FindTrial
Sign In

A Noninterventional Exit Survey Study to Understand Meaningful Change in Subjects with Claudin (CLDN) 18.2-Positive, HER2-Negative, Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma who Discontinued Treatment in the SPOTLIGHT or GLOW Study

A Noninterventional Exit Survey Study to Understand Meaningful Change in Subjects with Claudin (CLDN) 18.2-Positive, HER2-Negative, Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma who Discontinued Treatment in the SPOTLIGHT or GLOW Study

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
CRIS
Registry ID
KCT0007590
Enrollment
14
Registered
2022-07-29
Start date
2022-06-02
Completion date
Unknown
Last updated
2022-09-20

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

Conditions

None listed

Interventions

None listed

Sponsors

Astellas Korea
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved written informed consent and privacy language as per national regulations (e.g., HIPAA Authorization for US sites) must be obtained from the subject or legally authorized representative (if applicable) prior to any study-related procedures. 2. Subjects who are within 30 days following the treatment discontinuation visit(s) (both study treatments) in the SPOTLIGHT (8951-CL-0301) or GLOW (8951-CL-0302) study.

Exclusion criteria

Exclusion criteria: 1. Subject has any concurrent disease, infection or comorbid condition that interferes with the ability of the subject to participate in the study, which places the subject at undue risk or complicates the interpretation of data in the opinion of the investigator.

Design outcomes

Primary

MeasureTime frame
EORTC QLQ-OG25 abdominal pain/discomfort, and EORTC QLQ-C30 physical functioning, and overall global health status/quality of life scale scores—

Secondary

MeasureTime frame
Impressions of overall treatment satisfaction—

Countries

Korea, Republic of

Contacts

Public ContactSang Cheul Oh

Koera University Guro Hospital

sachoh@korea.ac.kr+82-2-2626-3060

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 4, 2026