Fluzoparib With or Without Apatinib in Platinum-sensitive Relapsed Ovarian Cancer Previously Trea… (NCT06161272) | Clinical Trial Compass
UnknownPhase 2
Fluzoparib With or Without Apatinib in Platinum-sensitive Relapsed Ovarian Cancer Previously Treated With PARPi
China80 participantsStarted 2023-12-10
Plain-language summary
This is a randomized, multicenter, two-arm, noncomparative, phase II study of fluzoparib with or without apatinib for maintenance therapy in PARPi-pretreated platinum-sensitive recurrent ovarian cancer. The primary objective is to evaluate median progression free survival of fluzoparib with or without apatinib.
Who can participate
Age range18 Years – 75 Years
SexFEMALE
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Inclusion criteria
✓. The patient voluntarily joined the study and signed the informed consent.
✓. Female, 18-75 years (calculated on date of signing informed consent).
✓. Participant has histologically confirmed diagnosis of high-grade predominantly serous ovarian cancer, fallopian tube cancer, primary peritoneal cancer; ≥grade II ovarian endometrioid adenocarcinoma.
✓. Disease progression greater than 6 months (184 days) after completion of their last dose of platinum chemotherapy.
✓. Prior treatment with ≥2 platinum-containing chemotherapy regimens and disease remission (complete or partial response) at the end of the last platinum chemotherapy, which lasted until study administration, must be randomized to enrollment and start trial drug administration within 8 weeks from the last chemotherapy administration.
✓. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
✓. The duration of continuous PARPi treatment during the previous maintenance treatment period was ≥6 months.
✓. Participant has adequate organ function as defined in the following contents (Any blood component or cell growth factor within 14 days prior to randomization is not permitted)
Exclusion criteria
✕. 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 or breast cancer without recurrence over 3 years allowed.
. The expected survival is less than three months.
✕. Participants with untreated central nervous system metastases
✕. Not able to swallow pills normally, or have abnormal gastrointestinal function affecting drug absorption as judged by the researcher.
✕. Intestinal obstruction within 3 months.
✕. The urine protein ≥ ++ and 24-hour urine protein level \> 1.0g.
✕. 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.
✕. Uncontrolled heart clinical symptoms or diseases, such as :(1) NYHA 2 or more heart failure, (2) Unstable angina pectoris, (3) myocardial infarction within 1 year, (4) Ventricular arrhythmias requiring intervention, (5) QTc\>470ms.