Status:
COMPLETED
DS-8201a in HER2-positive Gastric Cancer That Cannot Be Surgically Removed or Has Spread (DESTINY-Gastric02)
Lead Sponsor:
Daiichi Sankyo
Collaborating Sponsors:
AstraZeneca
Conditions:
Adenocarcinoma Gastric Stage IV With Metastases
Adenocarcinoma - GEJ
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This study will find out if trastuzumab deruxtecan is safe and works for participants with gastric or gastroesophageal junction cancer. They must have human epidermal growth factor receptor 2 (HER2)-...
Eligibility Criteria
Inclusion
- Men or women ≥18 years old (local regulatory guidelines apply)
- Has pathologically documented HER2-positive gastric or GEJ cancer that is unresectable or metastatic, and that progressed during or after treatment regimen containing trastuzumab
- Has at least one measurable lesion per RECIST v1.1, as confirmed by investigator review
- If of reproductive potential, agrees to use a highly effective form of contraception or avoid intercourse during and upon completion of the study and for at least 7 months for females and 4 months for males after the last dose of study drug
Exclusion
- Has had anticancer therapy after first-line treatment regimen containing trastuzumab
- Has uncontrolled cardiovascular disease, including any of the following: history of myocardial infarction (MI) within 6 months of first dose or symptomatic congestive heart failure (New York Heart Association Class II to IV), troponin levels consistent with MI as defined according to the manufacturer within 28 days of first dose, or corrected QT interval (QTc) prolongation to \>470 ms (females) or \>450 ms (male) based on screening triplicate 12-lead electrocardiogram (ECG)
- Has history of non-infectious interstitial lung disease (ILD)/pneumonitis that required corticosteroid therapy, or current ILD/pneumonitis that cannot be ruled out at screening
- Clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses including, but not limited to, any underlying pulmonary disorder (ie, pulmonary emboli within 3 months of the first dose, severe asthma, severe chronic obstructive pulmonary disease (COPD), restrictive lung disease, pleural effusion, etc.), and any autoimmune, connective tissue or inflammatory disorders with pulmonary involvement (ie, rheumatoid arthritis, Sjogren's, sarcoidosis, etc.), or prior pneumonectomy.
- Has pleural effusion, ascites, or pericardial effusion that requires drainage, peritoneal shunt, or Cell-free and Concentrated Ascites Reinfusion Therapy (CART)
- Has spinal cord compression or clinically active central nervous system metastases, defined as untreated and symptomatic or requiring therapy with corticosteroids or anticonvulsants to control associated symptoms (Note: participants with clinically inactive brain metastases may be included in the study as well as participants with treated brain metastases who are no longer symptomatic and no longer require treatment with corticosteroids or anticonvulsants.
Key Trial Info
Start Date :
November 26 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 13 2024
Estimated Enrollment :
79 Patients enrolled
Trial Details
Trial ID
NCT04014075
Start Date
November 26 2019
End Date
February 13 2024
Last Update
April 3 2025
Active Locations (37)
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1
City of Hope Medical Center
Duarte, California, United States, 91010
2
USC Norris Comprehensive Cancer Center Hospital
Los Angeles, California, United States, 90033
3
Pacific Cancer Care
Monterey, California, United States, 93940
4
UCLA Health
Santa Monica, California, United States, 90404