Status:
RECRUITING
A Safety and Tolerability Study of Jaktinib
Lead Sponsor:
Suzhou Zelgen Biopharmaceuticals Co.,Ltd
Conditions:
Myelofibrosis
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This research study is studying a drug called Jaktinib as a possible treatment for Myelofibrosis.
Detailed Description
This study is a Phase 1, single-arm, open-label, dose escalation trial, to evaluate the safety and tolerability of Jaktinib in patients with PMF or Post-PV/ET MF and who are relapsed/refractory to a m...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 30 2025
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT05279001
Start Date
July 1 2024
End Date
November 30 2025
Last Update
March 21 2024
Active Locations (1)
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1
Site 01
Canton, Ohio, United States, 44718