DS-8201a in HER2-positive Gastric Cancer That Cannot Be Surgically Removed or Has Spread (DESTINY-Gastric02)
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ClinicalTrials.gov Identifier: NCT04014075 |
Recruitment Status :
Completed
First Posted : July 10, 2019
Results First Posted : January 12, 2022
Last Update Posted : April 9, 2024
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Sponsor:
Daiichi Sankyo
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
Daiichi Sankyo
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Study Type | Interventional |
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Study Design | Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment |
Conditions |
Adenocarcinoma Gastric Stage IV With Metastases Adenocarcinoma - GEJ |
Intervention |
Drug: Trastuzumab deruxtecan |
Enrollment | 79 |
Participant Flow
Recruitment Details | A total of 79 participants who met all inclusion criteria and no exclusion criteria were enrolled and treated at clinic centers in United States, Spain, Italy, United Kingdom, and Belgium. Results reported is from baseline up to data cut-off date of 08 Nov 2021. The results presented are based on primary analysis up to 16 months (09 Apr 2021) and data cut-off date of 08 Nov 2021. Data collection is still on-going and additional results will be provided after study completion. |
Pre-assignment Details |
Arm/Group Title | Trastuzumab Deruxtecan |
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Arm/Group Description | Participants who have centrally confirmed HER2-positive gastric or gastro-esophageal junction cancer received an intravenous (IV) infusion 6.4 mg/kg dose of trastuzumab deruxtecan every 3 weeks, until progression of disease or withdrawal from treatment for other reasons. |
Period Title: Overall Study | |
Started | 79 |
Completed [1] | 10 |
Not Completed | 69 |
Reason Not Completed | |
Progressive Disease | 48 |
Adverse Event | 11 |
Clinical Progression | 4 |
Death | 2 |
Withdrawal by Subject | 2 |
Miscellaneous | 1 |
Physician Decision | 1 |
[1]
Completed = Participants ongoing treatment as of 08 Nov 2021, Not Completed = Participants who discontinued treatment
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Baseline Characteristics
Arm/Group Title | Trastuzumab Deruxtecan | |
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Arm/Group Description | Participants who have centrally confirmed HER2-positive gastric or gastro-esophageal junction cancer treated with trastuzumab deruxtecan by intravenous (IV) infusion every 3 weeks, until progression of disease or withdrawal from treatment for other reasons. | |
Overall Number of Baseline Participants | 79 | |
Baseline Analysis Population Description |
[Not Specified]
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Age, Categorical
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 79 participants | |
<=18 years |
0 0.0%
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Between 18 and 65 years |
46 58.2%
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>=65 years |
33 41.8%
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Age, Continuous
Median (Full Range) Unit of measure: Years |
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Number Analyzed | 79 participants | |
60.7
(20.3 to 77.8)
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 79 participants | |
Female |
22 27.8%
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Male |
57 72.2%
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Race (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 79 participants | |
American Indian or Alaska Native |
0 0.0%
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Asian |
4 5.1%
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Native Hawaiian or Other Pacific Islander |
1 1.3%
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Black or African American |
1 1.3%
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White |
69 87.3%
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More than one race |
0 0.0%
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Unknown or Not Reported |
4 5.1%
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Region of Enrollment
Measure Type: Number Unit of measure: Participants |
Number Analyzed | 79 participants |
Belgium | 4 | |
United States | 34 | |
Italy | 20 | |
United Kingdom | 17 | |
Spain | 4 |
Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Results Point of Contact
Name/Title: | Contact for Clinical Trial Information |
Organization: | Daiichi Sankyo |
Phone: | 1-908-992-6400 |
EMail: | CTRinfo@dsi.com |
Responsible Party: | Daiichi Sankyo |
ClinicalTrials.gov Identifier: | NCT04014075 |
Other Study ID Numbers: |
DS8201-A-U205 2019-001512-34 ( EudraCT Number ) |
First Submitted: | July 8, 2019 |
First Posted: | July 10, 2019 |
Results First Submitted: | December 14, 2021 |
Results First Posted: | January 12, 2022 |
Last Update Posted: | April 9, 2024 |