NCT01238770已完成1 期
A Phase I/II Study of Pazopanib (GW786034) and Cyclophosphamide in Patients With Platinum-resistant Recurrent, Pre-treated Ovarian Cancer
Priv.-Doz. Dr. med. Joachim Rom5 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2010年11月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 5
- 主要终点
- Determination of the optimal doses for pazopanib (phase I)
研究概览
简要总结
The current trial shall clarify the potential of the multitarget antiangiogenic tyrosinkinase inhibitor GW 786034 (pazopanib) in combination with oral cyclophosphamide as salvage treatment in patients with recurrent, pretreated ovarian cancer.
详细描述
This study is a prospective open-label, non-randomized multicenter phase I/II trial in order to determine overall response rate of patients with platinum-resistant or refractory recurrent, pretreated epithelial ovarian cancer.
In order to assure adequate toxicity assessment, a phase-I-trial is proponed. Phase II will be performed with MTD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Written informed consent
- •Female subjects ≥18 years of age
- •Histologically or cytologically confirmed diagnosis of: epithelial ovarian cancer which is platinum resistant or platinum refractory,cancer of the fallopian tube, peritoneal cancer
- •Patients must have failed available standard chemotherapy regimen
- •Prior treatment with at least 2 chemotherapy regimens in advanced tumor setting
- •Performance status ECOG 0 - 2
- •Adequate contraception
- •Adequate organ function
- •Measurable disease according to RECIST criteria.
- •Able to swallow and retain oral medication.
- •Life expectancy of at least 12 weeks.
排除标准
- •Any second malignancy within the last 5 years, with the exception of basal cell or squamous cell skin cancer or in situ carcinoma of the cervix uteri
- •History or clinical evidence of central nervous system (CNS) metastases or leptomeningeal carcinomatosis, except for individuals who have previously-treated CNS metastases, are asymptomatic, and have had no requirement for steroids or anti-seizure medication for 6 months prior to first dose of study drug.
- •Clinically significant gastrointestinal abnormalities which might interfere with oral dosing
- •Any unstable or serious concurrent condition (e.g., active infection requiring systemic therapy).
- •Prolongation of corrected QT interval (QTc) >480 msecs.
- •History of any one or more of the following cardiovascular conditions within the past 6 months:
- •Cardiac angioplasty or stenting
- •Myocardial infarction
- •Unstable angina
- •Symptomatic peripheral vascular disease
- •Coronary artery by-pass graft surgery
- •Class II, III or IV congestive heart failure as defined by the New York Heart Association (NYHA)
- •History of cerebrovascular accident, pulmonary embolism or untreated deep venous thrombosis (DVT) within the past 6 months
- •Macroscopic hematuria
- •Hemoptysis that is clinically relevant within 4 weeks of first dose of study drug
- •Evidence of active bleeding or bleeding diathesis
- •Known endobronchial lesions or involvement of large pulmonary vessels by tumor
- •Prior major surgery or trauma within 14 days prior to first dose of study drug and/or presence of any non-healing wound, fracture, or ulcer.
- •Chemotherapy or radiation therapy within 2 weeks prior to the first dose of study drug.
- •Biological therapy, hormonal therapy or treatment with an investigational agent within 28 days or 5 half-lives
- •Prior antiangiogenic therapy.
- •Is unable or unwilling to discontinue predefined prohibited medications listed in the protocol for 14 days or five half-lives of a drug (whichever is longer) prior to Visit 1 and for the duration of the study
- •Any ongoing toxicity from prior anti-cancer therapy that is > Grade 1 and/or that is progressing in severity.
- •Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to pazopanib
- •Psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol.
- •More than 3 different chemotherapy regimens in advanced tumor setting
- •Uncontrolled hypertension
- •History of ischemic event (stroke, myocardial infarction, unstable angina, TIA, symptomatic peripheral vascular disease)
- •History or clinical evidence of thrombo-embolic event
- •History of haemoptysis, cerebral, or clinically significant gastrointestinal haemorrhage in the past 6 months
- •Active bleeding
- •Signs/Suspicion of intestinal obstruction
研究组 & 干预措施
Cyclophosphamid + Pazopanib
Experimental
Cyclophosphamid + Pazopanib
干预措施: Pazopanib (Drug)
结局指标
主要结局
Determination of the optimal doses for pazopanib (phase I)
时间窗: 42 months
Overall response rate according to RECIST criteria / clinical benefit (stable disease or partial response or complete response) (phase II)
时间窗: 12 weeks after start of treatment
次要结局
- Number of patients with Adverse Events(7 years)
- Evaluation of CA125 tumour response(7 years)
- Assessment of quality of life over time as defined by EORTC-QLQ C 30 and Ovar 28 questionnaire(7 years)
- Time to progression (TTP) according to RECIST criteria(7 years)
- Overall survival(7 years)
研究者
Priv.-Doz. Dr. med. Joachim Rom
PD Dr. med
University Hospital Heidelberg
研究点 (5)
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进行中（未招募）
不适用
Pazopanib and cyclophosphamide in patients with recurrent, pre-treated ovarian cancerThis study is a prospective open-label, non-randomized multicenter phase I/II trial in order to determine overall response rate of patients with platinum-resistant or refractory recurrent, pretreated epithelial ovarian cancer.EUCTR2009-017328-25-DEniversity Hospital Heidelberg