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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03384940
Recruitment Status : Recruiting
First Posted : December 28, 2017
Last Update Posted : July 26, 2019
Sponsor:
Collaborators:
Daiichi Sankyo, Inc.
AstraZeneca
Information provided by (Responsible Party):
Daiichi Sankyo, Inc. ( Daiichi Sankyo Co., Ltd. )

Study Description
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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.

Condition or disease Intervention/treatment Phase
Colorectal Neoplasm Drug: DS-8201a Phase 2

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


Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2, Multicenter, Open-label Study of DS-8201a in Subjects With HER2-expressing Advanced Colorectal Cancer
Actual Study Start Date : February 23, 2018
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: DS-8201a Cohort A

Cohort A is comprised of participants with HER2-positive (IHC 3+ or IHC 2+/ISH +) who will receive DS-8201a once every 3 weeks

Enrollment to this cohort was closed and this cohort is active until study completion.

 Drug: DS-8201a
DS-8201a is comprised of an antibody component conjoined to a drug component in a lyophilized powder, which is made into solution for intravenous administration
Other Name: Experimental product
Experimental: DS-8201a Cohort B

Cohort B is comprised of participants with HER2 IHC 2+/ISH - who will receive DS-8201a once every 3 weeks

This cohort is active.

 Drug: DS-8201a
DS-8201a is comprised of an antibody component conjoined to a drug component in a lyophilized powder, which is made into solution for intravenous administration
Other Name: Experimental product
Experimental: DS-8201a Cohort C

Cohort C is comprised of participants with HER2 IHC 1+ who will receive DS-8201a once every 3 weeks

This cohort is active.

 Drug: DS-8201a
DS-8201a is comprised of an antibody component conjoined to a drug component in a lyophilized powder, which is made into solution for intravenous administration
Other Name: Experimental product


Outcome Measures
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Primary Outcome Measures :
  1. Objective response rate (ORR) per imaging assessment [ Time Frame: from Cycle 1 Day 1 through disease progression (within 18 months) ]
    Percentage of participants with objective response per independent central imaging facility review based on Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1 in Cohort A


Secondary Outcome Measures :
  1. Progression-free survival [ Time Frame: within 18 months ]
    Percentage of participants still alive without the disease getting worse

  2. Overall survival (OS) [ Time Frame: at 18 months ]
    Percentage of participants still alive

  3. Duration of response [ Time Frame: within 18 months ]
    Length of time response continued

  4. Disease control rate (DCR) [ Time Frame: within 18 months ]
    Percentage of participants with controlled disease

  5. ORR assessed by the investigator based on RECIST version 1.1 [ Time Frame: within 18 months ]
    Percentage of participants with objective response as assessed by the investigator, based on RECIST version 1.1

  6. Maximum serum/plasma concentration (Cmax) [ Time Frame: within 21 days ]
    Categories: DS-8201a, total anti-HER2 antibody, and MAAA-1181a

  7. Time to Cmax (Tmax) [ Time Frame: within 21 days ]
    Categories: DS-8201a, total anti-HER2 antibody, and MAAA-1181a

  8. Area under the concentration-time curve (AUC) from dosing until the last quantifiable concentration (AUClast) [ Time Frame: within 21 days ]
    Categories: DS-8201a, total anti-HER2 antibody, and MAAA-1181a

  9. AUC from the time of dosing until day 21 (AUC0-21d) [ Time Frame: at Day 21 ]
    Categories: DS-8201a, total anti-HER2 antibody, and MAAA-1181a


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03384940


Contacts
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Contact: (Japanese sites only) Daiichi Sankyo Contact for Clinical Trial Information +81-3-6225-1111(M-F 9-5 JST) dsclinicaltrial@daiichisankyo.co.jp

