Status:
COMPLETED
DS-8201a in Patients With Cancer That Tests Positive for Human Epidermal Growth Factor Receptor 2 (HER2) Protein
Lead Sponsor:
Daiichi Sankyo Taiwan Ltd., a Daiichi Sankyo Company
Collaborating Sponsors:
AstraZeneca
Conditions:
Adenocarcinoma, Gastric
Neoplasm, Breast
Eligibility:
All Genders
20+ years
Phase:
PHASE1
Brief Summary
HER2-positive cancer is a cancer that tests positive for a protein called human epidermal growth factor receptor 2 (HER2). HER2 promotes the growth of certain cancer cells. This study will test DS-820...
Detailed Description
The expected time from the first subject's enrollment until the last subject's enrollment is approximately 8 months. The screening period is 28 days and each cycle of treatment is 21 days. The number...
Eligibility Criteria
Inclusion
- Has a pathologically documented unresectable or metastatic gastric or GEJ adenocarcinoma, or breast cancer, with HER2 expression \[immunohistochemistry (IHC) 3+, 2+, or 1+ and/or in situ hybridization (ISH) +\] that is refractory to or intolerable with standard treatment, or for which no standard treatment is available
- Has a left ventricular ejection fraction (LVEF) ≥ 50%
- Has an Eastern Cooperative Oncology Group performance status (ECOG PS) score of 0 or 1
Exclusion
- Has a medical history of myocardial infarction within 6 months before enrollment
- Has a medical history of ventricular arrhythmias, other than rare occasional premature ventricular contractions
- Has uncontrolled or significant cardiovascular disease
- Has any other history or condition that might compromise:
- Safety of the participant or offspring
- Safety of study staff
- Analysis of Results
Key Trial Info
Start Date :
April 2 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 28 2022
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT03368196
Start Date
April 2 2018
End Date
September 28 2022
Last Update
November 3 2022
Active Locations (2)
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1
National Taiwan University Hospital
Taipei, Taiwan, 100
2
Taipei Veterans General Hospital
Taipei, Taiwan, 112