A Study of Long-Term Responders on Olaparib

Titre officiel

A Retrospective/Prospective Analysis of Characterization of the Long-Term Responders on Olaparib in Solid Tumours

Sommaire:

Cette étude d'observation et de prélèvement d'échantillons porte sur des patients (vivants ou décédés) issus de plusieurs essais cliniques et ayant reçu de l'olaparib, le médicament expérimental, dans d'autres études de recherche. Elle ne prévoit aucune intervention. La recherche vise à comprendre le mécanisme en jeu chez les patients dont le cancer réagit bien à l'olaparib et chez ceux dont le cancer n'y réagit pas bien, afin de mieux définir le mode de fonctionnement de ce médicament expérimental et de mieux recenser les patients pouvant tirer avantage de cette thérapie.

Description de l'essai

Primary Outcome:

  • The number of patients with somatic BRCA mutations compared to number of patients without somatic BRCA mutations
  • The number of patients with homologous recombination repair deficiencies compared to the number of patients that do not have homologous recombination repair deficiencies.
  • The number and types of mutated genes.
  • The number of patients with antibodies to the study drug
  • Evaluate the levels of PI3K/Akt pathway expression per patient
Secondary Outcome:
  • HRR deficiency profile
  • Level of poly (ADP-ribose) (PAR) expression
  • Signature of PARP response compared with signature of platinum sensitivity
  • Signature of PARP response and PARP resistance on different tumour sites
This is study will compare biomarker research with response in patients who have received olaparib. Patients who have had a durable response to olaparib for at least 2 years will be approached for the study. Patients who agree to this study will then have their medical history collected and will be asked to complete a questionnaire. Archival tumour tissue will also be collected for biomarker research. A waiver of consent is requested to access the medical records and archival tumour tissue of patients who are deceased. If participants are still taking olaparib, they will be asked to provide blood samples for pharmacokinetics and circulating tumour DNA, and the results of CT scans taken as part of their standard of care or as a part of another research study. If participants' disease worsens while still on olaparib, they will then be asked to provide a blood sample for pharmacogenomics and BRCA testing (if not known). An optional tumour biopsy will also be requested. Participants will continue to be followed by telephone for survival and any new treatments they are receiving.

Voir cet essai sur ClinicalTrials.gov

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Société canadienne du cancer

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