Ignite Creation Date:
2024-05-06 @ 4:09 PM
Last Modification Date:
2024-10-26 @ 2:05 PM
Study NCT ID:
NCT04896112
Status:
WITHDRAWN
Last Update Posted:
2023-06-18
First Post:
2021-05-08
Brief Title:
A Study of LNK01002 in Patients With Primary or Secondary MyelofibrosisPolycythemia Vera or Acute Myeloid Leukemia
Sponsor:
Lynk Pharmaceuticals Co Ltd
Organization:
Lynk Pharmaceuticals Co Ltd
Study Overview
Official Title:
An Open-Label Multicenter Phase I Study to Evaluate the Safety Pharmacokinetics and Preliminary Efficacy of LNK01002 in Patients With Malignant Myeloid Hematologic Neoplasms
Status:
WITHDRAWN
Status Verified Date:
2023-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
sponsor decision
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 PVET-MF
The safety tolerability pharmacokinetics pharmacodynamics and preliminary clinical activity of LNK01002 in patients with Malignant Myeloid Hematologic Neoplasms will be evaluated
The safety tolerability pharmacokinetics pharmacodynamics and preliminary clinical activity of LNK01002 in patients with Malignant Myeloid Hematologic Neoplasms will be evaluated
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| IND 153144 | REGISTRY | FDA | None |