EUCTR2020-000146-33-DE进行中（未招募）1 期
Randomized phase III trial on NIraparib-dostarlimab vs physician’s choice CHEmotherapy in recurrent, ovarian, fallopian tube or primary peritoneal cancer patients not candidate for platinum retreatment: NItCHE trial (MITO 33) - NItCHE
FONDAZIONE POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI IRCCS UNIVERSITA' CATTOLICA DEL SACRO CUORE0 个研究点目标入组 427 人开始时间: 2020年11月18日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 427
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Female
入选标准
- •1. Participant must have recurrent ovarian, Fallopian tube or primary peritoneal cancer not candidate for platinum retreatment;
- •2. Participant must have an Eastern Cooperative Oncology Group (ECOG) performance status of <= 1
- •3. Participants must have measurable disease or evaluable based on RECIST 1.1 (patients with only CA 125 increase without evidence of disease are not included).
- •4. Participant must be >= 18 years of age
- •5. Participant must have adequate organ 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 >= 60mL/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
- •International normalized ratio (INR) or prothrombin time (PT) <=1.5× ULN unless patient is receiving anticoagulant therapy as long as PT or partial thromboplastin (PTT) is within therapeutic range of intended use of anticoagulants. Activated partial thromboplastin time (aPTT) <=1.5× ULN unless patient is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants
- •6. Pre-existing hypertension should be adequately controlled before starting niraparib treatment.
- •7. Participant must agree to not donate blood during the study or for 90 days after the last dose of study treatment.
- •8. Participants must agree to provide tissue from a newly obtained core or excisional biopsy of a tumor lesion. Newly-obtained is defined as a specimen obtained up to 6 weeks (42 days) prior to initiation of treatment on Day 1. Subjects for whom newly-obtained samples cannot be provided (e.g. inaccessible or subject safety concern) may submit an archived specimen.
- •9. Female participant has a negative urine or serum pregnancy test within 7 days prior to taking study treatment if of 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 is of nonchildbearing potential. Nonchildbearing potential is defined as follows (by other than medical reasons):
- •>=45 years of age and has not had menses for >1 year nd has a high follicle-stimulating hormone (FSH) level in the postmenopausal ranges confirmed by two FSH measurements
- •Patients who have been amenorrhoeic 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 of the actual procedure, 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. Information must be captured appropriately within the site’s source documents. Note: Abstinence is acceptable if this is the established and preferred contraception for the patient.
- •10. Participant must agree to not breastfeed during the study or for 180
排除标准
- •1. Participant must not be simultaneously enrolled in any interventional clinical trial
- •2. Participants have received >2 previous CHT lines
- •3. Participant must not have had major surgery <= 3 weeks prior to initiating protocol therapy and participant must have recovered from any surgical effects.
- •4. Participant must not have 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.
- •5. Participant has had radiation therapy encompassing >20% of the bone marrow within 2 weeks; or any radiation therapy within 1 week prior to Day 1 of protocol therapy.
- •6. Participant has not recovered to Grade 1 or baseline from all toxicities associated with previous therapy.
- •7. Participant must not have a known hypersensitivity to niraparib and Dostarlimab components or excipients and must not have any
- •hypersensitivity to the treatment used as standard of care in the control arm.
- •8. Participant must not show contra indications to other agents (including chemotherapy) used in this study
- •9. Participant must not have received a transfusion (platelets or red blood cells) <= 4 weeks prior to initiating protocol therapy.
- •10. Participant must not have received colony-stimulating factors within 4 weeks prior initiating protocol therapy.
- •11. Participant 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.
- •12. Participant must not have a diagnosis of Sars-CoV-2 infections at the time of screening
- •13. Participant must not have any known history of myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML)
- •14. Participant must not have a serious, uncontrolled medical disorder, nonmalignant systemic disease, or active, uncontrolled infection. Examples include, but are not limited to, 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
- •15. Participant must not have had diagnosis, detection, or treatment of another type of cancer <= 3 years prior to initiating protocol therapy (except basal or squamous cell carcinoma of the skin and cervical cancer that has been definitively treated)
- •16. Participant must not have known, symptomatic brain or leptomeningeal metastases
- •17. Patient experienced >= Grade 3 immune-related AE with prior immunotherapy, with the exception of non-clinically significant lab abnormalities.
- •18. Participant has a diagnosis of immunodeficiency or has an active autoimmune disease that has required systemic treatment in the past 2 years (ie, with use of disease-modifying agents, corticosteroids, or immunosuppressive drugs) or has received systemic steroid therapy at a dose > 10 mg/day or any other form of immunosuppressive therapy within 7 days prior to initiating protocol therapy. Local or systemic corticosteroid treatment at a dosage less or equal than 10 mg/day is allowed. Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
- •19. Participant has a known history of human immunodeficiency virus (type 1 or 2 antibodies).
- •20. Participant has known active hepati
研究者
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