RECRUITING

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

Conditions

Advanced Cancer Metastatic Cancer T-DXd DS8201a

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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).

Official Title

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

Quick Facts

Study Start:2024-01-05

Study Completion:2026-08-03

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06174987

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.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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

Inclusion Criteria

Exclusion 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

Contacts and Locations

Study Contact

Daiichi Sankyo Contact for Clinical Trial Information

CONTACT

908-992-6400

CTRinfo@dsi.com

Principal Investigator

Global Clinical Leader

STUDY_DIRECTOR

Daiichi Sankyo

Study Locations (Sites)

Miami Cancer Institute

Miami, Florida, 33176

United States

Duke University - Trent Center

Durham, North Carolina, 27710

United States

Collaborators and Investigators

Sponsor: Daiichi Sankyo

Global Clinical Leader, STUDY_DIRECTOR, Daiichi Sankyo

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-01-05

Study Completion Date2026-08-03

Study Record Updates

Study Start Date2024-01-05

Study Completion Date2026-08-03

Terms related to this study

Keywords Provided by Researchers

Advanced cancer
Metastatic cancer
T-DXd
DS8201a

Additional Relevant MeSH Terms

Advanced Cancer
Metastatic Cancer