Ignite Creation Date:
2024-05-06 @ 9:46 AM
Last Modification Date:
2024-10-26 @ 12:19 PM
Study NCT ID:
NCT03072043
Status:
COMPLETED
Last Update Posted:
2022-01-24
First Post:
2017-03-02
Brief Title:
Phase 1b2 Safety and Efficacy of APR-246 wAzacitidine for tx of TP53 Mutant Myeloid Neoplasms
Sponsor:
H Lee Moffitt Cancer Center and Research Institute
Organization:
H Lee Moffitt Cancer Center and Research Institute
Study Overview
Official Title:
A Phase 1b2 Study to Evaluate the Safety and Efficacy of APR-246 in Combination With Azacitidine for the Treatment of TP53 Mutant Myeloid Neoplasms
Status:
COMPLETED
Status Verified Date:
2022-01
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:
The main purpose of this study is to determine the safe and recommended dose of APR-246 in combination with azacitidine as well as to see if this combination of therapy improves overall survival
Detailed Description:
Participants will be treated for a total of 6 cycles For participants responding or who have stable disease following cycle 6 treatment may continue until one of the following criteria applies
Inter-current illness that prevents further administration of treatment
Unacceptable adverse events
Participant decides to withdraw from the study or
General or specific changes in the participants condition render the participant unacceptable for further treatment in the judgment of the investigator
Evidence of disease progression by the International Working Group IWG 2006 criteria
Participants who wish not to continue treatment at time of disease assessment at end of cycle 6 will complete their end of treatment visit upon completion of cycle 6
Inter-current illness that prevents further administration of treatment
Unacceptable adverse events
Participant decides to withdraw from the study or
General or specific changes in the participants condition render the participant unacceptable for further treatment in the judgment of the investigator
Evidence of disease progression by the International Working Group IWG 2006 criteria
Participants who wish not to continue treatment at time of disease assessment at end of cycle 6 will complete their end of treatment visit upon completion of cycle 6
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