NCT06964165终止2 期
Cohort C: Open-label Phase 2, Randomized, Controlled Multicenter Study Comparing Niraparib Versus Platinum-Taxane Doublet Chemotherapy as Neoadjuvant Treatment in Participants With Homologous Recombination-Deficient Stage III/IV Ovarian Cancer
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- Tesaro, Inc.
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Pre-Interval Debulking Surgery (IDS) Unconfirmed Overall Response Rate (ORR)
研究概览
简要总结
The goal of the study is to learn whether Niraparib or Platinum-Taxane Doublet chemotherapy is better in treating participants with Homologous Recombination Deficient (HRd) Stage III/IV Ovarian Cancer (OC). This study is a sub-study of the Master protocol -OPAL (NCT03574779)
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
- 否
入选标准
- •Participant has newly diagnosed Stage III or IV ovarian, fallopian tube, or primary peritoneal cancer according to the International Federation of Gynecology and Obstetrics staging criteria.
- •Participants must provide sufficient tumor tissue at Prescreening and agree to undergo a central HRD tumor testing using a fully validated assay. The participants must be HRd as per central HRD tumor testing result for eligibility.
- •Participants with a documented germline breast cancer susceptibility gene (BRCA) 1/2 deleterious or suspected deleterious mutations by Sponsor's permitted test (e.g., BRACAnalysis CDx) may be allowed to enroll prior to receiving the central test results, provided all inclusion criteria are met. However, tumor sample submitted by these participants will still be required for central HRD confirmation. The list of Sponsor's permitted tests will be provided by the Sponsor.
- •All participants must agree to provide tumor tissue collected from IDS.
- •Participant must provide 2 formalin-fixed paraffin-embedded tissue blocks (or slides if blocks are not available) with sufficient tumor content (as confirmed by the Sponsor's designated central and/or testing laboratory) for central HRD testing at Prescreening and for exploratory biomarker testing at Prescreening or Screening. If sufficient tumor tissue is provided at Prescreening, participants do not need to provide additional tissue at Screening.
- •Participant must have completed 1 run-in cycle of carboplatin-paclitaxel and not experienced disease progression after this treatment. Completion is defined as receiving ≥50% of the prescribed dose of therapy within 5 weeks.
- •Participant must not have known contraindication or uncontrolled hypersensitivity to carboplatin and paclitaxel and their excipients and no known pre-existing conditions that would preclude treatment with these agents.
- •Participant must not have known contraindication or uncontrolled hypersensitivity to niraparib and its excipients.
- •Participant must not have symptomatic ascites or pleural effusions as defined by the following criterion: presence of fluid in the abdominal or pleural cavities requiring removal within 1 week prior to signing the informed consent.
- •Participant must agree to complete Patient-reported outcome (PRO) and work productivity questionnaires throughout the study.
排除标准
- •Participant has low-grade or Grade 1 epithelial Ovarian Cancer (OC) or mucinous, germ cell, transitional cell, carcinosarcoma, or undifferentiated tumor.
- •Participant has contraindications to surgery.
- •Participant has a bowel obstruction by clinical symptoms or Computed tomography (CT) scan, subocclusive mesenteric disease, abdominal or gastrointestinal fistula, gastrointestinal perforation, or intra-abdominal abscess.
- •Participant has any known history or current diagnosis of Myelodysplastic Syndrome (MDS) or Acute Myeloid Leukemia (AML).
- •Participant is at increased bleeding risk due to concurrent conditions (e.g., major injuries or major surgery within the past 28 days prior to the start of study treatment and/or history of hemorrhagic stroke, transient ischemic attack, subarachnoid hemorrhage, or clinically significant hemorrhage within the past 3 months).
