DS-8201a in Human Epidermal Growth Factor Receptor2 (HER2)-Expressing Colorectal Cancer (DESTINY-CRC01)
NCT ID: NCT03384940
Last Updated: 2021-10-18
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
86 participants
INTERVENTIONAL
2018-02-23
2020-11-10
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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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
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
DS-8201a Cohort B
Cohort B is comprised of participants with HER2 IHC 2+/ISH - who will receive DS-8201a once every 3 weeks
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
DS-8201a Cohort C
Cohort C is comprised of participants with HER2 IHC 1+ who will receive DS-8201a once every 3 weeks
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
Interventions
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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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 clinically significant lung disease
* Has spinal cord compression or clinically active central nervous system metastases, defined as untreated and symptomatic, or requiring therapy
18 Years
ALL
No
Sponsors
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Daiichi Sankyo
INDUSTRY
AstraZeneca
INDUSTRY
Daiichi Sankyo Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Global Clinical Leader
Role: STUDY_DIRECTOR
Daiichi Sankyo
Locations
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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
Napoli, Campania, Italy
Oncology Institute Veneto IOV-IRCCS
Padua, 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
Countries
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References
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Siena S, Raghav K, Masuishi T, Yamaguchi K, Nishina T, Elez E, Rodriguez J, Chau I, Di Bartolomeo M, Kawakami H, Suto F, Koga M, Inaki K, Kuwahara Y, Takehara I, Barrios D, Kobayashi K, Grothey A, Yoshino T. HER2-related biomarkers predict clinical outcomes with trastuzumab deruxtecan treatment in patients with HER2-expressing metastatic colorectal cancer: biomarker analyses of DESTINY-CRC01. Nat Commun. 2024 Nov 25;15(1):10213. doi: 10.1038/s41467-024-53223-3.
Yoshino T, Di Bartolomeo M, Raghav K, Masuishi T, Loupakis F, Kawakami H, Yamaguchi K, Nishina T, Wainberg Z, Elez E, Rodriguez J, Fakih M, Ciardiello F, Saxena K, Kobayashi K, Bako E, Okuda Y, Meinhardt G, Grothey A, Siena S; DESTINY-CRC01 investigators. Final results of DESTINY-CRC01 investigating trastuzumab deruxtecan in patients with HER2-expressing metastatic colorectal cancer. Nat Commun. 2023 Jun 7;14(1):3332. doi: 10.1038/s41467-023-38032-4.
Siena S, Di Bartolomeo M, Raghav K, Masuishi T, Loupakis F, Kawakami H, Yamaguchi K, Nishina T, Fakih M, Elez E, Rodriguez J, Ciardiello F, Komatsu Y, Esaki T, Chung K, Wainberg Z, Sartore-Bianchi A, Saxena K, Yamamoto E, Bako E, Okuda Y, Shahidi J, Grothey A, Yoshino T; DESTINY-CRC01 investigators. Trastuzumab deruxtecan (DS-8201) in patients with HER2-expressing metastatic colorectal cancer (DESTINY-CRC01): a multicentre, open-label, phase 2 trial. Lancet Oncol. 2021 Jun;22(6):779-789. doi: 10.1016/S1470-2045(21)00086-3. Epub 2021 May 4.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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2017-003466-28
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
173808
Identifier Type: REGISTRY
Identifier Source: secondary_id
DESTINY-C01
Identifier Type: OTHER
Identifier Source: secondary_id
DS8201-A-J203
Identifier Type: -
Identifier Source: org_study_id