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WITHDRAWNPHASE1

A Study of LNK01002 in Patients With Primary or Secondary Myelofibrosis,Polycythemia Vera or Acute Myeloid Leukemia

An Open-Label, Multicenter, Phase I Study to Evaluate the Safety, Pharmacokinetics and Preliminary Efficacy of LNK01002 in Patients With Malignant Myeloid Hematologic Neoplasms

NCT04896112•Lynk Pharmaceuticals Co., Ltd

View on ClinicalTrials.gov

Summary

This multicenter, open-label, phase 1 study designed to evaluate safety and tolerability of multi-kinase inhibitor LNK01002 in patients with primary myelofibrosis (PMF), or MF due to polycythemia vera (PV-MF), or essential thrombocythemia (ET-MF), polycythemia vera (PV), or with acute myeloid leukemia (AML).

Detailed Description

This is a Phase I, open-label, dose-finding study of the triple kinase inhibitor LNK01002 in patients with Malignant Myeloid Hematologic Neoplasms. 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 Malignant Myeloid Hematologic Neoplasms 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 ,PV or PV/ET-MF. The safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary clinical activity of LNK01002 in patients with Malignant Myeloid Hematologic Neoplasms will be evaluated.

Eligibility

Age

18 - 99 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Age: 18 years old or older, male or female.
•2. Patients must have histologically or cytologically confirmed tumors of the following types.
•* Dose Escalation Phase: Patients with PMF,PV/ET-MF,PV
•1. Intermediate or high-risk primary myelofibrosis, intermediate or high-risk post-polycythemia vera myelofibrosis , or post-essential thrombocythemia myelofibrosis , or high-risk polycythemia vera who have no available therapy or relapsed after allogeneic hematopoietic cell transplantation.
•2. Symptomatic splenomegaly
•3. Not undergone splenectomy or splenic radiation therapy within 6 months prior to screening.
•* Dose expansion phase: Patients with PMF, PV/ET-MF,PV who relapsed or are intolerant to standard treatment, and relapsed/refractory AML
•3. Platelet count ≥ 100 × 10e9/L within 14 days before study drug administration
•4. Absolute neutrophil count (ANC) ≥ 1.5 × 10e9/L within 14 days before study drug administration
•5. Women of childbearing potential negative pregnancy test at screening. Female patients of childbearing potential, or male patients and their partners should agree to effective contraception from signing ICF until 6 months after the last dose of study drug.

Exclusion Criteria

•1. Allergic to any component of LNK01002.
•2. Serum total bilirubin greater than 1.5 times the upper limit of the normal (ULN) reference range, except patients diagnosed as Gilbert's disease
•3. ALT or AST higher than 3 times the ULN reference range without hepatic involvement by leukemia, which are excluded if higher than 5 times the ULN
•4. Glomerular filtration rate or estimated creatinine clearance \< 50 mL/min according to the Cockcroft-Gault formula;
•5. Serum amylase or lipase levels higher than the ULN and considered clinically significant
•6. International normalized ratio (INR) or partial activated prothrombin time (aPTT) above 1.5 times the ULN reference range
•7. Known history of clinically significant liver disease, including viral or other hepatitis:
•a) Patients with hepatitis B or hepatitis C may be enrolled if they have a negative polymerase chain reaction (PCR)
•8. Known human immunodeficiency virus (HIV) infection;
•9. Clinically significant cardiovascular diseases, including acute myocardial infarction, unstable angina, coronary artery bypass surgery within 6 months before enrollment, congestive heart failure with New York Heart Association (NYHA) classification of III or above, left ventricular ejection fraction (LVEF) \< 50%, or uncontrolled hypertension, cardiac arrhythmia;
+6 more criteria

Locations (2)

Revive Research Institute

Farmington Hills, Michigan, United States

Revive Research Institute

Sterling Heights, Michigan, United States

Key Dates

Start Date

April 8, 2021

Primary Completion Date

October 20, 2022

Completion Date

October 20, 2022

Last Updated

June 18, 2023

Conditions

Acute Myeloid LeukemiaPrimary MyelofibrosisPost-polycythemia Vera MyelofibrosisPost-essential Thrombocythemia MyelofibrosisPolycythemia Vera

Interventions

LNK01002

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 18, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

A Study of LNK01002 in Patients With Primary or Secondary Myelofibrosis,Polycythemia Vera or Acute Myeloid Leukemia

Inclusion Criteria

Exclusion Criteria

Phase I Study of HC-7366 for Acute Myeloid Leukemia

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