Status:
COMPLETED
Study of DS-8201a for Participants With Advanced Solid Malignant Tumors
Lead Sponsor:
Daiichi Sankyo Co., Ltd.
Collaborating Sponsors:
AstraZeneca
Conditions:
Neoplasm Metastasis
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 an exp...
Detailed Description
The expected time from the first subject's enrollment until the last subject's enrollment is approximately 8.5 months. The screening period is 28 days and each cycle of treatment is 21 days. The data...
Eligibility Criteria
Inclusion
- Has a pathologically documented unresectable or metastatic solid malignant tumor, with HER2 expression \[immunohistochemistry (IHC) 3+, 2+, or 1+ and/or in situ hybridization (ISH) +\], Next Generation Sequencing, or other analysis techniques as appropriate\] that is refractory to or intolerable with at least one prior systemic chemotherapy regimen, 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 contraindication for receiving ritonavir or itraconazole according to the prescribing information
- Has a medical history of myocardial infarction within 6 months before enrollment or symptomatic congestive heart failure
Key Trial Info
Start Date :
January 12 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 11 2023
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT03383692
Start Date
January 12 2018
End Date
September 11 2023
Last Update
December 11 2023
Active Locations (10)
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1
Hokkaido Cancer Center
Sapporo, Hokkaido, Japan, 003-0804
2
Hokkaido University Hospital
Sapporo, Hokkaido, Japan, 060-8648
3
Kobe University Hospital
Kobe, Hyōgo, Japan, 650-0017
4
Hamamatsu University Hospital
Hamamatsu, Shizuoka, Japan, 431-3125