AN OPEN-LABEL, MULTI-CENTER, EXPANDED ACCESS STUDY OF TRASTUZUMAB DERUXTECAN IN JAPANESE SUBJECTS WITH HER2-POSITIVE ADVANCED GASTRIC OR GASTROESOPHAGEAL JUNCTION ADENOCARCINOMA

Not Applicable

Completed

• Conditions: HER2-positive locally advanced or metastatic gastric orgastroesophageal junction adenocarcinoma

• Registration Number: JPRN-jRCT2080225138
• Lead Sponsor: DAIICHI SANKYO Co.,Ltd.

Brief Summary

This study was aimed to provide trastuzumab deruxtecan to patients with This study was aimed to provide trastuzumab deruxtecan to patients with HER2-positive advanced gastric adenocarcinoma or GEJ adenocarcinoma. The collected adverse events and their severity were generally consistent with previous results in other clinical studies in trastuzumab deruxtecan, and no new safety issues were identified.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-03-24
• Study Completion: 2020-09-25
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: completed
• Sex: All
• Target Recruitment: 64

Inclusion Criteria

1.Has a pathologically documented locally advanced or metastatic adenocarcinoma of gastric or gastroesophageal junction with HER2 positive
2.Has a medical history of at least 2 prior regimens which had to include fluoropyrimidine agent, platinum agent, and trastuzumab
3.Has an ECOG PS of 0 to 1

Exclusion Criteria

1.Has a medical history of clinically significant lung disease
2.Has active central nervous system metastases
3.Has had non-gastric or gastroesophageal junction primary malignancies within 3 years

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
safety<br>Adverse Event