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

Description

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

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Study Overview

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Study Details

Study 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).

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

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

Condition
Advanced Cancer
Intervention / Treatment

-

Contacts and Locations

Miami

Miami Cancer Institute, Miami, Florida, United States, 33176

Durham

Duke University - Trent Center, Durham, North Carolina, United States, 27710

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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).
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Daiichi Sankyo,

Global Clinical Leader, STUDY_DIRECTOR, Daiichi Sankyo

Study Record Dates

2026-08-03