A RANDOMIZED, DOUBLE-BLIND, PHASE 3 COMPARISON OF PLATINUM-BASED THERAPY WITH TSR 042 AND NIRAPARIB VERSUS STANDARD OF CARE PLATINUM-BASED THERAPY AS FIRST LINE TREATMENT OF STAGE III OR IV NONMUCINOUS EPITHELIAL OVARIAN CANCER - FIRST

TESARO, Inc.0 个研究点目标入组 38 人开始时间: 待定最近更新: 2024年9月9日

适应症

试验速览

阶段: 3 期
状态: 招募中
发起方: TESARO, Inc.
入组人数: 38

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional

入排标准

年龄范围: 18 至 99（—）

入选标准

•To be considered eligible to participate in this study, all of the following
•requirements must be met:
•1. Patients must be female, >=18 years of age, able to understand the study
•procedures, and agree to participate in the study by providing written informed
•2. Patients with a histologically confirmed diagnosis of high-grade
•nonmucinous epithelial ovarian (serous, endometrioid, clear cell,
•carcinosarcoma, and mixed pathologies), fallopian tube, or primary peritoneal
•cancer that is Stage III or IV according to the International Federation of
•Gynecology and Obstetrics or tumor, node and metastasis staging criteria [ie,
•American Joint Committee on Cancer].
•3. All patients with Stage IV disease are eligible. This includes those with
•inoperable disease, those who undergo PDS (CC0 or macroscopic disease), or
•those for whom NACT is planned.
•4. Patients with Stage III are eligible if they meet one or more of the
•following criteria:
•a. Stage IIIC patients with CC0 resection if they meet the following criteria:
•aggregate >=5 cm extra-pelvic disease during PDS as assessed by the Investigator
•b. All patients with inoperable Stage III disease
•c. All Stage III patients with macroscopic residual tumor (per Investigator
•judgment) following PDS
•d. All Stage III patients for whom NACT is planned.
•5. Patient must provide a blood sample for ctDNA HRR testing at Pre-Screening
•or Screening.
•6. Patient must provide sufficient tumor tissue sample (a minimum of 1 FFPE
•block or slide at Pre-Screening or Screening for PD-L1, homologous
•recombination deficiency HRD testing.
•7. Patients of childbearing potential must have a negative serum or urine
•pregnancy test (beta human chorionic gonadotropin) within 3 days prior to
•receiving the first dose of study treatment.
•8. Patients must be postmenopausal, free from menses for >1 year, surgically
•sterilized, or willing to use highly effective contraception to prevent
•pregnancy or must agree to abstain from activities that could result in
•pregnancy throughout the study, starting with enrollment through 180 days after
•the last dose of study treatment.
•9. Patients must have adequate organ function, defined as follows (Note: CBC
•test should be obtained without transfusion or receipt of stimulating factors
•within 2 weeks before obtaining Screening blood sample):
•a. Absolute neutrophil count >=1,500/µL
•b. Platelet count >=100,000/µL
•c. Hemoglobin >=9 g/dL
•d. Serum creatinine <=1.5 × upper limit of normal (ULN) or calculated creatinine
•clearance >=60 mL/min using the Cockcroft-Gault equation
•e. Total bilirubin <=1.5 × ULN or direct bilirubin <=1.5 × ULN
•f. Aspartate aminotransferase and alanine aminotransferase (ALT) <=2.5 × ULN
•unless liver metastases are present, in which case they must be <=5 × ULN
•10. Patients must have an ECOG score of 0 or 1.
•11. Patients must have normal blood pressure (BP) or adequately treated and
•controlled hypertension (systolic BP <=140 mmHg and/or diastolic BP <=90 mmHg).
•12. Patients must agree to complete HRQoL questionnaires throughout the study.
•13. Patients must be able to take oral medication.

排除标准

•Patients will not be eligible for study entry if any of the following criteria
•1. Patient has mucinous, germ cell, transitional cell, or undifferentiated
•2. Patient has low grade or Grade 1 epithelial ovarian cancer.
•3. Stage III patient with R0 resection after PDS (ie, no macroscopic residual
•disease, unless inclusion criterion #4a is met).
•4. Patient has not adequately recovered from prior major surgery.
•5. Patient has a known condition, therapy, or laboratory abnormality that might
•confound the study results or interfere with the patient*s participation for
•the full duration of the study treatment in the opinion of the Investigator.
•6. Patient is pregnant or is expecting to conceive children while receiving
•study drug or for up to 180 days after the last dose of study drug. Patient is
•breastfeeding or is expecting to breastfeed within 30 days of receiving the
•final dose of study drug (women should not breastfeed or store breastmilk for
•use, during niraparib treatment and for 30 days after receiving the final dose
•of study treatment).
•7. Patient has known active central nervous system metastases, carcinomatous
•meningitis, or both.
•8. Patient has clinically significant cardiovascular disease (eg, significant
•cardiac conduction abnormalities, uncontrolled hypertension, myocardial
•infarction, uncontrolled cardiac arrhythmia or unstable angina <6 months to
•enrollment, New York Heart Association Grade 2 or greater congestive heart
•failure, serious cardiac arrhythmia requiring medication, Grade 2 or greater
•peripheral vascular disease, and history of cerebrovascular accident within 6
•9. Patient has a bowel obstruction by clinical symptoms or CT scan,
•subocclusive mesenteric disease, abdominal or gastrointestinal fistula,
•gastrointestinal perforation, or intra abdominal abscess.
•10. Patient initiating bevacizumab as SOC has proteinuria as demonstrated by
•urine protein:creatinine ratio >=1.0 at Screening or urine dipstick for
•proteinuria >=2 (patients discovered to have >=2 proteinuria on dipstick at
•baseline should undergo a 24 hour urine collection and must demonstrate <2 g of
•protein in 24 hours to be eligible).
•11. Patient has any known history or current diagnosis of MDS or AML.
•12. Patient has been diagnosed and/or treated with any therapy for invasive
•cancer <5 years from study enrollment, completed adjuvant chemotherapy and/or
•targeted therapy (eg, trastuzumab) less than 3 years from enrollment, or
•completed adjuvant hormonal therapy less than 4 weeks from enrollment. Patients
•with definitively treated noninvasive malignancies such as cervical carcinoma
•in situ, ductal carcinoma in situ, Grade 1 or 2, Stage I endometrial cancer, or
•non -melanomatous skin cancer are allowed.
•13. Patient is at increased bleeding risk due to concurrent conditions (eg,
•major injuries or major surgery within the past 28 days prior to start of study
•treatment and/or history of hemorrhagic stroke, transient ischemic attack,
•subarachnoid hemorrhage, or clinically significant hemorrhage within the past 3
•14. Patient is immunocompromised. Patients with splenectomy are allowed.
•Patients with known human immunodeficiency virus (HIV) are allowed if they meet
•all of the following criteria:
•a. Cluster of differentiation 4 >=350/µL and viral load

研究者

发起方

TESARO, Inc.

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