Ignite Creation Date:
2024-05-06 @ 2:18 PM
Last Modification Date:
2024-10-26 @ 1:28 PM
Study NCT ID:
NCT04275518
Status:
RECRUITING
Last Update Posted:
2023-08-30
First Post:
2020-02-05
Brief Title:
A Phase Ib Study of APG-115 Single Agent or in Combination With Azacitidine or Cytarabine in Patients With AML and MDS
Sponsor:
Ascentage Pharma Group Inc
Organization:
Ascentage Pharma Group Inc
Study Overview
Official Title:
A Phase Ib Study to Investigate the Safety Pharmacokinetics and Pharmacodynamics of APG-115 as a Single Agent or in Combination With Azacitidine or Cytarabine in Patients With RelapseRefractory AML and RelapsedProgressed HighVery High Risk MDS
Status:
RECRUITING
Status Verified Date:
2024-10
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:
Acute myeloid leukemia is a malignant disorder characterized by the rapid uncontrolled proliferation of malignant clonal hematopoietic stem cells that accumulate as immature undifferentiated cells blasts in the bone marrow and circulation
APG-115 is a potent and orally active small-molecule MDM2 inhibitor it binds to MDM2 protein and shows potent cell growth inhibitory activity in vitro with low nanomolar potencies in a subset of human cancer cell lines APG-115 has demonstrated its strong antitumor activities with either daily or less frequent dosing-schedules in the acute leukemia xenograft models
This is a phase 1b open-label three-stages study that will initially evaluate the safety and PKPD profile of APG-115 as a single agent followed by a combination of APG-115 azacytidine or cytarabine in RR AML or MDS subjects
Patients will continue treatment for maximally 6 cycles or until progression of disease or unacceptable toxicity is observed or administrative discontinuation whichever occurs first Patients who continue to be benefit after 6 cycles treatment will receive additional cycles of treatment until progression of disease unacceptable toxicity is observed or administrative discontinuation As long as it is proven safe
APG-115 is a potent and orally active small-molecule MDM2 inhibitor it binds to MDM2 protein and shows potent cell growth inhibitory activity in vitro with low nanomolar potencies in a subset of human cancer cell lines APG-115 has demonstrated its strong antitumor activities with either daily or less frequent dosing-schedules in the acute leukemia xenograft models
This is a phase 1b open-label three-stages study that will initially evaluate the safety and PKPD profile of APG-115 as a single agent followed by a combination of APG-115 azacytidine or cytarabine in RR AML or MDS subjects
Patients will continue treatment for maximally 6 cycles or until progression of disease or unacceptable toxicity is observed or administrative discontinuation whichever occurs first Patients who continue to be benefit after 6 cycles treatment will receive additional cycles of treatment until progression of disease unacceptable toxicity is observed or administrative discontinuation As long as it is proven safe
Detailed Description:
Stage 1 This will be a 33 dose escalation to determine the DLTs and MTDRP2D of APG-115 given according to the different dose levels once daily from Days 1 to 7 every 28 days
Stage 2 After stage 1 of APG-115 single agent dose escalation first cycle is completed stage 2 can be initiated with the combination regimen This will be a 33 dose escalation to determine the MTDRP2D and DLTs of APG-115 AZAarm ACytarabine arm Bcombination
Stage 3 dose expansion of the combination regimes
Stage 2 After stage 1 of APG-115 single agent dose escalation first cycle is completed stage 2 can be initiated with the combination regimen This will be a 33 dose escalation to determine the MTDRP2D and DLTs of APG-115 AZAarm ACytarabine arm Bcombination
Stage 3 dose expansion of the combination regimes
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