Ignite Creation Date:
2024-05-06 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 1:53 PM
Study NCT ID:
NCT04691141
Status:
TERMINATED
Last Update Posted:
2024-04-17
First Post:
2020-12-23
Brief Title:
A Study to Evaluating the Pharmacokinetics Safety and Efficacy of ATG 016 Monotherapy in IPSS-R Intermediate Risk and Above Myelodysplastic Syndrome MDS
Sponsor:
Shanghai Antengene Corporation Limited
Organization:
Antengene Corporation
Study Overview
Official Title:
A Phase III Open-label Study to Investigate the Pharmacokinetics Safety and Efficacyof ATG 016 Monotherapy in IPSS-R Intermediate Risk and Above Myelodysplastic Syndrome MDS Patients After Failure of Hypomethylating Agent HMA-Based Therapy
Status:
TERMINATED
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The study was stopped early because the sponsor decided to change the study-drug development strategy
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HATCH
Brief Summary:
This is a Phase ⅠII Open-label Study to Investigate the Pharmacokinetics Safety and Efficacyof ATG 016 Monotherapy in IPSS-R Intermediate Risk and above Myelodysplastic Syndrome MDS Patients after Failure of Hypomethylating Agent HMA-based Therapy
Detailed Description:
This is a Phase ⅠII Open-label Study to Investigate the Pharmacokinetics Safety and Efficacyof ATG 016 Monotherapy in IPSS-R Intermediate Risk and above Myelodysplastic Syndrome MDS Patients after Failure of Hypomethylating Agent HMA-based Therapy In Phase I approximately 15 to 21 subjects and Phase II approximately 44 subjects approximately 59 to 65 subjects will be enrolled totally in this study
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