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
février 2028
27 octobre 2026
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.
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
Participants must meet all of the following criteria to be eligible for enrollment into
the study:
1. Currently enrolled in a DS or DS/AZ-sponsored parent study that has met EOS
definition.
2. No evidence of progressive disease at screening and determined to have
investigator-assessed clinical benefit from continued treatment with a DS or DS/AZ
alliance study drug(s).
3. Male and female subjects of reproductive/childbearing potential must agree to use a
highly effective form of contraception or avoid intercourse during and upon
completion of the study and for at least 7 months for females and 4 months for males
after the last dose of study drug.
a. If the participant is a female of childbearing potential, she must have a
negative urine pregnancy test at Screening, during the Treatment Period, and for 7
months, following the last dose of study drug.
4. Male subjects must not freeze or donate sperm starting at Screening, throughout the
study period, and at least 4 months after the final study drug administration.
5. Female subjects must not donate, or retrieve for their own use, ova from the time of
Screening, and throughout the Treatment Period in the compound-specific sub-protocol
and for at least 7 months after the final study drug administration. They should
refrain from breastfeeding throughout this time.
Exclusion Criteria:
Participants who meet any of the following criteria will be disqualified from entering
the study:
1. Participants who permanently discontinued from the study drug in the parent study.
2. Any AE, laboratory abnormality, or intercurrent illness that, in the opinion of the
investigator, indicates study participation is not in the best interest of the
subject.
3. Local access to commercially available drug at no cost to the subject as permitted
by local/country regulation.