Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Acute Myeloid Leukemia
  • Post Essential Thrombocythemia Myelofibrosis
  • Post Polycythemia Vera Myelofibrosis
  • Primary Myelofibrosis
Type
Interventional
Phase
Phase 1
Design
Allocation: Non-RandomizedIntervention Model: Sequential AssignmentIntervention Model Description: An Open-Label, Multicenter, Phase I Study to Evaluate the Safety, Pharmacokinetics and Preliminary Efficacy of LNK01002Masking: None (Open Label)Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 99 years
Gender
Both males and females

Description

This is a Phase I, open-label, dose-finding study of the triple kinase inhibitor LNK01002 in patients with myelofibrosis (MF). The study consists of two periods: the dose escalation, main period and a dose expansion period. In the dose escalation period, successive cohorts of patients with MF will b...

This is a Phase I, open-label, dose-finding study of the triple kinase inhibitor LNK01002 in patients with myelofibrosis (MF). The study consists of two periods: the dose escalation, main period and a dose expansion period. In the dose escalation period, successive cohorts of patients with MF will be enrolled to establish the maximum tolerated dose. In the dose expansion period (dose-confirmation phase), three cohorts of patients will be enrolled: AML patients with confirmed FLT3-ITD mutations, AML patients without FLT3-ITD mutations, and patients with primary MF or PV/ET-MF. The safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary clinical activity of LNK01002 in patients with myelofibrosis/AML will be evaluated.

Tracking Information

NCT #
NCT04896112
Collaborators
Not Provided
Investigators
Study Director: Sherry Weigand, M.D., Ph.D. Lynk Pharmaceuticals Co., Ltd
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