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

Sponsor: Daiichi Sankyo

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT06174987

Patient View

This open-label, multicenter rollover study provides continued treatment for participants benefiting from DS or DS/AZ-sponsored therapies. Eligible participants must have completed a parent study, show no disease progression, and have clinical benefit. T-DXd (DS8201a) is administered via IV infusion every 21 days. The study includes sub-protocols for various study drugs.

Patient Parameters

Program Overview

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).

Description

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.

Eligibility Criteria

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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