A Study to Evaluate Efficacy and Safety of Pazopanib Monotherapy in Asian Women Who Have Not Progressed After First-line Chemotherapy for Advanced Ovarian, Fallopian Tube or Primary Peritoneal Carcinoma - An Extension Study to VEG110655
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 145
- 试验地点
- 1
- 主要终点
- Progression-free Survival (PFS)
研究概览
简要总结
This is a study to determine whether therapy with pazopanib is effective and safe in Asian women with epithelial ovarian, fallopian tube or primary peritoneal cancer whose cancer has not progressed on first-line chemotherapy.
详细描述
This study is an extension study to the VEG110655 study. The parent study, VEG110655, was designed to evaluate whether pazopanib 800 mg daily for 52 weeks will prolong progression free survival (PFS) in women diagnosed with ovarian, fallopian tube or primary peritoneal cancer. These women will have obtained stable disease, a complete remission, or a partial remission after debulking surgery and at least five cycles of chemotherapy (taxane/platinum). This extension study will evaluate safety and efficacy outcomes of pazopanib monotherapy and placebo in an Asian population with the same indication as the parent study.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •written informed consent
- •At least 18 years old.
- •Histologically confirmed, International Federation of Gynecology and Obstetrics (FIGO) stage II-IV epithelial ovarian, fallopian tube or primary peritoneal carcinoma that was treated with surgical debulking and at least five cycles of platinum-taxane doublet chemotherapy.
- •Study randomization at least 3 weeks and not more than 12 weeks from the date of the last chemotherapy dose, and all major toxicities from the previous chemotherapy must have resolved.
- •No evidence of disease progression
- •Eastern Cooperative Oncology Group (ECOG) performance status of less than or equal to 2
- •Able to swallow and retain oral medication.
- •Adequate hematologic, hepatic, and renal system function as follows:
- •Hematologic
- •Absolute neutrophil count (ANC) at least 1.5 X 10^9/L
- •Hemoglobin at least 9 g/dL (or 5.59 mmol/L)
- •Platelets at least 100 X 10^9/L
- •Prothrombin time (PT) or international normalized ratio (INR) up to 1.2 X ULN
- •Activated partial thromboplastin time (aPTT) up to 1.2 X ULN Hepatic
- •Total bilirubin up to 1.5 X ULN
- •AST and ALT up to 2.5 X ULN Renal
- •Serum creatinine up to 1.5 mg/dL
- •Or, if greater than 1.5 mg/dL:
- •Calculated creatinine clearance at least 50 mL/min Urine Protein
- •Urine protein is 0, trace, or +1 determined by dipstick urinalysis, or < 1.0 gram determined by 24-hour urine protein analysis.
- •Non-childbearing potential (i.e., physiologically incapable of becoming pregnant) OR childbearing potential, and agrees to use adequate contraception.
排除标准
- •Either (a) bulky disease, or (b) any residual disease which in the opinion of the investigator will need imminent second-line therapy
- •Synchronous primary endometrial carcinoma, or a past history of primary endometrial carcinoma, are excluded unless certain conditions are met.
- •Clinically significant gastrointestinal abnormalities
- •Prolongation of corrected QT interval (QTc) > 480 msecs
- •History of any one or more cardiovascular conditions within the past 6 months prior to randomization
- •Poorly controlled hypertension
- •History of cerebrovascular accident (including transient ischemic attacks), pulmonary embolism or untreated deep venous thrombosis (DVT) within the past 6 months prior to randomization
- •Major surgery (including interval debulking) or trauma within 28 days, or minor surgical procedures within 7 days, prior to randomization, or has any non-healing wound, fracture, or ulcer.
- •Evidence of active bleeding or bleeding diathesis.
- •Hemoptysis within 6 weeks prior to randomization.
- •Endobronchial metastases.
- •Serious and/or unstable pre-existing medical (e.g., uncontrolled infection), psychiatric, or other condition that could interfere with subject's safety, provision of informed consent, or compliance to study procedures.
- •Investigational or anti-VEGF anticancer therapy prior to study randomization.
- •Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to pazopanib.
- •Prior or concurrent invasive malignancies that currently or within the last 5 years show/ed activity of disease (except ovarian, fallopian tube, or peritoneal cancer, or concurrent endometrial cancer FIGO stages IA/B)
研究组 & 干预措施
pazopanib
experimental medication
干预措施: Pazopanib (Drug)
placebo
placebo comparator
干预措施: Placebo comparator (Drug)
结局指标
主要结局
Progression-free Survival (PFS)
时间窗: From randomization until evidence of progressive disease or death, whichever occurred first (average of 15.2 months)
PFS is defined as the time interval between randomization and evidence of progressive disease (PD), as assessed by the investigator using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0, or death, whichever occurred first. A visit-based analysis approach to determine participants' dates of progression was applied in the analysis method. PD is defined as at least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as a reference, the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Participants who were alive and had not progressed at the time of analysis were censored at the date associated with the last visit with adequate assessment.
次要结局
- Overall Survival(From randomization until death due to any cause (average of 29.4 months))
- PFS by Gynaecologic Cancer Intergroup (GCIG) Criteria(From randomization to the earliest date of disease progression per GCIG criteria or death due to any cause (average of 15.2 months))
- Number of Participants With Any Dose Reduction or Any Dose Interruption(From Week 1 until the end of the treatment period (up to Study Week 108))
- Number of Participants With Any Non-serious Adverse Event (AE) and Any Serious Adverse Event (SAE)(From Week 1 until the end of the treatment period (up to Study Week 108))
- Number of Participants With Any On-therapy AE and Any AE Related to Study Treatment(From Week 1 until the end of the treatment period (up to Study Week 108))
- Number of Participants With Any Grade 3 or 4 AE(From Week 1 until the end of the treatment period (up to Study Week 108))
- Number of Participants With the Indicated On-therapy Grade 3-5 AEs(From Week 1 until the end of the treatment period (up to Study Week 108))
- Number of Participants With AEs Leading to Permanent Discontinuation of Study Treatment, Dose Interruption, and Dose Reduction(From Week 1 until the end of the treatment period (up to Study Week 108))
- Number of Participants With Any SAE, Any SAE Related to Study Treatment, and Any Fatal SAE(From Week 1 until the end of the treatment period (up to Study Week 108))
- Number of Participants With the Indicated Worst-case On-therapy Blood Pressure Shifts From Baseline(From Week 1 until the end of the treatment period (up to Study Week 108))
- Number of Participants With the Indicated Worst-case On-therapy Shift From Baseline in Bazett's Corrected QT Interval (QTc)(From Week 1 until the end of the treatment period (up to Study Week 108))
- Number of Participants With the Indicated Worst-case On-therapy Hematology Parameter Grade Shifts From Baseline Grade(From Week 1 until the end of the treatment period (up to Study Week 108))
- Number of Participants With the Indicated Worst-case On-therapy Chemistry Parameter Grade Shifts From Baseline Grade(From Week 1 until the end of the treatment period (up to Study Week 108))
- Number of Participants With the Indicated Worst-case Eastern Cooperative Oncology Group (ECOG) Performance Status Shifts From Baseline Grades of 0, 1, and 2(From Week 1 until the end of the treatment period (up to Study Week 108))