Clinical Trials List
Protocol NumberROMast-001
NCT Number(ClinicalTrials.gov Identfier)NCT06174987
Not yet recruiting
2024-02-01 - 2028-04-15
Others
Recruiting2
ICD-10C18.8
Malignant neoplasm of overlapping sites of colon
ICD-10Z51.12
Encounter for antineoplastic immunotherapy
ICD-9153.8
Malignant neoplasm of other specified sites of large intestine
A Master Rollover Study to Provide Continued Access to and Assess Long-Term Safety of the Study Drug(s)
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Trial Applicant
IQVIA RDS Taiwan Ltd.
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Sponsor
-
Trial scale
Multi-Regional Multi-Center
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Update
2026/02/01
Investigators and Locations
Principal Investigator
Co-Principal Investigator
- Chun-Hui Lee Division of Hematology & Oncology
- Peng-Chan Lin Division of Hematology & Oncology
- Wei-Pang Chung Division of Hematology & Oncology
- 黃怡菁 Division of Hematology & Oncology
- Yu-Min Yeh Division of Hematology & Oncology
- 楊舜如 Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Wei-Wu Chen Division of Hematology & Oncology
- YEN-SHEN LU Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
colorectal cancer
Objectives
The primary purpose is to provide treatment to subjects who continue to achieve clinical benefit from investigational drug-based treatment and to continue to monitor the long-term safety of continued treatment with the investigational drug.
Test Drug
Trastuzumab deruxtecan
Active Ingredient
Trastuzumab deruxtecan
Dosage Form
Lyophilized powder for injection
Dosage
100
Endpoints
TEAEs, treatment-emergent serious adverse events (TESAEs), and treatment-emergent adverse events of special interest (AESIs) leading to discontinuation and/or dose reduction of study drug.
Inclution Criteria
Inclusion Criteria:
-Signed informed consent form, prior to the start of any study-specific qualification procedures and willing to comply with all study requirements.
-Currently enrolled in a DS or DS/AZ-sponsored parent study that has met EOS definition.
-No evidence of progressive disease and determined to have investigator-assessed clinical benefit from continued treatment with a DS or DS/AZ alliance study drug(s).
-Signed informed consent form, prior to the start of any study-specific qualification procedures and willing to comply with all study requirements.
-Currently enrolled in a DS or DS/AZ-sponsored parent study that has met EOS definition.
-No evidence of progressive disease and determined to have investigator-assessed clinical benefit from continued treatment with a DS or DS/AZ alliance study drug(s).
Exclusion Criteria
Exclusion Criteria:
-Participants with any unresolved/ongoing AE(s) that meets the study drug discontinuation criteria
-Participant who has been off T-DXd therapy for >18 weeks (126 days) between the last dose from the parent study and the initiation of study drug administration on this study
-Participants with any unresolved/ongoing AE(s) that meets the study drug discontinuation criteria
-Participant who has been off T-DXd therapy for >18 weeks (126 days) between the last dose from the parent study and the initiation of study drug administration on this study
The Estimated Number of Participants
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Taiwan
5 participants
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Global
150 participants
