Ignite Creation Date:
2024-05-06 @ 4:19 PM
Last Modification Date:
2024-10-26 @ 2:08 PM
Study NCT ID:
NCT04946890
Status:
NOT_YET_RECRUITING
Last Update Posted:
2021-07-01
First Post:
2021-06-23
Brief Title:
A Study of MRX2843 in Subjects With RelapsedRefractory Acute Myeloid Leukemia
Sponsor:
Betta Pharmaceuticals Co Ltd
Organization:
Betta Pharmaceuticals Co Ltd
Study Overview
Official Title:
Phase III Clinical Study to Evaluate the Safety Tolerability Pharmacokinetics and Effectiveness of MRX2843 Tablets in Patients With RelapsedRefractory Acute Myeloid Leukemia
Status:
NOT_YET_RECRUITING
Status Verified Date:
2021-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Patients will receive oral MRX2843 for 28 days to study the side effects tolerability and best dose for treating relapsed or refractory acute myeloid leukemia With FLT3 Mutations
Detailed Description:
It is open-label dose escalation study designed to characterize the safety tolerability pharmacokinetics PK and pharmacodynamics PD of orally administered MRX2843 as a single agent given daily for 28 days
The study includes two parts Phase I and Phase II and is carried out in three phases The Phase I clinical study is divided into two phases the dose escalation study Ia and the expanded enrollment study Ib The third phase is the phase II research phase which is designed based on phase I clinical results
Phase IaCohorts of 3 patients receive MRX2843 until dose limiting toxicity is noted DLT At that point cohorts will expand to 6 patients until MTD is determined
Phase Ib IIAccording to the relevant data on safety and effectiveness expand the enrollment of FLT3 mutation relapsedrefractory AML patients at the appropriate dose
The study includes two parts Phase I and Phase II and is carried out in three phases The Phase I clinical study is divided into two phases the dose escalation study Ia and the expanded enrollment study Ib The third phase is the phase II research phase which is designed based on phase I clinical results
Phase IaCohorts of 3 patients receive MRX2843 until dose limiting toxicity is noted DLT At that point cohorts will expand to 6 patients until MTD is determined
Phase Ib IIAccording to the relevant data on safety and effectiveness expand the enrollment of FLT3 mutation relapsedrefractory AML patients at the appropriate dose
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
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