Clinical Trials - DataSource by Daiichi Sankyo

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

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).

CONDITIONS

Advanced Cancer, Metastatic Cancer

PRODUCT

T-DXd

GENDER

ALL

AGE

18 Years

SPONSOR

Daiichi Sankyo

COLLABORATOR

AstraZeneca

TRIAL RUNS IN

28 Global Locations

Trial Summary

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.

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

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).

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

This was last updated on 2025-11-06 19:34:44.552.

The content contained is taken is taken directly from public registry ClinicalTrials.gov and has not been edited.

Information about pipeline compounds or investigational uses of compounds does not imply FDA approval for these compounds or uses, nor does it establish the safety or efficacy of these compounds or uses. There is no guarantee that the pipeline compounds or investigational uses will receive FDA approval. Daiichi Sankyo does not recommend or suggest use of its medicines in a manner inconsistent with FDA-approved labeling.