Open-label Study to Assess the Long-term Safety and Efficacy of Momelotinib in Subjects with Primary Myelofibrosis, Post polycythemia Vera Myelofibrosis, Post essential Thrombocythemia Myelofibrosis, Polycythemia Vera or Essential Thrombocythemia

Gilead Sciences, Inc.0 个研究点目标入组 87 人开始时间: 2014年10月2日最近更新: 2020年6月22日

适应症

试验速览

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•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

发起方