Ignite Creation Date:
2024-05-06 @ 7:47 PM
Last Modification Date:
2024-10-26 @ 3:14 PM
Study NCT ID:
NCT06137144
Status:
RECRUITING
Last Update Posted:
2024-05-16
First Post:
2023-11-02
Brief Title:
AZD3470 as Monotherapy and in Combination With Anticancer Agents in Participants With RelapsedRefractory Haematologic Malignancies
Sponsor:
AstraZeneca
Organization:
AstraZeneca
Study Overview
Official Title:
A Modular Phase III Open-label Multicentre Study to Evaluate the Safety Tolerability and Efficacy of AZD3470 a PRMT5 Inhibitor as Monotherapy and in Combination With Anticancer Agents in Participants With RelapsedRefractory Haematologic Malignancies
Status:
RECRUITING
Status Verified Date:
2024-10
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:
PRIMAVERA
Brief Summary:
This study is designed to evaluate the safety tolerability PK and preliminary efficacy following oral administration of AZD3470 as a monotherapy and in combination with other anticancer agents in participants with haematologic malignancies
Detailed Description:
This is a FTiH modular Phase III open-label multicentre dose escalation and expansion study in participants with rr haematologic malignancies The study is designed to evaluate the safety tolerability PK and preliminary efficacy following oral administration of AZD3470 as a monotherapy and in combination with other anticancer agents in participants with haematologic malignancies
This study will follow a modular protocol design evaluating AZD3470 as monotherapy and in combination with other anticancer agents New cohorts including further monotherapy expansion and new modules for combination treatments may be added as protocol amendments in the future based on emerging supportive preclinical andor clinical data
Module 1 Part A includes a dose escalation of AZD3470 monotherapy in participants with rr haematologic malignancies initially focused on rr cHL Dose escalation cohorts will evaluate the safety tolerability PK and preliminary efficacy in participants with rr cHL
Module 1 Part B optimizationexpansion cohorts may be opened at selected dose levels These cohorts will further characterise the safety PK and preliminary efficacy of AZD3470 to support dose optimization Both adult and adolescent participants with rr cHL will be eligible for this part of the study Adolescent participants will only be enrolled once there is sufficient PK and safety data in adults A preliminary effect of food on AZD3470 pharmacokinetics will be explored in this part of the study
The protocol may be amended in the future to incorporate further expansion of cHL at the RP2D additional monotherapy cohorts in other hematologic malignancies andor additional modules investigating AZD3470 in combination with other anticancer agents
This study will follow a modular protocol design evaluating AZD3470 as monotherapy and in combination with other anticancer agents New cohorts including further monotherapy expansion and new modules for combination treatments may be added as protocol amendments in the future based on emerging supportive preclinical andor clinical data
Module 1 Part A includes a dose escalation of AZD3470 monotherapy in participants with rr haematologic malignancies initially focused on rr cHL Dose escalation cohorts will evaluate the safety tolerability PK and preliminary efficacy in participants with rr cHL
Module 1 Part B optimizationexpansion cohorts may be opened at selected dose levels These cohorts will further characterise the safety PK and preliminary efficacy of AZD3470 to support dose optimization Both adult and adolescent participants with rr cHL will be eligible for this part of the study Adolescent participants will only be enrolled once there is sufficient PK and safety data in adults A preliminary effect of food on AZD3470 pharmacokinetics will be explored in this part of the study
The protocol may be amended in the future to incorporate further expansion of cHL at the RP2D additional monotherapy cohorts in other hematologic malignancies andor additional modules investigating AZD3470 in combination with other anticancer agents
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