Status:
COMPLETED
DS-8201a in Human Epidermal Growth Factor Receptor2 (HER2)-Expressing Colorectal Cancer (DESTINY-CRC01)
Lead Sponsor:
Daiichi Sankyo Co., Ltd.
Collaborating Sponsors:
Daiichi Sankyo
AstraZeneca
Conditions:
Colorectal Neoplasm
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The main objective of this study is to test the safety and effectiveness of DS-8201a for participants with HER2-expressing advanced colorectal cancer.
Detailed Description
At study start, only Cohort A is active. If, and when, Cohort B and C become active depends on the assessment of benefit and risk observed in the program. The sponsor will inform the investigators i...
Eligibility Criteria
Inclusion
- Has pathologically documented unresectable, recurrent, or metastatic colorectal adenocarcinoma (until sponsor's notification to the study sites, subject must be a RAS/BRAF wild-type cancer)
- Has received at least 2 prior regimens of standard treatment
- Has measurable disease assessed by the investigator based on RECIST version 1.1.
- Has an Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 to 1
Exclusion
- Has a medical history of myocardial infarction within 6 months, symptomatic congestive heart failure
- Has a medical history of clinically significant lung disease
- Has spinal cord compression or clinically active central nervous system metastases, defined as untreated and symptomatic, or requiring therapy
Key Trial Info
Start Date :
February 23 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 10 2020
Estimated Enrollment :
86 Patients enrolled
Trial Details
Trial ID
NCT03384940
Start Date
February 23 2018
End Date
November 10 2020
Last Update
October 18 2021
Active Locations (25)
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1
City of Hope Medical Center
Duarte, California, United States, 91010
2
University of Southern California
Los Angeles, California, United States, 90089
3
UCLA Health
Santa Monica, California, United States, 90404
4
Mayo Clinic Jacksonville
Jacksonville, Florida, United States, 32224-1865