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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT06174987
Registration number
NCT06174987
Ethics application status
Date submitted
8/12/2023
Date registered
18/12/2023
Date last updated
20/05/2024
Titles & IDs
Public title
A Study to Provide Continued Access to and Assess Long-Term Safety of the Study Drug(s)
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Scientific title
A Master Rollover Study to Provide Continued Access to and Assess Long-Term Safety of the Study Drug(s)
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Secondary ID [1]
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2023-506330-73-00
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Secondary ID [2]
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ROMast-001
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Advanced Cancer
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Metastatic Cancer
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0
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - T-DXd
Experimental: T-DXd - Participants who choose to continue treatment with T-DXd may be enrolled. Participants who were on the comparator arm in the parent study will be provided the option to access the drug through standard of care (SoC) or other available options.
Participants will remain on their current dosage regimen of T-DXd as the last dose administered in the parent study, unless they experience an AE that requires dose reduction at the EOT of the parent study, in which case the starting dose in this study will be the next lower dose-level.
Treatment: Drugs: T-DXd
T-DXd (DS8201a) will be administered as an intravenous (IV) infusion, on Day 1 of each 21-day cycle according to the dosage regimens
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Number of Participants Reporting Treatment-emergent Adverse Events Leading to Study Drug discontinuation and/or Dose Reduction, Treatment-emergent Serious Adverse Events (TESAEs), and Treatment-emergent Adverse Events of Special Interest (AESIs)
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Assessment method [1]
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Timepoint [1]
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Baseline until disease progression, loss of clinical benefit, death, adverse event, pregnancy, withdrawal of consent, access to commercial supply, physician decision, or study closure, whichever occurs first, up to approximately 2 years 9 months
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Eligibility
Key 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).
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
N/A
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
5/01/2024
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
3/08/2026
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Actual
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Sample size
Target
50
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Flinders Medical Center - Bedford Park
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Recruitment hospital [2]
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Monash Medical Center - Melbourne
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Recruitment postcode(s) [1]
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5042 - Bedford Park
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Recruitment postcode(s) [2]
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3168 - Melbourne
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Florida
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Country [2]
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United States of America
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State/province [2]
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North Carolina
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Belgium
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State/province [3]
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Charleroi
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Country [4]
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France
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State/province [4]
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Villejuif
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Country [5]
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Italy
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State/province [5]
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Milano
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Country [6]
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Italy
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State/province [6]
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Napoli
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Country [7]
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Japan
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State/province [7]
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Chuo city
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Country [8]
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Korea, Republic of
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State/province [8]
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Daegu
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Korea, Republic of
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State/province [9]
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Gyeonggi-do
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Country [10]
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Korea, Republic of
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State/province [10]
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Jongno-gu
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Country [11]
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Korea, Republic of
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State/province [11]
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Seoul
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Country [12]
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Spain
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State/province [12]
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A Coruña
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Country [13]
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Spain
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State/province [13]
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Barcelona
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Country [14]
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Spain
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State/province [14]
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Distrito De Les Corts
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Country [15]
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Spain
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State/province [15]
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L'Hospitalet de Llobregat
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Country [16]
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Spain
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State/province [16]
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Madrid
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Country [17]
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Taiwan
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State/province [17]
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Tainan
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Country [18]
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Taiwan
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State/province [18]
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Taipei
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Country [19]
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United Kingdom
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State/province [19]
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Guildford
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Daiichi Sankyo
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Address
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Country
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Other collaborator category [1]
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Commercial sector/Industry
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Name [1]
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AstraZeneca
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Address [1]
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Country [1]
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Ethics approval
Ethics application status
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Summary
Brief summary
This open-label, multicenter, rollover study will provide continued treatment for
participants deriving benefit from different therapies received in studies sponsored by
Daiichi Sankyo, Inc. (DS) or DS/Astra Zeneca (AZ)-sponsored study (eg. DS8201-A-J101,
DS8201-A-U201, DS8201-A-U204, DS8201-A-U207, DS8201-A-U303).
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Trial website
https://clinicaltrials.gov/ct2/show/NCT06174987
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Global Clinical Leader
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Address
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Daiichi Sankyo
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Daiichi Sankyo Contact for Clinical Trial Information
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Address
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Country
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Phone
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908-992-6400
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT06174987
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