Ignite Creation Date:
2024-05-06 @ 10:59 AM
Last Modification Date:
2024-10-26 @ 12:38 PM
Study NCT ID:
NCT03404726
Status:
TERMINATED
Last Update Posted:
2022-01-11
First Post:
2017-11-29
Brief Title:
A Study to Investigate BAY2402234 a Dihydroorotate Dehydrogenase DHODH Inhibitor in Myeloid Malignancies
Sponsor:
Bayer
Organization:
Bayer
Study Overview
Official Title:
An Open-label Multicenter Phase 1 Study to Characterize the Safety Tolerability Preliminary Antileukemic Activity Pharmacokinetics and Maximum Tolerated Dose or Pharmacological Active Dose of BAY2402234 in Patients With Advanced Myeloid Malignancies
Status:
TERMINATED
Status Verified Date:
2021-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Lack of sufficient clinical benefit
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The primary objective is to determine the safety tolerability pharmacokinetics maximum tolerated dose MTD or pharmacological active dose PAD of BAY2402234 in patients with acute myeloid leukemia AML myelodysplastic syndrome MDS or chronic myelomonocytic leukemia CMML
The secondary objective is to evaluate evidence of clinical efficacy associated with BAY2402234 in patients with AML defined as Complete remission Complete remission with partial hematologic recovery and MDS defined as hematological improvement
The secondary objective is to evaluate evidence of clinical efficacy associated with BAY2402234 in patients with AML defined as Complete remission Complete remission with partial hematologic recovery and MDS defined as hematological improvement
Detailed Description:
None
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 |
|---|---|---|---|
| 2017-002896-24 | EUDRACT_NUMBER | None | None |