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A Study to Provide Continued Access to and Assess Long-Term Safety of the Study Drug(s)

PHASE3RECRUITING

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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Study details:

This Master Rollover Study includes sub-protocols with different study drugs. This Master Rollover Protocol describes core study elements that are applicable to all study drugs that will be provided under the Rollover Study.

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Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

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).
  • 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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    Eligibility

    Age eligible for study : 18 and older

    Healthy volunteers accepted : No

    Gender eligible for study: All

    Things to know

    Study dates

    Study start: 2024-01-05

    Primary completion: 2026-08-03

    Study completion finish: 2026-08-03

    study type

    Study type

    TREATMENT

    phase

    Phase

      PHASE3

    trial

    Trial ID

    NCT06174987

    Intervention or treatment

    DRUG: T-DXd

    Conditions

    • Advanced Cancer
    • Metastatic Cancer

    Find a site

    Closest Location:

    Flinders Medical Center

    Research sites nearby

    Select from list below to view details:

    • Flinders Medical Center

      Bedford Park, Not Specified, Australia

    • Monash Medical Center

      Melbourne, Not Specified, Australia

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    Study Plan

    This section provides details of the study plan, including how the study is designed and what the study is measuring.

    How is the study designed?

    Participant Group/ArmIntervention/Treatment
    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.
    DRUG: 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

    What is the study measuring?

    Primary outcome

    Primary Outcome MeasurePrimary Outcome DescriptionPrimary Outcome Time Frame
    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)Not SpecifiedBaseline 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

    Secondary outcome

    Frequently Asked Questions

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    References

    Clinical Trials Gov: A Study to Provide Continued Access to and Assess Long-Term Safety of the Study Drug(s)

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