A Safety and Tolerability Study of Jaktinib
Study Details
Study Description
Brief Summary
This research study is studying a drug called Jaktinib as a possible treatment for Myelofibrosis.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 1 |
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 marketed JAK inhibitor
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: Jaktinib
|
Drug: Jaktinib Hydrochloride Tablet
Orally administered, twice a day
|
Outcome Measures
Primary Outcome Measures
- Safety of jaktinib hydrochloride tablets [At least 24 weeks, up to approximately 1 year for follow-up]
Number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment
- Dose-limiting toxicities (DLTs) of jaktinib hydrochloride tablets [28 days]
Number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment
Secondary Outcome Measures
- Efficacy of jaktinib hydrochloride tablets [at least 24 weeks, up to approximately 1 year]
reduction of spleen volume of ≥35%
- Efficacy of jaktinib hydrochloride tablets [at least 24 weeks, up to approximately 1 year]
reduction of total symptoms score (TSS) of ≥50%
- Pharmacokinetic characteristics of jaktinib hydrochloride tablets [7 days]
Peak Plasma Concentration (Cmax)
- Pharmacokinetic characteristics of jaktinib hydrochloride tablets [7 days]
Time to maximum concentration (Tmax)
- Pharmacokinetic characteristics of jaktinib hydrochloride tablets [7 days]
Half-life (T1/2)
- Pharmacokinetic characteristics of jaktinib hydrochloride tablets [7 days]
Clearance (CL/F)
- Pharmacokinetic characteristics of jaktinib hydrochloride tablets [7 days]
Area under Curve (AUCinf)
- Pharmacokinetic characteristics of jaktinib hydrochloride tablets [7 days]
Volume of distribution
Eligibility Criteria
Criteria
Inclusion Criteria:
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Diagnosis of myelofibrosis (primary, post-polycythemia vera, or post-essential thrombocythemia).
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Relapsed/refractory to a marketed (FDA approved) JAK inhibitor.
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At least 18 years of age.
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ECOG PS 0, 1, or 2.
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Expected life expectancy is greater than 24 weeks.
Exclusion Criteria:
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Any chemotherapy, immunomodulatory therapy, immunosuppressive therapy, corticosteroids, or growth factor treatment within 14 days prior to initiation of study drug.
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Major surgery or radiation therapy within 28 days prior to initiation of study drug.
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With suspected allergies to jaktinib or its excipient.
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Another clinical trial of a new drug or medical instrument within 3 months before screening.
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Females who are pregnant, currently breastfeeding, planning to become pregnant.
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Unable to adopt effective contraceptive methods during the study.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Site 01 | Canton | Ohio | United States | 44718 |
Sponsors and Collaborators
- Suzhou Zelgen Biopharmaceuticals Co.,Ltd
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- ZGJAKUS001