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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT2080225138
Enrollment
100
Registered
2020-03-24
Start date
2020-04-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HER2-positive locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma

Interventions

Sponsors

DAIICHI SANKYO Co.,Ltd.
Lead Sponsor
AstraZeneca
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
safety Adverse Event

Countries

Japan

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026