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

Part of paid clinical trials in Miami, Florida.

Sponsor
Daiichi Sankyo
Study ID
NCT06174987
Phase
PHASE3
Status
Recruiting
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Conditions

  • Advanced Cancer
  • Metastatic Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • T-DXd — DRUG
    T-DXd (DS8201a) will be administered as an intravenous (IV) infusion, on Day 1 of each 21-day cycle according to the dosage regimens

Study Details

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).

Key Dates

Start date
Jan 5, 2024
Status verified
Oct 2025
Primary completion
Aug 3, 2026
Completion
Jan 17, 2028

Study Design

Enrollment
50 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

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) [ Time Frame: 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 ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Miami Cancer InstituteMiamiFlorida33176-
Duke University - Trent CenterDurhamNorth Carolina27710-

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By research site
Miami Cancer Institute· Miami, FLDuke University - Trent Center· Durham, NC

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