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



Status:Recruiting
Conditions:Colorectal Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:4/5/2019
Start Date:February 23, 2018
End Date:June 2020
Contact:(Japanese sites only) Daiichi Sankyo Contact for Clinical Trial Information
Email:dsclinicaltrial@daiichisankyo.co.jp
Phone:+81-3-6225-1111(M-F 9-5 JST)

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A Phase 2, Multicenter, Open-label Study of DS-8201a in Subjects With HER2-expressing Advanced Colorectal Cancer

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

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 if, and when, Cohort B and C are active.

Inclusion Criteria:

- 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 Criteria:

- 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
We found this trial at
8
sites
Houston, Texas 77030
Phone: 713-792-6161
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Los Angeles, California 90033
213) 740-2311
Phone: 614-293-6529
University of Southern California The University of Southern California is one of the world’s leading...
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Los Angeles, CA
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1211 Medical Center Dr
Nashville, Tennessee 37232
(615) 322-5000
Phone: 626-256-4673
Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
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Detroit, Michigan 48201
Phone: 323-226-2622
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Detroit, MI
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Duarte, California 91010
Phone: 626-256-4673
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Duarte, CA
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Greenville, South Carolina 29605
Phone: 800-527-6266
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Greenville, SC
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Padova, Ferrara 35128
Phone: +39 3289634053
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Padova,
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Santa Monica, California 90404
Phone: 864-699-5700
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Santa Monica, CA
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