A Safety and Tolerability Study of Jaktinib
A Phase 1 Dose Escalation, Safety and Tolerability Study of Jaktinib in Patients With Primary Myelofibrosis (PMF) or Post-polycythemia Vera/Post-essential Thrombocythemia Myelofibrosis (Post-PV/ET MF) and Who Are Relapsed/ Refractory to a Marketed JAK Inhibitor
1 other identifier
interventional
26
1 country
1
Brief Summary
This research study is studying a drug called Jaktinib as a possible treatment for Myelofibrosis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Jul 2024
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 2, 2022
CompletedFirst Posted
Study publicly available on registry
March 15, 2022
CompletedStudy Start
First participant enrolled
July 1, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
November 30, 2025
CompletedMarch 21, 2024
March 1, 2024
11 months
March 2, 2022
March 19, 2024
Conditions
Outcome Measures
Primary Outcomes (2)
Safety of jaktinib hydrochloride tablets
Number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment
At least 24 weeks, up to approximately 1 year for follow-up
Dose-limiting toxicities (DLTs) of jaktinib hydrochloride tablets
Number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment
28 days
Secondary Outcomes (8)
Efficacy of jaktinib hydrochloride tablets
at least 24 weeks, up to approximately 1 year
Efficacy of jaktinib hydrochloride tablets
at least 24 weeks, up to approximately 1 year
Pharmacokinetic characteristics of jaktinib hydrochloride tablets
7 days
Pharmacokinetic characteristics of jaktinib hydrochloride tablets
7 days
Pharmacokinetic characteristics of jaktinib hydrochloride tablets
7 days
- +3 more secondary outcomes
Study Arms (1)
Jaktinib
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Site 01
Canton, Ohio, 44718, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 2, 2022
First Posted
March 15, 2022
Study Start
July 1, 2024
Primary Completion
May 31, 2025
Study Completion
November 30, 2025
Last Updated
March 21, 2024
Record last verified: 2024-03
Data Sharing
- IPD Sharing
- Will not share