Ovarian CancerPhase 2NCT06063070
First-line Maintenance Treatment With Fluzoparib Plus Bevacizumab in Advanced BRCA Wild Type Ovarian Cancer
A Phase 2 study testing Fluzoparib Capsules and Bevacizumab in people with Ovarian Cancer and High Grade Serous Adenocarcinoma of Ovary, run by Sun Yat-sen University at 1 site in China.
Trial summary
This is an open-label, multi-center Phase II study of fluzoparib combined with bevacizumab for maintenance therapy after first-line platinum-containing chemotherapy in patients with BRCA wild-type advanced ovarian cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Cancer, High Grade Serous Adenocarcinoma of Ovary, High Grade Endometrioid Ovarian Cancer
- What is being tested?
- Fluzoparib Capsules and Bevacizumab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteChina
- Study dates
- 18 Oct 2023to 30 Oct 2027
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed informed consent and ability to comply with treatment and follow-up.
- Age ≥ 18 years (Calculated on the date the informed consent was signed).
- Pathologically confirmed high-grade serous (or medium-low differentiation) or high grade endometrioid (≥ grade II) ovarian cancer, primary peritoneal cancer and/or fallopian-tube cancer:
- Mixed tumors: high-grade serous or high grade endometrioid (≥ grade II) component must be >50%.
- Patients with newly diagnosed, histologically confirmed, advanced (FIGO stage III or IV of the 2018 FIGO classification) ovarian, fallopian tube, or primary peritoneal cancer; and underwent tumor reduction surgery.
- Patients must have received prior to enrollment a minimum of 6 cycles and a maximum of 9 cycles of first line platinum-taxane chemotherapy. However, if platinum-based therapy must be discontinued early as a result of intolerable toxicity, patients must have received a minimum of 4 cycles of the platinum regimen:
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- -Preoperative neoadjuvant chemotherapy and postoperative chemotherapy counted as 1 chemotherapy treatment regimen.
- Patients must be prior to enrollment in complete response (CR) or partial response (PR) from their first line treatment, and use of the trial drug at least 3 weeks and no more than 9 weeks after their last dose of chemotherapy.
- At least 4 cycles of the platinum regimen treatment were completed.
- During or after platinum-containing chemotherapy, concurrent use of other investigational drugs and treatment other than endocrine therapy drugs are not permitted.
- Bevacizumab in combination with the first line platinum-taxane chemotherapy was allowed.
- At the end of the last platinum-containing regimen, the radiographic evaluation of the efficacy was CR or PR, CA125 was reduced to within the upper limit of normal (ULN) or ≥90% lower than pre-treatment levels during treatment, and CA125 was maintained at <1x ULN or has not >10% higher than previously observed for 7 days before the first trial of drug administration.
- If there is no evaluable lesion prior to chemotherapy, CA125 must remit to <Upper Limit of Normal (ULN) during treatment and CA125 should be maintained at <1x ULN for 7 days prior to the first trial dose.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
- Germline BRCA1/2 wild-type.
- Patients must have normal organ and bone marrow function (use of any blood components and cell growth factors within 14d prior to the first dose is not permitted):
- Absolute neutrophil count (ANC) ≥ 1.5 x 109/L;
- Platelets count ≥ 100 x 109/L;
- Hemoglobin ≥ 9 g/dL;
- Serum albumin ≥ 3 g/dL;
- Bilirubin ≤ 1.5x ULN;
- Aspartate aminotransferase /Serum Glutamic Oxaloacetic Transaminase (ASAT/SGOT)) and Alanine aminotransferase /Serum Glutamic Pyruvate Transaminase (ALAT/SGPT)) ≤ 2.5 x ULN, unless liver metastases are present in which case they must be ≤ 5 x ULN;
- Serum creatinine ≤ 1.5x ULN;
- Postmenopausal or evidence of non-childbearing status for women of childbearing potential prior to the first dose of study treatment.
