A Safety and Tolerability Study of Jaktinib
This research study is studying a drug called Jaktinib as a possible treatment for Myelofibrosis.
Conditions:
🦠 Myelofibrosis
🗓️ Study Start (Actual) 1 July 2024
🗓️ Primary Completion (Estimated) 31 May 2025
✅ Study Completion (Estimated) 30 November 2025
👥 Enrollment (Estimated) 26
🔬 Study Type INTERVENTIONAL
📊 Phase PHASE1
Locations:
📍 Canton, Ohio, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • * Diagnosis of myelofibrosis (primary, post-polycythemia vera, or post-essential thrombocythemia).
    • * Relapsed/refractory to a marketed (FDA approved) JAK inhibitor.
    • * At least 18 years of age.
    • * ECOG PS 0, 1, or 2.
    • * Expected life expectancy is greater than 24 weeks.

    Exclusion Criteria:

    • * Any chemotherapy, immunomodulatory therapy, immunosuppressive therapy, corticosteroids, or growth factor treatment within 14 days prior to initiation of study drug.
    • * Major surgery or radiation therapy within 28 days prior to initiation of study drug.
    • * With suspected allergies to jaktinib or its excipient.
    • * Another clinical trial of a new drug or medical instrument within 3 months before screening.
    • * Females who are pregnant, currently breastfeeding, planning to become pregnant.
    • * Unable to adopt effective contraceptive methods during the study.
Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 2 March 2022
  • First Submitted that Met QC Criteria 3 March 2022
  • First Posted 15 March 2022

Study Record Updates

  • Last Update Submitted that Met QC Criteria 19 March 2024
  • Last Update Posted 21 March 2024
  • Last Verified March 2024