A Phase 2, Multicenter, Open-label Study of DS-8201a in Subjects With HER2-expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma
A Phase 2, Multicenter, Open-label Study of DS-8201a in Subjects With HER2-expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma
The primary purpose of this trial is to compare the efficacy and safety of DS-8201a and physician's choice treatment in HER2-overexpressing advanced gastric or gastroesophageal junction adenocarcinoma patients who have progressed on two prior treatment regimens including fluoropyrimidine agent, platinum agent, and trastuzumab.
Inclusion Criteria:
Exclusion Criteria:
Has a medical history of myocardial infarction, symptomatic congestive heart failure (CHF) (NYHA classes II-IV), unstable angina or serious cardiac arrhythmia
Has a QTc prolongation to > 450 millisecond (ms) in males and > 470 ms in females
Has a medical history of clinically significant lung disease
Is suspected to have certain other protocol-defined diseases based on imaging at screening period
Has history of any disease, metastatic condition, drug/medication use or other condition that might, per protocol or in the opinion of the investigator, compromise:
Shiwa-gun, Iwate 028-3695, Japan
Kita, Kagawa-ken 761-0793, Japan
Bunkyō-Ku, Tokyo 113-8677, Japan
Chuo Ku, Tokyo 104-0045, Japan
Koto-Ku, Tokyo 135-8550, Japan
Koto-Ku, Tokyo 135-8577, Japan
Minato-Ku, Tokyo 105-8470, Japan
Osaka, 534-0021, Japan
Ilsan, Gyeonggi-do 10408, South Korea