A clinical trial with Momelotinib in subjects with Primary Myelofibrosis, Post polycythemia Vera Myelofibrosis, Post essential Thrombocythemia Myelofibrosis, Polycythemia Vera or Essential Thrombocythemia
- Conditions
- subjects with either primary myelofibrosis (PMF) or post polycythemia vera myelofibrosis or post essential thrombocythemia myelofibrosis (post-PV / ET MF) or polycythemia vera (PV) or essential thrombocythemia (ET)MedDRA version: 17.0Level: PTClassification code 10036057Term: Polycythaemia veraSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 17.0Level: PTClassification code 10028537Term: MyelofibrosisSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 17.0Level: PTClassification code 10015493Term: Essential thrombocythaemiaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2013-004476-36-DE
- Lead Sponsor
- Gilead Sciences, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 87
•Currently enrolled in study CCL09101E, or YM387-II 02, or successfully completed 24 weeks of study GS US 354 0101
•Did not end treatment with MMB for any reason other than to enroll in this study
•Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 at enrollment of this study
•Negative serum or urine pregnancy test is required for female subjects (unless surgically sterile or greater than two years post-menopausal)
•Male subjects and female subjects of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception
•Ability and agreement to attend protocol-specified visits at the study site
•Any Grade 3 or 4 non-hematologic toxicity that the investigator considers related to previous MMB use must have resolved, reverted to Grade 1, or to baseline of the prior study prior to Day 1 of this study
•Able to comprehend and willing to sign the informed consent form
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 105
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 55
•Known hypersensitivity to MMB, its metabolites, or formulation excipients
•Incomplete recovery from major surgery prior to Day 1 of this study
•Presence of peripheral neuropathy = Common Terminology Criteria for Adverse Events CTCAE Grade 3
•Known positive status for human immunodeficiency virus (HIV)
•Known chronic active or acute viral hepatitis A, B, or C infection
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method