- •Participant is immunocompromised. Participants with splenectomy are allowed. Participants with known Human immunodeficiency virus (HIV) are allowed if they meet all of the following criteria:
- •Cluster of differentiation 4-positive T cell count ≥350/μL and viral load <400 copies/mL
- •No history of Acquired immunodeficiency syndrome (AIDS)-defining opportunistic infections within 12 months prior to enrollment
- •No history of HIV-associated malignancy for the past 5 years
- •Concurrent antiretroviral therapy as per the most current National Institutes of Health Guidelines for the Use of Antiretroviral Agents in Adults and Adolescents Living with HIV started >4 weeks prior to study enrollment
- •Participant received prior treatment for high-grade non-mucinous epithelial ovarian, fallopian tube, or peritoneal cancer (e.g., prior surgery, immunotherapy, anticancer therapy [with the exception of 1 run-in cycle of carboplatin-paclitaxel], or radiation therapy).
- •Participant has an active autoimmune disease that has required systemic treatment in the past 2 years. Replacement therapy is not considered a form of systemic therapy (e.g., thyroid hormone or insulin).
- •Participant is unable to swallow orally administered medication or has a gastrointestinal disorder likely to interfere with absorption of the study medication.
- •Participant received whole blood transfusions in the 2 weeks prior to entry to the study (packed red blood cells and platelet transfusions are acceptable outside of 2 weeks prior to treatment).
研究组 & 干预措施
Cohort C (Niraparib)
Experimental
干预措施: Niraparib (Drug)
Cohort C (Carboplatin + Paclitaxel)
Experimental
干预措施: Carboplatin (Drug)
Cohort C (Carboplatin + Paclitaxel)
Experimental
干预措施: Paclitaxel (Drug)
结局指标
主要结局
Pre-Interval Debulking Surgery (IDS) Unconfirmed Overall Response Rate (ORR)
时间窗: Up to approximately 102 weeks
Pre-IDS unconfirmed ORR is defined as the percentage of participants with unconfirmed complete or partial response on study treatment pre-IDS as assessed per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by the Investigator. Complete Response (CR) is defined as disappearance of all target and non target lesions and any pathological lymph nodes must be \<10 millimeter (mm) in the short axis. Partial Response (PR) is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the baseline sum of the diameters
次要结局
- Number of Participants With Cancer Antigen (CA)-125 Progression by Gynecological Cancer InterGroup (GCIG) CA-125 Response Criteria(At week 24)
- Progression Free Survival (PFS)(Up to approximately 154 weeks)
- Overall Survival (OS)(Up to approximately 154 weeks)
- Time to First Subsequent Treatment (TFST)(Up to approximately 154 weeks)
- Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)(Baseline (Predose), Day 8 and 15 of Cycle 1; Day 1, 8 and 15 of Cycle 2 and Cycle 3; Pre-IDS Evaluation, and End of Treatment (Up to approximately 154 weeks).)
- Number of Participants With Overall Side Effect Bother as Measured by Functional Assessment of Cancer Therapy - Item FACT-GP5(Baseline (Predose), Day 8 and 15 of Cycle 1; Day 1, 8, and 15 of Cycle 2 and Cycle 3; Pre-IDS Evaluation, and End of Treatment (Up to approximately 154 weeks))
- Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Item Library 136 (EORTC IL136) Questionnaire(Baseline (Predose), Day 1 of Cycle 2 and Cycle 3; Pre-IDS Evaluation, and End of Treatment (Up to approximately 154 weeks).)
- Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Item Library 137 (EORTC IL137) Questionnaire(Baseline (Predose), Day 1 of Cycle 2 and Cycle 3; Pre-IDS Evaluation, and End of Treatment (Up to approximately 154 weeks).)
- Number of Participants With Treatment Emergent (TE) Non-serious Adverse Events (Non-SAEs), Treatment Emergent Serious Adverse Events (TESAEs) and Adverse Events of Treatment Emergent (TE) Special Interest (AESIs) by Severity(Up to approximately 154 weeks)
- Number of Participants With Dose Modification Due to TEAEs(Up to approximately 154 weeks)
研究者
研究点 (1)
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