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This research study is studying a drug called Jaktinib as a possible treatment for Myelofibrosis.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Jaktinib | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Jaktinib Hydrochloride Tablet | Drug | Orally administered, twice a day |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy of jaktinib hydrochloride tablets | reduction of spleen volume of ≥35% | at least 24 weeks, up to approximately 1 year |
| Efficacy of jaktinib hydrochloride tablets | reduction of total symptoms score (TSS) of ≥50% |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jason Wu, M.D | Contact | +86-21-58942758 | wujs@zelgen.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site 01 | Recruiting | Canton | Ohio | 44718 | United States |
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| ID | Term |
|---|---|
| D055728 | Primary Myelofibrosis |
| ID | Term |
|---|---|
| D009196 | Myeloproliferative Disorders |
| D001855 | Bone Marrow Diseases |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| at least 24 weeks, up to approximately 1 year |
| Pharmacokinetic characteristics of jaktinib hydrochloride tablets | Peak Plasma Concentration (Cmax) | 7 days |
| Pharmacokinetic characteristics of jaktinib hydrochloride tablets | Time to maximum concentration (Tmax) | 7 days |
| Pharmacokinetic characteristics of jaktinib hydrochloride tablets | Half-life (T1/2) | 7 days |
| Pharmacokinetic characteristics of jaktinib hydrochloride tablets | Clearance (CL/F) | 7 days |
| Pharmacokinetic characteristics of jaktinib hydrochloride tablets | Area under Curve (AUCinf) | 7 days |
| Pharmacokinetic characteristics of jaktinib hydrochloride tablets | Volume of distribution | 7 days |