NCT06120972

Upfront Maintenance Olaparib in Advanced Ovarian Cancer BRCAwt Patients With Known Homologous Recombination Deficiency

A Non-randomized Prospective Phase II Study of Upfront Maintenance Olaparib in Advanced Ovarian Cancer BRCAwt Patients With Known Homologous Recombination Deficiency

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Alexander B Olawaiye, MD · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective non-randomized efficacy trial of olaparib maintenance therapy after frontline treatment with platinum-based therapy in advanced ovarian cancer patients with BRCAwt, homologous recombination deficient (HRD) disease.

Detailed description

The use of PARP inhibitors has revolutionized how we think of the BRCA mutated population of ovarian cancer patients. However, this population with BRCA mutation is not the only one with homologous recombination deficiencies (HRD). Examples of BRCAwt but HR deficient mutations (HRD) include: BRIP1, RAD51C/D, and CHEK2 as well as epigenetic changes like BRCA methylation. This study is designed to provide information on if BRCAwt, HRD patients with advanced ovarian cancer benefit from maintenance olaparib monotherapy after frontline treatment. PAOLA-1 showed that this population had improved PFS from the addition of olaparib to bevacizumab but there is currently no information on how this population does with olaparib alone. For this reason, a similar population to PAOLA-1 will be used in this study. This study is designed to fill an important gap in the data provided by PAOLA-1. It is now considered standard of care for patients with BRCAwt, HRD disease to receive maintenance PARPi either alone (e.g. niraparib) based of PRIMA or in combination with bevacizumab based of PAOLA-1. Therefore, there is little to no concern that patients will be missing out on potentially beneficial therapy that could impact their prognosis.

Conditions

• Ovarian Cancer

Interventions

Type	Name	Description
DRUG	Olaparib tablet	Lynparza, is a medication for the maintenance treatment of BRCA-mutated advanced ovarian cancer in adults. It is a PARP inhibitor, inhibiting poly ADP ribose polymerase, an enzyme involved in DNA repair.

Timeline

• Start date: 2024-01-17
• Primary completion: 2027-12-31
• Completion: 2029-12-31
• First posted: 2023-11-07
• Last updated: 2025-02-12

Regulatory

• FDA-regulated drug study