Back to resultsA Safety and Tolerability Study of Jaktinib
Primary Purpose
Myelofibrosis
Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Jaktinib Hydrochloride Tablet
Sponsored by
About this trial
This is an interventional treatment trial for Myelofibrosis
Eligibility Criteria
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.
Sites / Locations
- Site 01Recruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Jaktinib
Arm Description
Outcomes
Primary Outcome Measures
Safety of jaktinib hydrochloride tablets
Number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment
Dose-limiting toxicities (DLTs) of jaktinib hydrochloride tablets
Number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment
Secondary Outcome Measures
Efficacy of jaktinib hydrochloride tablets
reduction of spleen volume of ≥35%
Efficacy of jaktinib hydrochloride tablets
reduction of total symptoms score (TSS) of ≥50%
Pharmacokinetic characteristics of jaktinib hydrochloride tablets
Peak Plasma Concentration (Cmax)
Pharmacokinetic characteristics of jaktinib hydrochloride tablets
Time to maximum concentration (Tmax)
Pharmacokinetic characteristics of jaktinib hydrochloride tablets
Half-life (T1/2)
Pharmacokinetic characteristics of jaktinib hydrochloride tablets
Clearance (CL/F)
Pharmacokinetic characteristics of jaktinib hydrochloride tablets
Area under Curve (AUCinf)
Pharmacokinetic characteristics of jaktinib hydrochloride tablets
Volume of distribution
Full Information
NCT ID
NCT05279001
First Posted
March 2, 2022
Last Updated
August 18, 2022
Sponsor
Suzhou Zelgen Biopharmaceuticals Co.,Ltd
1. Study Identification
Unique Protocol Identification Number
NCT05279001
Brief Title
A Safety and Tolerability Study of Jaktinib
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2022 (Actual)
Primary Completion Date
May 31, 2023 (Anticipated)
Study Completion Date
November 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Suzhou Zelgen Biopharmaceuticals Co.,Ltd
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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 marketed JAK inhibitor
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myelofibrosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
26 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Jaktinib
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Jaktinib Hydrochloride Tablet
Intervention Description
Orally administered, twice a day
Primary Outcome Measure Information:
Title
Safety of jaktinib hydrochloride tablets
Description
Number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment
Time Frame
At least 24 weeks, up to approximately 1 year for follow-up
Title
Dose-limiting toxicities (DLTs) of jaktinib hydrochloride tablets
Description
Number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment
Time Frame
28 days
Secondary Outcome Measure Information:
Title
Efficacy of jaktinib hydrochloride tablets
Description
reduction of spleen volume of ≥35%
Time Frame
at least 24 weeks, up to approximately 1 year
Title
Efficacy of jaktinib hydrochloride tablets
Description
reduction of total symptoms score (TSS) of ≥50%
Time Frame
at least 24 weeks, up to approximately 1 year
Title
Pharmacokinetic characteristics of jaktinib hydrochloride tablets
Description
Peak Plasma Concentration (Cmax)
Time Frame
7 days
Title
Pharmacokinetic characteristics of jaktinib hydrochloride tablets
Description
Time to maximum concentration (Tmax)
Time Frame
7 days
Title
Pharmacokinetic characteristics of jaktinib hydrochloride tablets
Description
Half-life (T1/2)
Time Frame
7 days
Title
Pharmacokinetic characteristics of jaktinib hydrochloride tablets
Description
Clearance (CL/F)
Time Frame
7 days
Title
Pharmacokinetic characteristics of jaktinib hydrochloride tablets
Description
Area under Curve (AUCinf)
Time Frame
7 days
Title
Pharmacokinetic characteristics of jaktinib hydrochloride tablets
Description
Volume of distribution
Time Frame
7 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jason Wu, M.D
Phone
+86-21-58942758
Email
wujs@zelgen.com
Facility Information:
Facility Name
Site 01
City
Canton
State/Province
Ohio
ZIP/Postal Code
44718
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jason Wu
Email
wujs@zelgen.com
12. IPD Sharing Statement
Plan to Share IPD
No
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A Safety and Tolerability Study of Jaktinib
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