Who cannot join
- Previous (within 5 years) or concurrent with other uncured malignant tumors, except for cured skin basal cell carcinoma, cervical carcinoma in situ and breast cancer with no recurrence >3 years after radical surgery;
- Patients with untreated central nervous system metastases:
- -Patients with prior treatment (radiotherapy or surgery) for systemic, radical brain or meningeal metastases may be enrolled if imaging confirms that stabilization has been maintained for at least 1 month and systemic hormone therapy (dose >10mg/day prednisone or other equivocal hormone) has been discontinued for more than 2 weeks and who have no clinical evidence can be included;
- Any previous treatment with PARP inhibitor, including, olaparib, niraparib, rucaparib, pamiparib, and fluzoparib;
- Inability to swallow tablets properly or gastrointestinal function, may interfere with drug absorption, according to the investigator.
- Recent (within 3 months) occurrence of intestinal obstruction, gastrointestinal perforation;
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- Patients with clinically symptomatic carcinomatous ascites or pleural effusion who need puncture or drainage or who have received drainage of ascites or pleural effusion within 2 months prior to the first trial of drug administration.
- Patients with clinically significant cardiovascular disease that are not well controlled, such as (1) New York Heart Association (NYHA) ≥ grade 2 congestive heart failure (CHF) (2) unstable angina pectoris (3) myocardial infarction within 1 year (4) clinically significant supraventricular or ventricular arrhythmia requiring treatment or intervention (5) QTc > 470ms;
- Patients with abnormal coagulation (INR > 1.5 or prothrombin time (PT) > ULN + 4 seconds), bleeding tendency, or who are receiving thrombolytic or anticoagulant therapy are permitted to receive low-dose low molecular heparin or oral aspirin for prophylactic anticoagulation during the trial;
- Patients who have experienced clinically significant bleeding symptoms or have a definite bleeding tendency within 3 months prior to the first dose, such as peptic bleeding, bleeding gastric ulcer, or suffering from vasculitis, etc., may be retested if the fecal occult blood is positive at the baseline period, and if it is still positive after the retesting, combined with the clinical judgment, and if necessary, gastroscopy will be carried out;
- Accompanied by active ulcers, unhealed wounds or with fractures;
- Patients who suffering from hypertension which cannot be well controlled by antihypertensive medication (systolic blood pressure ≥ 150mmHg or diastolic blood pressure ≥ 90mmHg);
- Any bleeding event with a severity rating of 2 or more on the CTCAE 5.0 within 4 weeks prior to the first dose;
- Patients has an active infection or an unexplained fever >38.5 degrees during the screening period, prior to the first dose;
- Patients who has a congenital or acquired immune deficiency (e.g., HIV-infected), or active hepatitis (Hepatitis B reference: HBsAg-positive, HBV DNA ≥500 IU/ml; Hepatitis C reference: HCV antibody-positive, HCV viral copy number > upper limit of normal);
- Prior history of radiotherapy, chemotherapy, hormonal therapy, or molecularly targeted therapy less than 4 weeks after completion of therapy (last dose) and prior to study drug administration (less than 5 drug half-lives for oral molecularly targeted agents); prior treatment-induced adverse events (other than alopecia) have not recovered to ≤ 1 degree (CTCAE 5.0);
- Arterial/venous thrombotic events, such as cerebrovascular accidents (including temporary ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis, and pulmonary embolism, occurred within 6 months prior to the first dose of medication.
