Ignite Creation Date:
2024-05-06 @ 4:58 PM
Last Modification Date:
2024-10-26 @ 2:20 PM
Study NCT ID:
NCT05155709
Status:
COMPLETED
Last Update Posted:
2024-07-05
First Post:
2021-10-20
Brief Title:
A Study of Siremadlin in Combination With Venetoclax Plus Azacitidine in Adult Participants With Acute Myeloid Leukemia AML Who Are Ineligible for Chemotherapy
Sponsor:
Novartis Pharmaceuticals
Organization:
Novartis
Study Overview
Official Title:
A Phase IbII Open Label Dose Confirmation Proof of Concept Study of Siremadlin in Combination With Venetoclax Plus Azacitidine in Unfit Adult AML Participants Who Responded Sub-optimally to First-line Venetoclax Plus Azacitidine Treatment and in Participants With Newly Diagnosed Unfit AML Presenting With High-risk Clinical Features
Status:
COMPLETED
Status Verified Date:
2024-07
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:
A study of siremadlin in combination with venetoclax plus azacitidine in adult participants with AML who are ineligible for chemotherapy
The primary purpose of this study was to assess whether siremadlin in combination with venetoclax plus azacitidine can enhance the clinical response in unfit AML patients without unacceptable levels of treatment-emergent toxicities
The primary purpose of this study was to assess whether siremadlin in combination with venetoclax plus azacitidine can enhance the clinical response in unfit AML patients without unacceptable levels of treatment-emergent toxicities
Detailed Description:
The recommended dose of siremadlin in combination with venetoclax plus azacitidine will be determined to be explored further in the expansion phase and the preliminary efficacy in achieving Complete Remission CR will be evaluated in participants who responded sub-optimally to first-line venetoclax plus azacitidine treatment
The study was planned to be conducted in two parts The primary purpose of Part 1 Safety Run- in was to rule out excessive toxicity of siremadlin when administered in combination with venetoclax plus azacitidine while the primary purpose of Part 2 Expansion was to evaluate the preliminary efficacy of siremadlin when combined with venetoclax plus azacitidine in the respective patient population
The study treatment siremadlin in combination with venetoclax plus azacitidine is administered in cycles with a planned duration of 28 days and will continue until the participants experience disease progressionrelapse or unacceptable toxicity
The initial enrollment plan and safety review was as follow
In the Safety run-in part 9-15 participants were planned to be enrolled in each arm Approximately 3-6 participants were planned to be enrolled at the starting dose level of siremadlin in combination with venetoclax plus azacitidine in both arms independently Provided the starting dose level is determined to be safe approximately 6-9 additional participants were planned to be enrolled at dose level 1 Safety review meetings were planned to take place involving participating investigators and the Sponsor Team to make decisions regarding siremadlin dose and determine the recommended dose for expansion
Approximately 26 patients were planned to be treated at the recommended dose in the expansion part
In the safety run-Part 1 27 sites were open for recruitment with 28 patients screened and 14 patients enrolled
After enrolling 14 patients 6 patients in Arm 1 and 8 patients in Arm 2 Novartis took the decision to put the enrollment in permanent halt and terminate the siremadlin program For that reason the enrollment in Part 2 expansion phase will not be open The Novartis decision was not driven by any safety concerns
The study was planned to be conducted in two parts The primary purpose of Part 1 Safety Run- in was to rule out excessive toxicity of siremadlin when administered in combination with venetoclax plus azacitidine while the primary purpose of Part 2 Expansion was to evaluate the preliminary efficacy of siremadlin when combined with venetoclax plus azacitidine in the respective patient population
The study treatment siremadlin in combination with venetoclax plus azacitidine is administered in cycles with a planned duration of 28 days and will continue until the participants experience disease progressionrelapse or unacceptable toxicity
The initial enrollment plan and safety review was as follow
In the Safety run-in part 9-15 participants were planned to be enrolled in each arm Approximately 3-6 participants were planned to be enrolled at the starting dose level of siremadlin in combination with venetoclax plus azacitidine in both arms independently Provided the starting dose level is determined to be safe approximately 6-9 additional participants were planned to be enrolled at dose level 1 Safety review meetings were planned to take place involving participating investigators and the Sponsor Team to make decisions regarding siremadlin dose and determine the recommended dose for expansion
Approximately 26 patients were planned to be treated at the recommended dose in the expansion part
In the safety run-Part 1 27 sites were open for recruitment with 28 patients screened and 14 patients enrolled
After enrolling 14 patients 6 patients in Arm 1 and 8 patients in Arm 2 Novartis took the decision to put the enrollment in permanent halt and terminate the siremadlin program For that reason the enrollment in Part 2 expansion phase will not be open The Novartis decision was not driven by any safety concerns
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 |
|---|---|---|---|
| 2021-001165-21 | EUDRACT_NUMBER | None | None |