Informations générales (source: ClinicalTrials.gov)
A Master Rollover Study to Provide Continued Access to and Assess Long-Term Safety of the Study Drug(s)
Interventional
Phase 3
Daiichi Sankyo (Voir sur ClinicalTrials)
janvier 2024
août 2026
11 avril 2025
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).
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT GUSTAVE ROUSSY | David PLANCHARD | 05/06/2024 10:59:13 | Contacter | ||
Critères
Tous
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).
- 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