NCT05551208RecruitingPhase 2
Fluzoparib Combined With Bevacizumab in PSROC Previously Treated With PARPi
A Prospective, Single-arm, Multicenter Phase Ⅱ Clinical Study of Fluzoparib Combined With Bevacizumab in Platinum-sensitive Recurrent Ovarian Cancer Patients Previously Treated With PARPi
Source: ClinicalTrials.gov · Last updated 22 Sept 2022 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
There are more and more PARPi(PARP inhibitors) resistance for ovarian cancer patients after previous use of PARP inhibitors. Basic studies have found that there is synergistic effect of bevacizumab combined with PARPi. Therefore we designed the study to include 42 ovarian cancer patients who had PARPi for at least half a year and then relapsed (platinum-sensitive, previously 1-3 lines of chemotherapy). After getting complete remission or partial remission with chemotherapy containing platinum and bevacizumab, fluzopanib and bevacizumab were used for maintenance treatment. The progression-free survival, ORR, DCR, DoR, and safety were evaluated based on RECIST V1.1.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 42 (estimated)
- First submitted
- 31 Aug 2022
- Start date
- 15 Aug 2022
- Primary completion date
- 30 Aug 2024
- Lead sponsor
- Chongqing University Cancer Hospital
- Diseases
- Ovarian cancer
- NCT number
- NCT05551208
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 42
- From 15 Aug 2022 to the primary completion date, 30 Aug 2024
- 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
- Had used bevacizumab within 6 months of enrollment
- The patient had Recent intestinal obstruction, gastrointestinal perforation within 3 months, uncontrolled high blood pressure after medication (Systolic blood pressure ≥140mmHg or diastolic blood pressure ≥90mmHg), Moderate to severe cerebrovascular accident (including temporary ischemic attack, cerebral hemorrhage, cerebral infarction), moderate to severe deep vein thrombosis and moderate to severe pulmonary embolism occurred within 6 months before enrollment. Patient with coagulation dysfunction.
Other illness
- Has combined with other malignant tumor which diagnosed within 5 years and/or needed to be treated. The patients had untreated CNS metastases.
- Myocardial infarction, severe arrhythmia and NYHA (New York heart association)≥2 for congestive heart failure
- Activity or uncontrol severe infection
Who the study is looking for
- Ovarian cancer patients with histopathological type: low/high grade serous carcinoma, endometrioid carcinoma,had received platinum-based regimens for at least 1-3 lines after primary cytoreductive surgery.
- The patient had at least one measurable lesion according to the RECIST V1.1 criteria.
- The time from the last cycle of chemotherapy to relapse/progression should be more than 6 months.
- ECOG score 0\~1,age 18\~75 years old
- The serum or urine pregnancy test must be negative within 7 days before enrollment for the women of childbearing age who should agree that contraception must be used during the trial
- CBC Hb≥90g/L, ANC≥1.5×109/L, PLT≥100×109/L,
- Serum ALT≤3×UL, AST≤3×ULN#Serum creatinine≤1.5×ULN#
Age in the registry: 18 years to 75 years · 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 |
|---|---|---|---|
| Chongqing Cancer Hospital Coordinator of this site? Confirm its status | Chongqing | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.