Outcomes of First-line Olaparib Mono-maintenance therapy-a Multicenter, Retrospective Study Using Data From Real-world Clinical Setting

Sponsor
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Study ID
NCT05153603
Status
Unknown

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Olaparib mono-maintenance therapy — DRUG
    Olaparib mono-maintenance therapy in patients with newly diagnosed, histologically confirmed, advanced (FIGO stage III-IV) ovarian cancer, primary peritoneal cancer and / or fallopian-tube cancer is defined as drug exposure. At least one dose of olaparib tablets monotherapy as maintenance therapy will be required.

Study Details

Four phase III trials in ovarian cancer consistently showed that front-line poly(ADP-ribose) polymerase (PARP) inhibition can significantly improve progression-free survival. Based on these findings, current clinical guidelines recommend the olaparib + bevacizumab combination as a maintenance therapy for ovarian cancer patients with BRCA1/2 wild-type or unknown mutation status who have a complete response (CR)/ partial response (PR) after completing bevacizumab-containing first-line therapy. However, bevacizumab is not a NATIONAL MEDICAL PRODUCTS ADMINSTRATION（NMPA）-approved agent for ovarian cancer patients. In this setting, olaparib mono-maintenance therapy has been implemented among patients with BRCA-wild type tumors in clinical practice in China.

Key Dates

Start date
Apr 30, 2022
Status verified
Dec 2021
Primary completion
Sep 30, 2022
Completion
Dec 31, 2022

Study Design

Enrollment
50 participants (estimated)

Arms

  • Arm: Olaparib mono-maintenance therapy group
    Olaparib monotherapy in clinical practice and will be conducted in patients with tBRCAwt newly diagnosed high grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete response or partial response) to platinum-based chemotherapy following the standard of care from Aug 2018 up to Dec 2020 (the time range could be extended in order to recruit enough eligible subjects as required) at tertiary-referral university hospitals and main cancer centers in China.

Primary Outcome Measure

1-yr PFS rate [ Time Frame: 12 months after date of first dose ]

Central Contacts

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