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Compares treatment options for Ovarian Cancer
Official title Niraparib vs Niraparib Plus Bevacizumab in Patients With Platinum/Taxane-based Chemotherapy in Advanced Ovarian Cancer
ClinicalTrials.gov ID: NCT05009082
What this study is testing
What is Carboplatin?
Carboplatin is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for ovarian cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is an international, multicenter, randomized, open, Phase III trial to evaluate the efficacy and safety of carboplatin/paclitaxel/bevacizumab followed by bevacizumab and niraparib compared to carboplatin/paclitaxel followed by niraparib in patients with newly diagnosed advanced ovarian cancer.
- Phase 3: a large, late-stage study
- Time commitment: about 1 year
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- Signed written informed consent obtained prior to initiation of any study-specific procedures and treatment as confirmation of the patient's...
- Female patients ≥ 18 years with histologically confirmed primary advanced invasive high grade non-mucinous, non-clear cell epithelial ovarian cancer...
- All patients must have had either upfront primary debulking surgery OR plan to undergo chemotherapy with interval debulking surgery.
- Patients must have available tumor samples to be sent to central laboratory as formalin-fixed, paraffin-embedded (FFPE) sample for determination of...
- Patients must be able to commence systemic therapy within 8 weeks of cytoreductive surgery.
You likely can't join if
- Non-epithelial tumor origin of the ovary.
- Ovarian tumors of low malignant potential (e.g. borderline tumors) and low grade tumors.
- Planned intraperitoneal cytotoxic chemotherapy.
- Malignancies other than ovarian cancer within 5 years prior to randomization, with the exception of those with a negligible risk of metastasis or...
- Prior systemic treatment for ovarian cancer.
- Prior treatment with Poly adenosine diphosphate ribose polymerase (PARP) inhibitor.
See the full eligibility criteria
Who can join
- Signed written informed consent obtained prior to initiation of any study-specific procedures and treatment as confirmation of the patient's awareness and willingness to comply with the clinical trial requirements.
- Female patients ≥ 18 years with histologically confirmed primary advanced invasive high grade non-mucinous, non-clear cell epithelial ovarian cancer, peritoneal cancer, or fallopian tube cancer FIGO III/IV (except FIGO...
- All patients must have had either upfront primary debulking surgery OR plan to undergo chemotherapy with interval debulking surgery.
- Patients must have available tumor samples to be sent to central laboratory as formalin-fixed, paraffin-embedded (FFPE) sample for determination of BRCA status prior to randomization for stratification.
- Patients must be able to commence systemic therapy within 8 weeks of cytoreductive surgery.
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1.
- Estimated life expectancy \> 3 months.
- Adequate bone marrow function (within 28 days prior to day 1, cycle 1 and within 3 days prior to day 1, cycle 2)
- Absolute Neutrophil Count (ANC) ≥ 1.5 x 10\^9/L
- Platelets (PLT) ≥ 100 x 10\^9/L
- Hemoglobin (Hb) ≥ 9 g/dL (can be post-transfusion)
- Adequate coagulation parameters (within 28 days prior to day 1, cycle 1 and within 7 days prior to day 1, cycle 2)
- Patients not receiving anticoagulant medication who have an International Normalized Ratio (INR) ≤ 1.5 and an Activated ProThrombin Time (aPTT) ≤ 1.5 x institutional upper limit of normal (ULN).
- The use of full-dose oral or parenteral anticoagulants is permitted as long as the INR or aPTT is within therapeutic limits (according to institution medical standard) and the patient has been on a stable dose of...
- Adequate liver and kidney function (within 28 days prior to day 1, cycle 1 and within 3 days prior to day 1, cycle 2)
- Total bilirubin ≤ 1.5 x ULN (≤ 2.0 x ULN in patients with known Gilbert's syndrome) OR direct bilirubin ≤ 1.0 x 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 case...
- Urine dipstick for proteinuria \< 2+. If urine dipstick is ≥ 2+, 24 hour urine must demonstrate ≤ 1 g of protein in 24 hours.
- Serum creatinine ≤ 1.5 x ULN or calculated creatinine clearance ≥ 30 mL/min (see Appendix 2).
- Patients must have normal blood pressure (BP) or adequately treated and controlled BP, with a systolic BP of ≤ 140 mmHg and diastolic BP of ≤ 90 mmHg for eligibility. Patients must have a BP of ≤ 140/90 mmHg taken in...
- Negative urine or serum pregnancy test within 7 days prior to day 1, cycle 1 in women of childbearing potential (WOCBP), confirmed prior to treatment on day 1.
- For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use a highly effective contraceptive method with a failure rate of \< 1% per year during the treatment period...
- Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other clinical trial procedures, that include the completion of patient-reported outcomes questionnaires.
What rules you out
- Non-epithelial tumor origin of the ovary.
- Ovarian tumors of low malignant potential (e.g. borderline tumors) and low grade tumors.
- Planned intraperitoneal cytotoxic chemotherapy.
