Ignite Creation Date:
2024-05-06 @ 7:47 PM
Last Modification Date:
2024-10-26 @ 3:13 PM
Study NCT ID:
NCT06130553
Status:
RECRUITING
Last Update Posted:
2024-07-03
First Post:
2023-10-19
Brief Title:
A Study of AZD3470 a PRMT5 Inhibitor in Patients With MTAP Deficient AdvancedMetastatic Solid Tumours
Sponsor:
AstraZeneca
Organization:
AstraZeneca
Study Overview
Official Title:
PRIMROSE A Modular Phase IIIa Multi-centre Dose Escalation and Expansion Study of AZD3470 a MTA Cooperative PRMT5 Inhibitor as Monotherapy and in Combination With Anticancer Agents in Patients With AdvancedMetastatic Solid Tumours That Are MTAP Deficient
Status:
RECRUITING
Status Verified Date:
2024-09
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:
PRIMROSE
Brief Summary:
This is a first time in human FTiH Phase IIIa open-label multi-centre study of AZD3470 in participants with advanced or metastatic solid tumours with MTAP deficiency The study consists of several study modules evaluating the safety tolerability PK pharmacodynamics and preliminary efficacy of AZD3470 as monotherapy or in combination with other anti-cancer agents
Detailed Description:
This first time in human open-label multi-centre study of AZD3470 in participants with advanced or metastatic solid tumours with MTAP deficiency follows a modular design Module 1 will include dose escalation and DDI Part A and dose optimisation and expansion Part B New modules for combination treatments may be added in the future based on emerging data
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 |
|---|---|---|---|
| 165618 | REGISTRY | IND | None |