Locations
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United States, California
City of Hope Medical Center Recruiting
Duarte, California, United States, 91010
Contact: Principal Investigator    626-256-4673    mfakih@coh.org   
University of Southern California Recruiting
Los Angeles, California, United States, 90089
Contact: Principal Investigator    323-865-3967    LENZ@med.usc.edu   
UCLA Health Recruiting
Santa Monica, California, United States, 90404
Contact: Principal Investigator    800-825-2631    zwainberg@mednet.ucla.edu   
United States, Florida
Mayo Clinic Jacksonville Recruiting
Jacksonville, Florida, United States, 32224-1865
Contact: Principal Investigator    904-953-0853    starr.jason@mayo.edu   
United States, Michigan
Karmanos Cancer Institute Recruiting
Detroit, Michigan, United States, 48201
Contact: Principal Investigator    313-576-8735    shieldsa@karmanos.org   
United States, South Carolina
Greenville Health System Cancer Institute Recruiting
Greenville, South Carolina, United States, 29605-4255
Contact: Principal Investigator    864-699-5700    kchung@ghs.org   
United States, Tennessee
West Cancer Center Recruiting
Germantown, Tennessee, United States, 38138
Contact: Principal Investigator    901-683-0055    agrothey@WESTCLINIC.com   
Vanderbilt University Medical Center Recruiting
Nashville, Tennessee, United States, 37232
Contact: Principal Investigator    615-322-5000    kristen.k.ciombor@vanderbilt.edu   
United States, Texas
MD Anderson Cancer Center, University of Texas Recruiting
Houston, Texas, United States, 77030-4000
Contact: Principal Investigator    713-792-6161    KPRaghav@mdanderson.org   
Italy
Università degli studi della Campania L.Vanvitelli Recruiting
Napoli, Campania, Italy, 80131
Contact: Principal Investigator    +39 0815666745    fortunato.ciardiello@unicampania.it   
Oncology Institute Veneto IOV-IRCCS Recruiting
Padova, Ferrara, Italy, 35128
Contact: Principal Investigator    +39-840-000-664    fotios.loupakis@iov.veneto.it   
ASST Grande Ospedale Metropolitano Niguarda Recruiting
Milano, Lombardo, Italy, 20162
Contact: Principal Investigator    +39-02-6444-1    salvatore.siena@unimi.it   
Fondazione IRCCS - Istituto Nazionale dei Tumori Recruiting
Milan, Italy, 20133
Contact: Principal Investigator    +39-02-2390-1    maria.dibartolomeo@istitutotumori.mi.it   
Japan
Aichi Cancer Center Hospital Recruiting
Nagoya, Aichi, Japan, 464-8681
Contact: See Central Contact         
National Cancer Center Hospital East Recruiting
Kashiwa, Chiba, Japan, 277-8577
Contact: See Central Contact         
National Hospital Organization Shikoku Cancer Center Recruiting
Matsuyama, Ehime, Japan, 791-0280
Contact: See Central Contact         
Hokkaido University Hospital Recruiting
Sapporo, Hokkaido, Japan, 060-8648
Contact: See Central Contact         
Kindai University Hospital Recruiting
Ōsaka-sayama, Osaka, Japan, 589-8511
Contact: See Central Contact         
The Cancer Institute Hospital of Japanese Foundation for Cancer Research Recruiting
Koto-Ku, Tokyo, Japan, 135-8550
Contact: See Central Contact         
National Hospital Organization Kyushu Cancer Center Recruiting
Fukuoka, Japan, 811-1395
Contact: See Central Contact         
Spain
Clinica Universidad de Navarra Recruiting
Pamplona, Navarre, Spain, 31008
Contact: Principal Investigator    +34 948255400    jrodriguez@unav.es   
Hospital Universitari Vall d'Hebron Recruiting
Barcelona, Spain, 08035
Contact: Principal Investigator    +34 93 489 30 00    meelez@vhio.net   
Hospital Universitari Clinic de Barcelona Recruiting
Barcelona, Spain, 08036
Contact: Principal Investigator    +34- 932-275400    JMAUREL@clinic.cat   
United Kingdom
Royal Marsden Institute (Chelsea) Recruiting
Chelsea, London, England, United Kingdom, SM2 5PT
Contact: Principal Investigator    +44-020-7352-8171    Ian.Chau@rmh.nhs.uk   
Royal Marsden Institute (Sutton) Recruiting
Sutton, Surrey, England, United Kingdom, SW3 6JJ
Contact: Principal Investigator    +44-020-8642-6011    Ian.Chau@rmh.nhs.uk   
Sponsors and Collaborators
Daiichi Sankyo Co., Ltd.
Daiichi Sankyo, Inc.
AstraZeneca
Investigators
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Study Director: Global Clinical Leader Daiichi Sankyo, Inc.
More Information
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Responsible Party: Daiichi Sankyo Co., Ltd.
ClinicalTrials.gov Identifier: NCT03384940     History of Changes
Other Study ID Numbers: DS8201-A-J203
2017-003466-28 ( EudraCT Number )
173808 ( Registry Identifier: JAPIC CTI )
First Posted: December 28, 2017    Key Record Dates
Last Update Posted: July 26, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame: Studies for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.
Access Criteria: Formal request from qualified scientific and medical researchers on IPD and clinical study documents from clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent.
URL: https://vivli.org/ourmember/daiichi-sankyo/

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Daiichi Sankyo, Inc. ( Daiichi Sankyo Co., Ltd. ):
Oncology
HER2
Colorectal cancer
Antibody drug conjugate
ADC
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
 Camptothecin
Immunoconjugates
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Physiological Effects of Drugs