EUCTR2009-017328-25-DE进行中（未招募）不适用
A phase I/II study of pazopanib (GW786034) and cyclophosphamide in patients with platinum-resistant recurrent, pre-treated ovarian cancer - PACOVAR
niversity Hospital Heidelberg0 个研究点开始时间: 2010年7月28日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
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.Subjects must provide written informed consent prior to performance of study specific procedures or assessments, and must be willing to comply with treatment and follow up assessments and procedures.
- •2.Female subjects =18 years of age
- •3.Histologically or cytologically confirmed diagnosis of: epithelial ovarian cancer which is platinum resistant (relapse-free interval < 6 months of a platinum-containing primary or secondary platinum therapy) or platinum refractory (progressive disease during primary or secondary platinum therapy), cancer of the fallopian tube, peritoneal cancer
- •4.Patients must have failed available standard chemotherapy regimen (except if medically contraindicated or refused by the patient)
- •5.Prior treatment with at least 2 chemotherapy regimens in advanced tumor setting
- •6.Performance status ECOG 0 2
- •7.Adequate contraception
- •8.Adequate organ function defined as in Table 1:
- •Table 1Definitions of Adequate Organ Function
- •9.Measurable disease according to RECIST criteria.
- •10.Able to swallow and retain oral medication.
- •11.A life expectancy of at least 12 weeks
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.Diagnosis of 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
- •2.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. Screening with CNS imaging studies (computed tomography [CT] or magnetic resonance imaging [MRI]) is required only if clinically indicated or if the subject has a history of CNS metastases.
- •3.Clinically significant gastrointestinal abnormalities which might interfere with oral dosing
- •4.Any unstable or serious concurrent condition (e.g., active infection requiring systemic therapy).
- •5.Prolongation of corrected QT interval (QTc) >480 msecs.
- •6.History of any one or more of the following cardiovascular conditions within the past 6 months:
- •7.Macroscopic hematuria
- •8.Hemoptysis that is clinically relevant within 4 weeks of first dose of study drug
- •9.Evidence of active bleeding or bleeding diathesis
- •10.Known endobronchial lesions or involvement of large pulmonary vessels by tumor
- •11.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.
- •12.Chemotherapy or radiation therapy within 2 weeks prior to the first dose of study drug.
- •13.Biological therapy, hormonal therapy or treatment with an investigational agent within 28 days or 5 half-lives, whichever is longer prior to the first dose of study drug.
- •14.Prior antiangiogenic therapy.
- •15.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
- •16.Any ongoing toxicity from prior anti-cancer therapy that is > Grade 1 and/or that is progressing in severity.
- •17.Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to pazopanib
- •18.Psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol.
- •19.Pregnancy (for women of childbearing potential absence to be confirmed by ß-hCG test) or lactation period or missing contraception of women of childbearing potential (Pearl-Index < 1, e.g. hormonal contraception including the combined oral contraceptive pill, the transdermal patch, and the contraceptive vaginal ring, intrauterine devices or sterilization) during treatment and for at least 6 months thereafter.
- •20.More than 3 different chemotherapy regimens in advanced tumor setting
- •21.Uncontrolled hypertension
- •22.History of ischemic event (stroke, myocardial infarction, unstable angina, TIA, symptomatic peripheral vascular disease)
- •23.History or clinical evidence of thrombo-embolic event
- •24.Active bleeding
- •25.Signs/Suspicion of intestinal obstruction
研究者
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