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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06174987




Registration number
NCT06174987
Ethics application status
Date submitted
8/12/2023
Date registered
18/12/2023

Titles & IDs
Public title
A Study to Provide Continued Access to and Assess Long-Term Safety of the Study Drug(s)
Scientific title
A Master Rollover Study to Provide Continued Access to and Assess Long-Term Safety of the Study Drug(s)
Secondary ID [1] 0 0
2023-506330-73-00
Secondary ID [2] 0 0
ROMast-001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Advanced Cancer 0 0
Metastatic Cancer 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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)
Timepoint [1] 0 0
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

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).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
NA
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
5/01/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
3/08/2026
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Flinders Medical Center - Bedford Park
Recruitment hospital [2] 0 0
Monash Medical Center - Melbourne
Recruitment postcode(s) [1] 0 0
5042 - Bedford Park
Recruitment postcode(s) [2] 0 0
3168 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Florida
Country [2] 0 0
United States of America
State/province [2] 0 0
North Carolina
Country [3] 0 0
Belgium
State/province [3] 0 0
Charleroi
Country [4] 0 0
France
State/province [4] 0 0
Villejuif
Country [5] 0 0
Italy
State/province [5] 0 0
Milano
Country [6] 0 0
Italy
State/province [6] 0 0
Napoli
Country [7] 0 0
Japan
State/province [7] 0 0
Chuo city
Country [8] 0 0
Korea, Republic of
State/province [8] 0 0
Daegu
Country [9] 0 0
Korea, Republic of
State/province [9] 0 0
Gyeonggi-do
Country [10] 0 0
Korea, Republic of
State/province [10] 0 0
Jongno-gu
Country [11] 0 0
Korea, Republic of
State/province [11] 0 0
Seoul
Country [12] 0 0
Spain
State/province [12] 0 0
A Coruña
Country [13] 0 0
Spain
State/province [13] 0 0
Barcelona
Country [14] 0 0
Spain
State/province [14] 0 0
Distrito De Les Corts
Country [15] 0 0
Spain
State/province [15] 0 0
L'Hospitalet de Llobregat
Country [16] 0 0
Spain
State/province [16] 0 0
Madrid
Country [17] 0 0
Taiwan
State/province [17] 0 0
Tainan
Country [18] 0 0
Taiwan
State/province [18] 0 0
Taipei
Country [19] 0 0
United Kingdom
State/province [19] 0 0
Guildford

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Daiichi Sankyo
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
AstraZeneca
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Global Clinical Leader
Address 0 0
Daiichi Sankyo
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Daiichi Sankyo Contact for Clinical Trial Information
Address 0 0
Country 0 0
Phone 0 0
908-992-6400
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified individual participant data (IPD) on completed studies and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Informed consent form (ICF)
When will data be available (start and end dates)?
Completed studies that has reached a global end or completion with all data set collected and analyzed, and for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.
Available to whom?
Formal request from qualified scientific and medical researchers on IPD and clinical study documents on completed clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://vivli.org/ourmember/daiichi-sankyo/


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06174987