- Malignancies other than ovarian cancer within 5 years prior to randomization, with the exception of those with a negligible risk of metastasis or death (e.g., 5-year OS rate \> 90%) and treated with expected curative...
- Prior systemic treatment for ovarian cancer.
- Prior treatment with Poly adenosine diphosphate ribose polymerase (PARP) inhibitor.
- Administration of other simultaneous chemotherapy drugs, any other anticancer therapy or anti-neoplastic hormonal therapy, or simultaneous radiotherapy during the trial treatment period (hormonal replacement therapy is...
- Prior randomization in this trial.
- Major surgery within 1 week of starting study treatment or patient who has not completely recovered from the effects of any major surgery. Core biopsy or other minor surgical procedure within 7 days prior to day 1...
- History or clinical suspicion of brain metastases or spinal cord compression. CT/MRI of the brain is mandatory (within 4 weeks prior to day 1, cycle 1) in case of suspected brain metastases. Spinal MRI is mandatory...
- Significant traumatic injury during 4 weeks preceding the potential first dose of bevacizumab.
- Previous Cerebro-Vascular Accident (CVA), Transient Ischemic Attack (TIA) or Sub-Arachnoids Hemorrhage (SAH) within 6 months prior to day 1, cycle 1.
- History or evidence of thrombotic or hemorrhagic disorders within 3 months prior to day 1, cycle 1.
- History or evidence upon neurological examination of central nervous system (CNS) disease, unless adequately treated with standard medical therapy e.g. uncontrolled seizures.
- Pregnant or lactating women.
- Treatment with any other investigational agent, or participation in another clinical trial testing a drug within 4 weeks or 5 times the half-life of the drug, whichever is longer, prior to day 1, cycle 1 or...
- Known hypersensitivity to bevacizumab and its excipients, Chinese hamster ovary cell products or other recombinant human or humanized antibodies. Known hypersensitivity to niraparib, paclitaxel and carboplatin and its...
- Non-healing wound, active ulcer or bone fracture. Patients with granulating incisions healing by secondary intention with no severe evidence of facial dehiscence or infection are eligible; regular wound examination will...
- Clinically significant cardiovascular disease, including
- Myocardial infarction or unstable angina within 6 months of day 1, cycle 1
- New York Heart Association (NYHA) Grade 2 Congestive Heart Failure (CHF),
- Poorly controlled cardiac arrhythmia despite medication (patients with rate-controlled atrial fibrillation are eligible)
- Grade ≥ 3 peripheral vascular disease (i.e. symptomatic and interfering with activity of daily living (ADL) requiring repair or revision)
- Significant vascular disease including aortic aneurysm requiring surgical repair
- Pre-existing sensory or motor neuropathy ≥ Grade 2.
- (Intentionally left blank)
- Patients with a history of or current Nephrotic syndrome.
- Persistent cancer-related bowel obstruction (including subocclusive disease). Patients with a known history of ileus, who have been successfully treated and who are free of symptoms, may be eligible after consultation...
- History of abdominal fistula or tracheoesophageal fistula or gastrointestinal perforation or active gastrointestinal bleeding or anastomotic insufficiency within 6 months of day 1, cycle 1.
- Patients unable to swallow orally administered medication and patients with gastrointestinal disorders likely to interfere with absorption of niraparib.
- Evidence of any other disease, metabolic dysfunction, physical examination finding or laboratory finding giving reasonable suspicion of a disease or condition that contra-indicates the use of an investigational drug or...
- Any known history or current diagnosis of myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML).
- Previous allogeneic bone marrow transplant or previous solid organ transplantation.
- Current or recent (within 10 days prior to day 1, cycle 1) chronic use of aspirin \> 325 mg/day. Patients treated with other inhibitors of platelet aggregation such as clopidogrel, prasugrel, ticlopidine, tirofibane or...
- Patients considered a poor medical risk due to a serious, uncontrolled medical disorder, non-malignant systemic disease or active, uncontrolled infection. This includes also any psychiatric disorder that prohibits...
- Patient has known active hepatitis B or hepatitis C.
- Patient has a history of Posterior Reversible Encephalopathy Syndrome (PRES).
- Patients with chronic inflammatory bowel disease and active treatment for disease control.
The study team makes the final eligibility decision.
Where it's taking place
- Amberg, Germany
- Augsburg, Germany
- Bad Homburg, Germany
- Berlin, Germany
- Bielefeld, Germany
- Brandenburg an der Havel, Germany
- Bremen, Germany
- Chemnitz, Germany
- Cologne, Germany
- Dortmund, Germany
- Dresden, Germany
- Düsseldorf, Germany
- Essen, Germany
- Esslingen am Neckar, Germany
- Frankfurt, Germany
- Frankfurt am Main, Germany
- Giessen, Germany
- Gütersloh, Germany
- Halle, Germany
- Hamburg, Germany
+ 39 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 1 year per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Amberg, Germany; Augsburg, Germany; Bad Homburg, Germany; Berlin, Germany; Bielefeld, Germany; Brandenburg an der Havel, Germany and 53 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.