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
- Conditions
- Neoplasms
- Registration Number
- KCT0007590
- Lead Sponsor
- Astellas Korea
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 14
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.
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.
Study & Design
- Study Type
- Observational Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method EORTC QLQ-OG25 abdominal pain/discomfort, and EORTC QLQ-C30 physical functioning, and overall global health status/quality of life scale scores
- Secondary Outcome Measures
Name Time Method Impressions of overall treatment satisfaction