Ignite Creation Date:
2024-05-06 @ 3:56 PM
Last Modification Date:
2024-10-26 @ 2:00 PM
Study NCT ID:
NCT04810611
Status:
TERMINATED
Last Update Posted:
2024-05-17
First Post:
2021-03-09
Brief Title:
Phase Ib Study of Select Drug Combinations in Patients With Lower Risk MDS
Sponsor:
Novartis Pharmaceuticals
Organization:
Novartis
Study Overview
Official Title:
A Phase Ib Multicenter Open-label Platform Study of Select Drug Combinations in Adult Patients With Lower Risk Very Low Low or Intermediate Risk Myelodysplastic Syndrome
Status:
TERMINATED
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Business reasons
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study was to characterize the safety tolerability and confirm the dose for select single agents and combinations in patients with lower risk very low low and intermediate risk MDS
Detailed Description:
This was a phase Ib multi center open-label platform study with multiple treatment arms
The design of this study was adaptive to allow discontinuation of poorly tolerated or ineffective treatments and to facilitate the introduction of new candidate single agents or combinations Study design included a dose escalationconfirmation part and a dose expansion
The planned initial single agent and combination treatment arms were the following
Arm 1 MBG453 single agent
Arm 2 NIS793 single agent
Arm 3 canakinumab single agent
Arm 4 MBG453 NIS793 combination
Arm 5 MBG453 canakinumab combination Patients were treated in the dose confirmationescalation part of the study in Arms 1 2 3 and 5 No patients were treated in Arm 4 The study did not progress into the expansion phase
The design of this study was adaptive to allow discontinuation of poorly tolerated or ineffective treatments and to facilitate the introduction of new candidate single agents or combinations Study design included a dose escalationconfirmation part and a dose expansion
The planned initial single agent and combination treatment arms were the following
Arm 1 MBG453 single agent
Arm 2 NIS793 single agent
Arm 3 canakinumab single agent
Arm 4 MBG453 NIS793 combination
Arm 5 MBG453 canakinumab combination Patients were treated in the dose confirmationescalation part of the study in Arms 1 2 3 and 5 No patients were treated in Arm 4 The study did not progress into the expansion phase
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 |
|---|---|---|---|
| 2019-004623-21 | EUDRACT_NUMBER | None | None |