NCT03891576终止2 期
A Multicenter, Open-label Phase II Trial of a New Customized Dosing (RADAR Dosing) of Niraparib As Maintenance Therapy in Platinum Sensitive Ovarian, Fallopian Tube or Primary Peritoneal Recurrent Cancer Patients
Mario Negri Institute for Pharmacological Research12 个研究点 分布在 2 个国家目标入组 83 人开始时间: 2019年11月13日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 83
- 试验地点
- 12
- 主要终点
- Safety: Occurrence of grade ≥3 thrombocytopenia
研究概览
简要总结
This study evaluates whether the adoption of the RADAR dosing strategy could further reduce treatment related toxicities improving the safety profile of niraparib.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •18 years of age or older, female, any race
- •Histologically diagnosed ovarian cancer, fallopian tube cancer or primary peritoneal cancer
- •High grade (or grade 3) serous histology or known to have gBRCAmut
- •Has received at least 2 previous lines of platinum-containing therapy (not necessarily consecutive), and has disease that was considered platinum sensitive following the penultimate platinum line (more than 6-months period between penultimate platinum regimen and progression of disease)
- •Has responded to the last platinum line (PR or CR)
- •No more than 8 weeks have elapsed from completion of the last platinum regimen and the patient is still not progressing after response
- •Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1
- •Adequate bone marrow, kidney and liver function, defined as follows:
- •Absolute neutrophil count ≥ 1,500/µL
- •Platelets ≥ 100,000/µL
- •Hemoglobin ≥ 9 g/dL
- •Serum creatinine ≤ 1.5 x upper limit of normal (ULN) or calculated creatinine clearance ≥ 30 mL/min using the Cockcroft-Gault equation
- •Total bilirubin ≤ 1.5 x ULN (≤2.0 in patients with known Gilberts syndrome) OR direct bilirubin ≤ 1 x ULN
- •Aspartate aminotransferase and alanine aminotransferase ≤ 2.5 x ULN unless liver metastases are present, in which case they must be ≤ 5 x ULN
- •Patient receiving corticosteroids may continue as long as their dose is stable for least 4 weeks prior to initiating protocol therapy.
- •Patient must have a negative urine or serum pregnancy test within 7 days prior to taking study treatment if childbearing potential and agrees to abstain from activities that could result in pregnancy from screening through 180 days after the last dose of study treatment or use adequate barrier methods throughout the study. Non-childbearing potential is defined as follows (by other than medical reasons): ≥45 years of age and has not had menses for >1 year; patients with amenorrhea for <2 years without history of a hysterectomy and oophorectomy must have a follicle stimulating hormone value in the postmenopausal range upon screening evaluation; Post-hysterectomy, post-bilateral oophorectomy, or post-tubal ligation. Documented hysterectomy or oophorectomy must be confirmed with medical records of the actual procedure or confirmed by an ultrasound. Tubal ligation must be confirmed with medical records, otherwise the patient must be willing to use 2 adequate barrier methods throughout the study, starting with the screening visit through 180 days after the last dose of study treatment.
- •Patient must agree to not breastfeed during the study or for 180 days after the last dose of study treatment.
- •Patient must be able to understand the study procedures and agree to participate in the study by providing written informed consent.
- •Patients must have normal blood pressure or adequately treated and controlled hypertension. (i.e. systolic BP ≤ 140 mmHg and diastolic BP ≤ 90 mmHg)
排除标准
- •Patient simultaneously enrolled in any interventional clinical trial
- •Invasive cancer other than ovarian cancer within 2 years (except basal or squamous cell carcinoma of the skin that has been definitely treated)
- •Patient with known, symptomatic brain or leptomeningeal metastases
- •Patient with immunocompromised status
- •Patient with known active hepatic disease
- •Prior treatment with a known PARP inhibitor
- •Patient who has had major surgery ≤ 3 weeks prior to initiating protocol therapy and participant must have recovered from any surgical effects.
- •Patient who has received investigational therapy ≤ 4 weeks, or within a time interval less than at least 5 half-lives of the investigational agent, whichever is shorter, prior initiating protocol therapy.
- •Patient has had radiation therapy encompassing >20% of the bone marrow within 2 weeks prior to day 1 of protocol therapy
- •Patient has had any radiation therapy within 1 week prior to day 1 of protocol therapy.
- •Patient with known hypersensitivity to niraparib components or excipients.
- •Patient has received a transfusion (platelets or red blood cells) ≤ 4 weeks prior to initiating protocol therapy.
- •Patient has received colony stimulating factors (e.g., granulocyte colony-stimulating factor, granulocyte macrophage colony stimulating factor, or recombinant erythropoietin) within 4 weeks prior initiating protocol therapy.
- •Patient has had any known Grade 3 or 4 anemia, neutropenia or thrombocytopenia due to prior chemotherapy that persisted > 4 weeks and was related to the most recent treatment.
- •Patient with any known history of myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML)
- •Patient with a serious, uncontrolled medical disorder. Examples include, but are not limited to, nonmalignant systemic disease, active, uncontrolled infection, uncontrolled ventricular arrhythmia, recent (within 90 days) myocardial infarction, uncontrolled major seizure disorder, unstable spinal cord compression, superior vena cava syndrome, or any psychiatric disorder that prohibits obtaining informed consent
研究组 & 干预措施
Niraparib 200 mg
Experimental
Niraparib will be administered every day as oral at a fixed dose of 200 mg
干预措施: Niraparib (Drug)
Niraparib 300 mg
Active Comparator
Niraparib will be administered every day as oral at a fixed dose of 300 mg
干预措施: Niraparib (Drug)
Niraparib 200mg/300mg
Other
Niraparib will be administered every day as oral at a fixed dose of 200 mg or 300 mg
干预措施: Niraparib (Drug)
结局指标
主要结局
Safety: Occurrence of grade ≥3 thrombocytopenia
时间窗: 3 months
Rate of patients experiencing a grade ≥3 thrombocytopenia during the first three cycles
次要结局
- Compliance(Up to two years after the last patient enrolled)
- Safety: Grade 3-4 toxicities(Up to two years after the last patient enrolled)
- Safety: Number of patients with at least a SAE(Up to two years after the last patient enrolled)
- Safety: Occurrence of grade ≥ 3 thrombocytopenia(6 months)
- Safety: SAE(Up to two years after the last patient enrolled)
- Safety: Number of patients with at least a SADR(Up two years after last patient enrolled)
- Safety: Maximum toxicity grade(Up to two years after the last patient enrolled)
- Efficacy: OS(Up two years after last patient enrolled)
- Safety: Number of patients with at least a SUSAR(Up two years after last patient enrolled)
- Efficacy: PFS-6(6 months)
- Efficacy: PFS(Up two years after last patient enrolled)
- Pharmacokinetic(Up to two years after the last patient enrolled)
研究者
研究点 (12)
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