Clinical Trial

Efficacy of Olaparib in Advanced Cancers Occurring in Patients With Germline Mutations or Somatic Tumor Mutations in Homologous Recombination Genes

Study acronym: 1-2018 BSMO
Active, Not Recruiting Phase 2
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Record status
This record was last updated August 19, 2024 (before its estimated December 31, 2024 completion). Its status may not reflect the trial's current state.
Summary
At present targeted therapy with the PARP inhibitor olaparib has become standard of care in advanced platinum sensitive BRCA1/2 mutant ovarian cancer. The key in this sensitivity is the loss of homologous recombination (HR) function. The current project aims to treat patients with any type of cancer carrying in their germline a mutation in genes that generate such an homologous recombination deficiency (HRD) or have an acquired somatic mutation in their tumor with the targeted PARP inhibitor olaparib. The project would thus bring access to a targeted drug matched to the genomic profile of the tumor of these patients and provide oncologists with information regarding efficacy and safety of olaparib in these patients. This evidence could then later lead to a more routine regulatory access.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2019-05-29; most recent amendment 2024-08-16.
Status change: Recruiting → Active, Not Recruiting 2024-08-16
Trial Details
NCT Number NCT03967938
Lead Sponsor Universitair Ziekenhuis Brussel
Collaborators: AstraZeneca, Kom Op Tegen Kanker
Conditions Advanced Cancers Harbouring Mutations in HRG
Enrollment 540 participants
Start Date 2019-02-07
Primary Completion 2024-12-31 (estimated)
Study Completion 2025-12-31 (estimated)
Updated on ClinicalTrials.gov 2024-08-19