Ignite Creation Date:
2024-05-06 @ 12:26 PM
Last Modification Date:
2024-10-26 @ 12:59 PM
Study NCT ID:
NCT03760445
Status:
WITHDRAWN
Last Update Posted:
2020-01-09
First Post:
2018-11-13
Brief Title:
HDM201 Added to CT in RR or Newly Diagnosed AML
Sponsor:
Novartis Pharmaceuticals
Organization:
Novartis
Study Overview
Official Title:
A Phase III Multi-center Study of HDM201 Added to Chemotherapy in Adult Subjects With RelapsedRefractory RR or Newly Diagnosed Acute Myeloid Leukemia AML
Status:
WITHDRAWN
Status Verified Date:
2020-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
It was determined that the study design may not be optimal given the changing AML treatment landscape
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a multi-center open-label Phase III study investigating orally administered HDM201 in combination with chemotherapy in two populations subjects with first line AML or subjects with relapsedrefractory AML This study is conducted in three parts dose escalation dose expansion and DDI study
Detailed Description:
This is a Phase 1 2 study No patients were screened enrolled There are no data collected There will be no CSR
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 |
|---|---|---|---|
| 2018-003107-19 | EUDRACT_NUMBER | None | None |