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

Conditions

• Advanced Cancers Harbouring Mutations in HRG

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Olaparib Oral Capsule — DRUG
  Olaparib tablets 300mg twice daily

Study Details

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.

Key Dates

Start date

Feb 7, 2019

Status verified

Aug 2024

Primary completion

Dec 31, 2024

Completion

Dec 31, 2025

Study Design

Enrollment

540 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Olaparib
  tablets of 300mg twice daily until disease progression

Primary Outcome Measure

Response rate according to RECIST 1.1 [ Time Frame: every 2 months from date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months ]