NCT04517357CompletedPhase 2
A Phase 2 Trial of Fluzoparib Combined With Apatinib Versus Fluzoparib Monotherapy in Treatment With Relapsed Ovarian Cancer Patients
A Phase 2 Open Label, Randomised, Controlled, Multi-centre Study to Assess the Efficacy and Safety of Fluzoparib Combined With Apatinib Versus Fluzoparib Monotherapy in the Treatment of Relapsed Ovarian Cancer Patients
Source: ClinicalTrials.gov · Last updated 24 Feb 2025
Brief summary (registry, in English)
This is a multicenter, randomized, open-label, 2-arm Phase 2 study to evaluate the efficacy and safety of Fluzoparib with Apatinib versus Fluzoparib alone, as treatment, in relapsed ovarian cancer patients. The study contains a Safety Lead-in Phase in which the safety and tolerability of Fluzoparib+Apatinib will be assessed prior to the Phase 2 portion of the study.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 100 (actual)
- First submitted
- 16 Aug 2020
- Start date
- 16 Oct 2020
- Primary completion date
- 30 Nov 2023
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Diseases
- Ovarian cancer
- NCT number
- NCT04517357
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 100
- From 16 Oct 2020 to the primary completion date, 30 Nov 2023
- 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 or Apatinib.For exploratory cohort ,patients who received PARP inhibitor are eligible;
- Radiation or anti-hormonal therapy or anticancer therapy within 14 days before first administration;
- Patients with clinical symptoms of cancer ascites, pleural effusion, who need to drainage, or who have undergone ascites drainage within 3 months prior to the first administration;
Other illness
- Known active hepatitis C virus, or known active hepatitis B virus;
Age
- Prior malignancy unless curatively treated and disease-free for \> 5 years prior to study entry. Prior adequately treated non-melanoma skin cancer, in situ cancer of the cervix allowed;
Other
- Known to be human immunodeficiency virus positive;
- Untreated and/or uncontrolled brain metastases;
- Pregnant or breast-feeding women.
Who the study is looking for
- Histologically diagnosed high-grade serous or endometrioid recurrent ovarian,fallopian tube,or peritoneal cancer.
- Patients must have received at least 2 previous platinum-containing regimens.
- At least one target lesion.
- ECOG performance status 0-1.
- Adequate bone marrow, kidney and liver function.
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 |
|---|---|---|---|
| Zhejiang Cancer Hospital Coordinator of this site? Confirm its status | Hangzhou | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.