A Phase 2 study of T-DXd in Patients with Selected HER2 Expressing Tumors - DPT02
Study identifier:D967VC00001
ClinicalTrials.gov identifier:NCT04482309
EudraCT identifier:N/A
CTIS identifier:N/A
Recruitment Complete
Official Title
A Phase 2, Multicenter, Open-label Study to Evaluate the Efficacy and Safety of Trastuzumab Deruxtecan (T-DXd, DS-8201a) for the Treatment of Selected HER2 Expressing Tumors (DESTINY-PanTumor02)
Medical condition
Bladder cancer, Biliary tract cancer, Cervical cancer, Endometrial cancer, Ovarian cancer, Pancreatic cancer, Rare tumors
Phase
Phase 2
Healthy volunteers
No
Study drug
Trastuzumab deruxtecan
Sex
All
Actual Enrollment
268
Study type
Interventional
Age
18 Years - 120 Years
Date
Study Start Date: 18 Aug 2020
Estimated Primary Completion Date: 16 Jun 2023
Estimated Study Completion Date: 16 Jun 2023
Study design
Allocation: Non-randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Treatment
Verification:
Verified 01 Feb 2023 by AstraZeneca
Sponsors
AstraZeneca
Collaborators
Daiichi Sankyo Co., Ltd.
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: Arm 1 Cohort 1: Biliary tract cancer | Drug: Trastuzumab deruxtecan Trastuzumab deruxtecan by intravenous infusion Other Name: DS-8201a Other Name: T-DXd |
| Experimental: Arm 2 Cohort 2: Bladder cancer | Drug: Trastuzumab deruxtecan Trastuzumab deruxtecan by intravenous infusion Other Name: DS-8201a Other Name: T-DXd |
| Experimental: Arm 3 Cohort 3: Cervical cancer | Drug: Trastuzumab deruxtecan Trastuzumab deruxtecan by intravenous infusion Other Name: DS-8201a Other Name: T-DXd |
| Experimental: Arm 4 Cohort 4: Endometrial cancer | Drug: Trastuzumab deruxtecan Trastuzumab deruxtecan by intravenous infusion Other Name: DS-8201a Other Name: T-DXd |
| Experimental: Arm 5 Cohort 5: Ovarian cancer | Drug: Trastuzumab deruxtecan Trastuzumab deruxtecan by intravenous infusion Other Name: DS-8201a Other Name: T-DXd |
| Experimental: Arm 6 Cohort 6: Pancreatic cancer | Drug: Trastuzumab deruxtecan Trastuzumab deruxtecan by intravenous infusion Other Name: DS-8201a Other Name: T-DXd |
| Experimental: Arm 7 Cohort 7: Rare tumors | Drug: Trastuzumab deruxtecan Trastuzumab deruxtecan by intravenous infusion Other Name: DS-8201a Other Name: T-DXd |
