Informations générales (source: ClinicalTrials.gov)
An Open-Label, Multicenter Extension Study in Patients Previously Enrolled in a Genentech and/or F. Hoffmann-La Roche Ltd Sponsored Study
Interventional
Phase 3
Hoffmann-La Roche (Voir sur ClinicalTrials)
juin 2023
mars 2033
04 octobre 2026
The purpose of this extension study is to provide continued treatment with Roche
investigational medicinal product (IMP[s]) monotherapy or Roche IMP(s) combined with
other agent(s) or comparator agent(s) for eligible participants with cancer who are still
on study treatment at the time of roll-over from the parent study and who do not have
access to the study treatment locally.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT GUSTAVE ROUSSY | Patricia PAUTIER | 01/10/2026 15:45:36 | Contacter | ||
Critères
Tous
- Eligible for continuing Roche IMP-based therapy at the time of roll-over from the
parent study, as per the parent study protocol OR
- Eligible for continuing the comparator agent(s) in a Genentech- or Roche-sponsored
study as per the parent study protocol, with no access to commercially available
comparator agent
- First dose of study treatment in this extension study will be received within 7 days
of the treatment interruption window allowed by the parent study
- Continue to benefit from the Roche IMP-based therapy or comparator at the time of
roll-over from the parent study as assessed by the investigator
- Ability to comply with the extension study protocol, per Investigator's judgement
Exclusion Criteria:
- Meet any of the study treatment discontinuation criteria specified in the parent
study at the time of enrollment in this extension study
- Study treatment or comparator agent is commercially marketed in the participant's
country for the participant-specific disease and is accessible to the participant
- Treatment with any anti-cancer treatment (other than treatment permitted in the
parent study) during the time between last treatment in the parent study and the
first dose of study treatment in this extension study
- Permanent discontinuation of all study treatment(s) or comparator agent(s) for any
reason during the parent study or during the time between last treatment in the
parent study and the first dose of study treatment in this extension study (if
applicable)
- Ongoing SAE(s) that has not resolved to baseline level or Grade ≤1 from the parent
study or during the time between the last treatment in the parent study and the
first dose of study treatment in this extension study
- Concurrent participation in any therapeutic clinical trial (other than the parent
study)