- Patients with an inherited or acquired history of bleeding or coagulation disorders (e.g. hemophiliacs, coagulation disorders, thrombocytopenia, etc.). There were clinically significant bleeding symptoms or definite bleeding tendency, such as gastrointestinal bleeding, bleeding gastric ulcer, etc., within 3 months prior to the first dose;
- Patients has received other systemic antitumor therapy during the study period;
- In the investigator's judgment, patients have other factors that may lead to the forced termination of the study, such as other serious illnesses (including psychiatric illnesses) that require comorbid treatment, serious laboratory test abnormalities, accompanied by family or social factors, which will affect the subject's safety, or the collection of information and samples.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Sun Yat-sen University Cancer Cetntre
Guangzhou, Guangdong, 510060
Chunyan Lan, MD&PhD, +862087343104, lanchy@sysucc.org.cn
About this study
Official title: An Open, Multicenter, Exploratory Clinical Study of Fluzoparib in Combination With Bevacizumab for Maintenance Therapy After First-line Platinum-containing Chemotherapy in BRCA Wild-type Advanced Ovarian Cancer
This is an open-label, multi-center Phase II study of fluzoparib combined with bevacizumab for maintenance therapy after first-line platinum-containing chemotherapy in patients with BRCA wild-type advanced ovarian cancer. The primary objective is to evaluate median progression free survival of fluzoparib plus bevacizumab.
- Conditions
- Ovarian Cancer, High Grade Serous Adenocarcinoma of Ovary, High Grade Endometrioid Ovarian Cancer, Primary Peritoneal Cancer, Fallopian-tube Cancer
- Being tested
- Fluzoparib Capsules, Bevacizumab
- Keywords
- ovarian cancer, PARP inhibitors, Flzuoparib, Antiangiogenic agents, Bevacizumab, BRCA wild-type
- Medical subject headings
- Ovarian Neoplasms, Fallopian Tube Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluzoparib CapsulesDrug
Also called Poly (ADP-ribose) polymerase (PARP) inhibitor
oral
BevacizumabDrug
Also called Antiangiogenic agents
Injectable solution
| Study group | Role | What they receive |
|---|---|---|
| Fluzoparib + Bevacizumab | Experimental | Fluzoparib capsule: oral administration, 3 capsules/dose (150 mg/ dose), twice a day, in the morning and evening, before/after meals can be taken orally, it is recommended to take orally within 0.5h after breakfast and dinner, continuous administration. Every 3 weeks is a treatment cycle.
Bevacizumab injection: intravenous, 15 mg/kg, every 3 weeks for a treatment cycle until disease progression or intolerable toxicity, up to a total of 15 months. Receives: Drug: Fluzoparib Capsules; Drug: Bevacizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free Survival (PFS)
Time from the date of first study treatment administration to the date of first documented tumor progression or death due to any cause, whichever occurs first.
Measured: from the first drug administration up to 2 years
Secondary outcomes (7)
Overall survival (OS)
Time from the date of first study treatment administration to the date of death due to any cause.
Measured: from the first drug administration up to 5 years
Objective Response Rate (ORR)
ORR is the proportion of patients with best response of complete response (CR) and partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
Measured: from the first drug administration up to 2 years
Time to start of first subsequent therapy or death (TFST)
TFST is defined as the time from the first study administration to the earliest of the date of anti-cancer therapy start date following study treatment discontinuation, or death.
Measured: from the first drug administration up to 5 years
Time to start of second subsequent therapy or death (TSST)
TSST is defined as the time from the first study administration to the earliest of the date of second subsequent anti-cancer therapy start date following study treatment discontinuation, or death.
Measured: from the first drug administration up to 5 years
Time to progression(TTP）by RECIST or CA-125
Time to progression by RECIST v. 1.1 or CA-125 or death is defined as the time from the first study administration to the date of RECIST or CA-125 progression or death by any cause, whichever occurs first.
Measured: from the first drug administration up to 5 years
Safety and tolerability
Incidence, nature, and severity of adverse events graded according to the NCI CTCAE v5.0.
Measured: from the first drug administration up to 5 years
Patient Reported Outcomes (PROs)
Determination of changes in PROs with EQ-5D-5L
Measured: from the first drug administration up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2023
- Study start18 Oct 2023 (estimated)
- Primary completion31 Jan 2025 (estimated)
- Study completion30 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Drug: fluzoparib plus Bevacizumab
- Masking
- None (open label)
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xin Huang, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06063070
- Sponsor's protocol ID
- B2023-321-01
- Status last verified
- Sep 2023
- First submitted
- 19 Sep 2023
- Last updated
- 2 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided