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Genital Diseases

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Ovarian Cancer

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Olaparib

Poly(ADP-ribose) Polymerase Inhibitors

Enzyme Inhibitors

300 mg Olaparib (tablets) will be taken orally, twice a day (approximately every twelve hours)

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.

Olaparib tablet

Kelsey Mitch, RN

Joshua Plassmeyer, MS

Alexander B Olawaiye, MD

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.

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.

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

Time (median number of months) between enrolment and progression (defined by RECIST 1.1) or death, whichever occurs first, and censored at the last date of disease assessment in the absence of progressive disease. Per RECISIT v1.1: Progressive Disease (PD):≥20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). The sum must also demonstrate an absolute increase of ≥5 mm. The appearance ≥1 new lesion(s) is considered progression.

Percentage of participants free of disease progression at 1 year. Per RECISIT v1.1: Progressive Disease (PD):≥20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). The sum must also demonstrate an absolute increase of ≥5 mm. The appearance ≥1 new lesion(s) is considered progression.

Time (median number of months) between enrollment and progression or death, whichever occurs first, and censored at the last date of disease assessment in the absence of progressive disease. Per RECISIT v1.1: Progressive Disease (PD):≥20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). The sum must also demonstrate an absolute increase of ≥5 mm. The appearance ≥1 new lesion(s) is considered progression.

Time (median number of months) between enrollment and second objective disease progression, or death from any cause, whichever occurs first, and censored at last date of disease assessment in the absence of second disease progression. Per RECISIT v1.1: Progressive Disease (PD):≥20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). The sum must also demonstrate an absolute increase of ≥5 mm. The appearance ≥1 new lesion(s) is considered progression.

Time (median number of months) from enrolment to death from any cause and censored at date of last follow-up.

The EORTC QLQ-C30 is a cancer-specific questionnaire assessing 15 health-related quality of life (HRQoL) scales through 30-items: a global health status, five functional scales (physical, role, emotional, cognitive, and social) and nine symptomatic scales (fatigue, nausea and vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). For each dimension, one score is generated on a 0-100 scale, with higher score representing better HRQoL. Minimal clinically important difference defined as ±10 points.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Upfront Maintenance Olaparib in Advanced Ovarian Cancer BRCAwt Patients With Known Homologous Recombination Deficiency	NCT06120972	Ovarian Cancer	Olaparib tablet	18 Years -	University of Pittsburgh
Upfront Maintenance Olaparib in Advanced Ovarian Cancer BRCAwt Patients With Known Homologous Recombination Deficiency	NCT06120972	Ovarian Cancer	Olaparib tablet	18 Years -	University of Pittsburgh

Spots Global Cancer Trial Database for homologous recombination repair (hr)