MedTrace Logo

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

NCT03967938 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 540

Last updated 2024-08-19

No results posted yet for this study

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.

Conditions

  • Advanced Cancers Harbouring Mutations in HRG

Interventions

DRUG

Olaparib Oral Capsule

Olaparib tablets 300mg twice daily

Sponsors & Collaborators

  • AstraZeneca

    collaborator INDUSTRY

  • Kom Op Tegen Kanker

    collaborator OTHER

  • AZ-VUB

    lead OTHER

Principal Investigators

  • Sofie Joris, Dr · Universitair Ziekenhuis Brussel

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-02-07
Primary Completion
2024-12-31
Completion
2025-12-31

Countries

  • Belgium

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03967938 on ClinicalTrials.gov