Ignite Creation Date:
2024-05-06 @ 8:20 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06346392
Status:
RECRUITING
Last Update Posted:
2024-06-26
First Post:
2024-02-28
Brief Title:
AZD0901 Compared With Investigators Choice of Therapy in Participants With Second- or Later-line Advanced or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma Expressing Claudin182
Sponsor:
AstraZeneca
Organization:
AstraZeneca
Study Overview
Official Title:
A Phase III Multi-center Open-label Sponsor-blinded Randomized Study of AZD0901 Monotherapy Compared With Investigators Choice of Therapy in Second- or Later-Line Adult Participants With AdvancedMetastatic Gastric or Gastroesophageal Junction Adenocarcinoma Expressing Claudin182
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:
None
Brief Summary:
The purpose of this study is to measure the efficacy and safety of AZD0901 compared to Investigators choice of therapy as 2L treatment for participants with advanced or metastatic gastric or GEJ adenocarcinoma expressing CLDN182
Detailed Description:
This is a Phase III multi-center open-label sponsor-blinded randomized global study to assess the efficacy and safety of AZD0901 compared to Investigators choice of therapy as the 2L treatment for participants with advanced or metastatic gastric or GEJ adenocarcinoma expressing CLDN182 and the clinical performance of the investigational IVD As part of this combined approach the efficacy analyses from this study will also provide the basis to evaluate the clinical performance of Ventana CLDN182 assay as an IVD device for the identification of patients with advanced or metastatic gastric or GEJ adenocarcinoma expressing CLDN182 who may benefit from AZD0901
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