Status:
COMPLETED
DS-8201a in Human Epidermal Growth Factor Receptor 2 (HER2)-Expressing Gastric Cancer [DESTINY-Gastric01]
Lead Sponsor:
Daiichi Sankyo Co., Ltd.
Collaborating Sponsors:
AstraZeneca
Conditions:
Neoplasm, Gastrointestinal
Eligibility:
All Genders
20+ years
Phase:
PHASE2
Brief Summary
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...
Eligibility Criteria
Inclusion
- Has a pathologically documented locally advanced or metastatic adenocarcinoma of gastric or gastroesophageal junction
- Progression on and after at least 2 prior regimens
- Has an adequate tumor sample
- Has measurable disease based on Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1
Exclusion
- 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:
- safety or well-being of the participant or offspring
- safety of study staff
- analysis of results
Key Trial Info
Start Date :
November 2 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 11 2020
Estimated Enrollment :
233 Patients enrolled
Trial Details
Trial ID
NCT03329690
Start Date
November 2 2017
End Date
December 11 2020
Last Update
March 18 2022
Active Locations (66)
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1
Aichi Cancer Center Hospital
Nagoya, Aichi-ken, Japan, 464-8681
2
Hirosaki University Hospital
Hirosaki, Aomori, Japan, 036-8563
3
National Cancer Center Hospital East
Kashiwa, Chiba, Japan, 277-8577
4
National Hospital Organization Shikoku Cancer Center
Matsuyama, Ehime, Japan, 791-0280