DS-8201a in Human Epidermal Growth Factor Receptor2 (HER2)-Expressing Colorectal Cancer (DESTINY-CRC01)

Completed · Phase 2

Conditions studied: Colorectal Neoplasm

In brief

The main objective of this study is to test the safety and effectiveness of DS-8201a for participants with HER2-expressing advanced colorectal cancer.

Key facts

Study ID

NCT03384940

Run by

Daiichi Sankyo Co., Ltd.

People needed

86

Starts

2018-02-23

Expected to finish

2020-11-10

Last updated by the study team

2021-10-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• City of Hope Medical Center — Duarte, California, United States
• University of Southern California — Los Angeles, California, United States
• UCLA Health — Santa Monica, California, United States
• Mayo Clinic Jacksonville — Jacksonville, Florida, United States
• Karmanos Cancer Institute — Detroit, Michigan, United States
• Greenville Health System Cancer Institute — Greenville, South Carolina, United States
• West Cancer Center — Germantown, Tennessee, United States
• Vanderbilt University Medical Center — Nashville, Tennessee, United States
• MD Anderson Cancer Center, University of Texas — Houston, Texas, United States
• Università degli studi della Campania L.Vanvitelli — Naples, Campania, Italy
• Oncology Institute Veneto IOV-IRCCS — Padova, Ferrara, Italy
• ASST Grande Ospedale Metropolitano Niguarda — Milan, Lombardo, Italy
• Fondazione IRCCS - Istituto Nazionale dei Tumori — Milan, Italy
• Aichi Cancer Center Hospital — Nagoya, Aichi-ken, Japan
• National Cancer Center Hospital East — Kashiwa, Chiba, Japan
• National Hospital Organization Shikoku Cancer Center — Matsuyama, Ehime, Japan
• Hokkaido University Hospital — Sapporo, Hokkaido, Japan
• Kindai University Hospital — Ōsaka-sayama, Osaka, Japan
• The Cancer Institute Hospital of Japanese Foundation for Cancer Research — Koto-Ku, Tokyo, Japan
• National Hospital Organization Kyushu Cancer Center — Fukuoka, Japan
• Clinica Universidad de Navarra — Pamplona, Navarre, Spain
• Hospital Universitari Vall d'Hebron — Barcelona, Spain
• Hospital Universitari Clinic de Barcelona — Barcelona, Spain
• Royal Marsden Institute (Chelsea) — Chelsea, London, England, United Kingdom
• Royal Marsden Institute (Sutton) — Sutton, Surrey, England, United Kingdom

Full record on ClinicalTrials.gov

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