← Back to Clinical Trials
RecruitingPhase 3NCT06174987

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

◆ AI Clinical Summary

This study allows people with advanced cancer who have been helped by Daiichi Sankyo cancer drugs in previous clinical trials to continue receiving their treatment. The study will monitor the long-term safety of these drugs to ensure they remain safe and effective over time.

Key Objective:The trial provides continued access to cancer treatment for patients who have already shown benefit from the study drug without interruption.

Who to Consider:People with advanced cancer who previously participated in and benefited from Daiichi Sankyo or Daiichi Sankyo/Astra Zeneca-sponsored cancer drug studies should consider enrolling.

Trial Parameters

ConditionAdvanced Cancer
SponsorDaiichi Sankyo
Study TypeINTERVENTIONAL
PhasePhase 3
Enrollment50
SexALL
Min Age18 Years
Max AgeN/A
Start Date2024-01-05
Completion2026-08-03
Interventions
T-DXd

Eligibility Fast-Check

Enter your details for a quick preliminary check. This does not replace medical advice.

Brief Summary

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).

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

Related Trials