:22 PM
NCT ID:
NCT00745550
Eligibility Criteria:
Inclusion Criteria
* Subjects with CIMF (including post ET/PV MF) requiring therapy, including:
* Eastern Cooperative Oncology Group (ECOG) performance status 0-2
* Men of reproductive potential who can agree to practice effective contraception during the entire study period and for one month after the last study treatment
* Women of child-bearing potential who have a negative pregnancy test within 14 days prior to the first dose of study drug and can agree to practice effective contraception during the entire study period and for one month after the last study treatment, unless documentation of infertility exists
* Subjects who are able to understand and willing to sign the informed consent form
Exclusion Criteria
* Subjects with uncontrolled inter-current illness including, but not limited to, ongoing active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements as judged by treating physician. Subjects receiving antibiotics for infections that are under control may be included in the study unless the antibiotic is a CYP3A4 inducer/inhibitor
* Subjects known to be HIV-positive
* Subjects with known active hepatitis A, B, or C, or latent hepatitis B
* Women who are pregnant or lactating
* Subjects with prior radiation therapy to more than 20% of the hematopoietic marrow (prior radiation to spleen is allowed)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00745550
Study Brief:
Protocol Section:
NCT00745550