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GS-US-352-4365

AcronymISRCTNEudraCTClinicaltrials.govDRKS
GS-US-352-43652017-004350-42NCT03441113

Extended Access of Momelotinib for Subjects with Primary Myelofibrosis (PMF) or Post-polycythemia Vera or Post-essential Thrombocythemia Myelofibrosis (Post-PV/ET MF)

Status: Active (Recruitment Closed)

Purpose / Objectives

Primary Outcome

The primary objective of this study is to provide extended access
to momelotinib (MMB) in 3 cohorts of subjects who are currently
receiving treatment with MMB and have not experienced
progression of disease:

  • Cohort 1: Study GS-US-352-0101, subjects with primary myelofibrosis (PMF) or post polycythemia vera/essential thrombocythemia myelofibrosis (post-PV/ET MF)
  • Cohort 2: Study GS-US-352-1214, subjects with PMF or post-PV/ET MF
  • Cohort 3: Study GS-US-352-1154, subjects with PMF or post-PV/ET MF

Diagnosis

Patient attributes

Inclusion criteria

  • Currently enrolled in Studies GS-US-352-0101, GS-US-352-1214, or GS-US-352-1154
  • Did not discontinue treatment with MMB for any reason while enrolled in Studies GS-US-352-0101, GS-US-352-1214, or GS-US-352-1154
  • Negative serum or urine pregnancy test is required for female subjects of childbearing potential
  • Male subjects and female subjects of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception as described
  • Any Grade 3 or 4 (Common Terminology Criteria for Adverse Events [CTCAE] Version 4.03) non-hematologic toxicity in the prior study that the investigator considers related to previousMMB use must have resolved, reverted to Grade 1, or reverted to baseline within the 30 days from the last MMB administration to Day 1 of this study
  • 6Any adverse event (AE) requiring MMB interruption during the prior study must have resolved, reverted to Grade 1, or reverted to baseline within the 30 days from last MMB administration to Day 1 of this study
  • Ability and agreement to attend protocol-specified visits at the
    study site
  • Able to comprehend and willing to sign the informed consent
    form

Exclusion criteria

  • Known hypersensitivity to MMB, its metabolites, or formulation
    excipients
  • Incomplete recovery from major surgery prior to Day 1 of this study
  • Pregnant or lactating females
  • Presence of ≥ Grade 3 (CTCAE Version 4.03) peripheral neuropathy
  • Known positive status for human immunodeficiency virus (HIV)
  • [...]

Trial design

  • Phase III
  • Multicenter
  • Prospective

Intervention

  • MMB 100 mg, 150 mg, or 200 mg tablet orally self-administered once-daily.

Documents (password protected)

Responsibilities in overall trial

Gilead Sciences, Inc.

    Study Sites

    Klinik I für Innere Medizin

    Study office

    • Klinisches Studienzentrum der Klinik I für Innere Medizin Köln

    Status

    Active (Recruitment Closed)

    Principal Investigator

    Prof. Dr. med. Dr. h. c. Christoph Scheid

    Contact at Site