Extended Treatment Protocol for Subjects Continuing to Benefit From Ibrutinib.

Titre officiel

Extended Treatment Protocol for Subjects Continuing to Benefit From Ibrutinib After Completion of Ibrutinib Clinical Trials.

Sommaire:

Protocole de traitement multicentrique, ouvert et prospectif offrant un accès continu à l’ibrutinib aux sujets qui ont terminé les études parentes sur l’ibrutinib, qui bénéficient toujours du traitement par l’ibrutinib et qui n’ont pas accès à l’ibrutinib commercial pour leur maladie sous-jacente dans leur région.

Description de l'essai

Primary Outcome:

  • The objective of protocol PCYC-1145-LT is to provide long-term access to ibrutinib for subjects who meet the selection criteria.
Secondary Outcome:
  • Characterize the drug safety profile by collecting long-term safety data for ibrutinib.
Multicentre, open-label, prospective treatment protocol that provides continued access to ibrutinib to subjects who have completed parent ibrutinib studies, are still benefitting from treatment with ibrutinib, and have no access to commercial ibrutinib for their underlying disease within their region. Subjects enrolled in this treatment protocol will receive oral continuous dosing with ibrutinib at the same dose and schedule they were receiving at the end of the respective parent study. Treatment may be continued as long as the subjects continue to derive benefit from treatment with ibrutinib until such time that ibrutinib becomes commercially available for the indication of the parent study. Clinical evaluations (including safety assessments) will be performed per local standard of care for each disease that was studied in the parent protocol. At each visit, all ongoing and new onset non-serious AEs leading to dose reduction or discontinuation, serious adverse events (SAEs), adverse events of special interest (AESI), pregnancy events, other malignancies, and special reporting situations will be recorded.

Voir cet essai sur ClinicalTrials.gov

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