NCT03863860CompletedPhase 3
A Trial of Maintenance Treatment With Fluzoparib Versus Placebo in Relapsed Ovarian Cancer Patients
A Phase 3 Randomized, Double-blind, Placebo-controlled, Multicenter Trial of Maintenance Treatment With Fluzoparib Capsules Versus Placebo in Patients With Platinum-sensitive Recurrent Ovarian Cancer
Source: ClinicalTrials.gov · Last updated 3 Jul 2025
Brief summary (registry, in English)
To evaluate the efficacy, safety tolerability of maintenance therapy with Fluzoparib(A PARP inhibitor) versus placebo in Chinese patients with recurrent ovarian cancer who achieved a complete response (CR) or partial response (PR) after platinum-based chemotherapy
- Status (registry)
- Completed
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 252 (actual)
- First submitted
- 25 Feb 2019
- Start date
- 30 Apr 2019
- Primary completion date
- 10 Jan 2022
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Diseases
- Ovarian cancer
- NCT number
- NCT03863860
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 252
- From 30 Apr 2019 to the primary completion date, 10 Jan 2022
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior treatment with a poly (ADP-ribose) polymerase (PARP) inhibitor
- Patients who have received other study drug treatment within 4 weeks prior to the first administration(\< 5 elimination half-lives of the study drug molecular targeted anti-cancer drugs).
- Patients with clinical symptoms of cancer ascites, pleural effusion, who need to drainage, or who have undergone ascites drainage within 2 months prior to the first administration.
Who the study is looking for
- Histologically diagnosed high-grade serous or endometrioid ovarian cancer (including primary peritoneal and fallopian tube cancer)
- Completion of ≥2 previous platinum-containing regimens
- Complete response (CR) or partial response (PR) achieved with last platinum-based chemotherapy regimen as determined by investigator
- Ability to be randomized ≤8 weeks after last dose of platinum
Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Cancer Hospital, Chinese Academy of Medical Sciences Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.