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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/NCT05301972
Registration number
NCT05301972
Ethics application status
Date submitted
16/11/2021
Date registered
31/03/2022
Date last updated
14/10/2022
Titles & IDs
Public title
Expanded Access for Bromodomain and Extra-Terminal (BET) Inhibitor
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Scientific title
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Secondary ID [1]
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CA011-011
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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:
Condition category
Condition code
Intervention/exposure
Study type
Expanded Access
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Description of intervention(s) / exposure
Treatment: Drugs - BET Inhibitor
Treatment: Drugs: BET Inhibitor
Bromodomain and Extra-Terminal Inhibitor
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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
Eligibility
Key inclusion criteria
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Minimum age
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Maximum age
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Sex
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Can healthy volunteers participate?
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Key exclusion criteria
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Study design
Purpose of the study
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Allocation to intervention
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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
Blinded (masking used)
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Who is / are masked / blinded?
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Intervention assignment
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Other design features
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Phase
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
No longer available
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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
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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
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Actual
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Sample size
Target
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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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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Bristol-Myers Squibb
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
This is an expanded access designed to provide access to Bromodomain and Extra-Terminal (BET)
Inhibitor for eligible participants.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT05301972
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Trial related presentations / publications
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Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed
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Contacts
Principal investigator
Name
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Bristol-Myers Squibb
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Address
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Bristol-Myers Squibb
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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
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Address
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT05301972
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