EUCTR2012-003810-15-DE进行中（未招募）1 期
Pazopanib versus Pazopanib plus Gemcitabine in patients with relapsed or metastatic uterine leiomyosarcomas or other uterine tumour: a multi-center, randomized phase-II clinical trial of the NOGGO and AGO - PazoDoble
OGGO e.V.0 个研究点目标入组 107 人开始时间: 2013年7月23日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 107
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 informed consent prior to performance of study-specific procedures or assessments, and must be willing to comply with treatment and follow-up. Procedures conducted as part of the subject’s routine clinical management (e.g., blood count, imaging study) and obtained prior to signing of informed consent may be utilized for screening or baseline purposes provided these procedures are conducted as specified in the protocol
- •2.Histologically or cytological confirmed uterine leiomyosarcoma or uterine carcinosarcoma including any subtypes
- •3.Patient must have received one or two prior chemotherapies
- •4.For patients with prior anthracycline therapy normal cardiac function with LVEF at least 50% must be assessed by quantitative echocardiogram or MUGA scan
- •5.Prior Gemcitabine containing chemotherapy is permitted provided that at least 8 weeks have elapsed since the last dose of therapy
- •6.ECOG performance status 0-1
- •7.At least 18 years old
- •8.Measurable disease according to RECIST v 1.1 criteria (in case of tumour debulking - staging CT-scan after surgery)
- •9.Able to swallow and retain oral medication
- •10.Adequate organ system function
- •11.Non-childbearing potential or negative serum pregnancy test of women of childbearing potential
- •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 80
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 27
排除标准
- •1.Prior malignancy except disease-free for 5 years, or subjects with a history of completely resected non-melanomatous skin carcinoma or successfully treated in situ carcinoma are eligible.
- •2.Prior treatment with any anti-angiogenic agent including bevacizumab and tyrosine kinase inhibitors
- •3.Active malignancy or any malignancy in the last 5 years prior to first dose of study drug other than LMS and CS
- •4.History or clinical evidence of central nervous system (CNS) or leptomeningeal metastases, 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
- •5.Clinically significant gastrointestinal abnormalities that may increase the risk for gastrointestinal bleeding including, but not limited to:
- •Active peptic ulcer disease
- •Known intraluminal metastatic lesion/s with risk of bleeding
- •Inflammatory bowel disease (e.g. ulcerative colitis, Crohn’s disease), or other gastrointestinal conditions with increased risk of perforation
- •History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 28 days prior to beginning study treatment
- •Grade 3/4 diarrhea
- •6.Corrected QT interval (QTc) > 480 msecs using Barzett’s formula
- •7.History of any one or more of the following cardiovascular conditions within the past 6 months:
- •Cardiac angioplasty or stenting
- •Myocardial infarction
- •Unstable angina
- •Coronary artery bypass graft surgery
- •Symptomatic peripheral vascular disease
- •Class III or IV congestive heart failure, as defined by the New York Heart Association (NYHA)
- •Poorly controlled hypertension [defined as systolic blood pressure (SBP) of =140 mmHg or diastolic blood pressure (DBP) of = 90 mmHg].
- •8.History of cerebrovascular accident including transient ischemic attack (TIA), pulmonary embolism or untreated deep venous thrombosis (DVT) within the past 6 months.
- •Note: Subjects with recent DVT who have been treated with therapeutic anti-coagulating agents for at least 6 weeks are eligible
- •9.Major surgery or trauma within 28 days prior to study enrolment or any non- healing wound, fracture or ulcer (procedures such as catheter placement not considered to be major)
- •10.Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to Pazopanib or Gemcitabine
- •11.Evidence of active bleeding or bleeding diathesis
- •12.Known endobronchial lesions and/or lesions infiltrating major pulmonary vessels
- •13.Hemoptysis in excess of 2.5 mL(or one half teaspoon) within 8 weeks prior to the first dose of study drug
- •14.Any serious and/or unstable pre-existing medical, psychiatric, or other condition that could interfere with subject’s safety, provision of informed consent, or compliance to study procedures
- •15.Unable or unwilling to discontinue use of prohibited medications listed in the study protocol for at least 14 days or five half-lives of a drug (whichever is longer) prior to the first dose of study drug and for the duration of the study
- •16.Treatment with any of the following anti-cancer therapies
- •- Radiation therapy, surgery or tumour embolization within 14 days prior to the first dose of study drug
- •- Chemotherapy, immunotherapy, biologic therap
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