Study on Maintenance Olaparib for Advanced Ovarian Cancer Patients Without BRCA Mutation but With Homologous Recombination Deficiency

Sponsor: Alexander B Olawaiye, MD

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT06120972

Provider View

This clinical trial is exploring the effectiveness of using the drug olaparib as a maintenance treatment after initial chemotherapy in patients with advanced ovarian cancer who do not have a BRCA mutation but have a specific genetic deficiency known as homologous recombination deficiency (HRD).

Patient Parameters

Program Overview

The study aims to determine if olaparib, a medication used after initial chemotherapy, can help control advanced ovarian cancer in patients who do not have a BRCA mutation but have homologous recombination deficiency (HRD). This group of patients may benefit from olaparib, even though they do not have the BRCA mutation. The study will provide important information on whether olaparib alone is effective for these patients, as previous studies have shown benefits when olaparib is combined with another drug, bevacizumab.

Description

Olaparib is a type of drug known as a PARP inhibitor, which has changed how we treat ovarian cancer patients with BRCA mutations. However, some patients without BRCA mutations also have genetic changes that make them similar to those with BRCA mutations. These changes are called homologous recombination deficiencies (HRD) and include mutations like BRIP1, RAD51C/D, and CHEK2, as well as changes in gene expression like BRCA methylation. This study is designed to see if patients with these HRD changes, but without BRCA mutations, can benefit from olaparib as a maintenance treatment after their initial chemotherapy. Previous research (PAOLA-1 study) showed that adding olaparib to bevacizumab improved outcomes for these patients, but it is not clear if olaparib alone can provide similar benefits. This study aims to fill that gap and determine if olaparib alone is a good option for these patients. It is already standard practice for patients with HRD to receive maintenance treatment with PARP inhibitors, either alone or with bevacizumab, so this study will not deprive patients of any potentially beneficial treatments.

Eligibility Criteria

Inclusion Criteria

  • Must have a performance status score of 0, 1, or 2, indicating good overall health.
  • Expected to live for at least 16 months.
  • Normal organ and bone marrow function, as shown by specific blood tests.
  • Diagnosed with advanced ovarian cancer without BRCA mutation but with homologous recombination deficiency (HRD).
  • Have measurable cancer that can be tracked using scans or physical exams.
  • At least one tumor that can be accurately measured and monitored over time.

Exclusion Criteria

  • Previously participated in this study.
  • Took part in another clinical trial with an experimental drug in the last 3 months.
  • Have a BRCA 1 or 2 gene mutation.
  • Used a specific type of chemotherapy called hyperthermic intraperitoneal chemotherapy.
  • Have ovarian cancer of a non-epithelial origin or low malignant potential.
  • Have another type of cancer within the last 5 years, except for certain skin or cervical cancers.
  • Have a history of certain blood disorders or prolonged recovery from chemotherapy.
  • Received any systemic chemotherapy or radiotherapy within 3 weeks before starting the study.
  • Had major surgery within 4 weeks before starting the study.
  • Previously received a bone marrow transplant or certain types of blood transfusions.
  • Have taken a PARP inhibitor before, including olaparib.
  • Are taking certain medications that could interfere with the study drug.
  • Have significant heart disease or recent heart attack.
  • Have a history of stroke or bleeding disorders within the last 6 months.
  • Have untreated brain metastases or spinal cord compression.
  • Have significant neurological disorders or recent traumatic injury.
  • Are pregnant or breastfeeding.
  • Have difficulty swallowing pills or have gastrointestinal issues that affect drug absorption.
  • Have a known allergy to olaparib or its ingredients.
  • Have active infections or are immunocompromised.
  • Have uncontrolled medical conditions or psychiatric disorders that could interfere with the study.

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