EUCTR2012-002745-38-DE进行中（未招募）1 期
Phase II Clinical Trial of Pazopanib to evaluate the activity and tolerability in patients with advanced and/or metastatic liposarcoma who have relapsed following standard therapies or for whom no standard therapy exists
Grupo Español de Investigacion en Sarcomas0 个研究点目标入组 74 人开始时间: 2013年2月25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
- 74
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
- All
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.
- •2.Age ? 18 years or legal age of consent if greater than 18 years
- •3.Histological confirmed diagnosis of high or intermediate grade malignant liposarcoma with metastatic or locally advanced disease. Formaline fixed paraffin embedded tumour block and/or representative H/E (haematoxylin/eosin) slides must be available for central pathologic review.
- •4.Patient must have documentation of disease progression within 6 months prior to study entry.
- •5.Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
- •6.Measurable disease by RECIST v1.1 criteria. At least one measurable lesion located outside of a previously irradiated area. If the only measurable lesion is in a previously irradiated area, RECIST progression should be documented after radiotherapy, in the previous 6 months before study entry.
- •7.The patient should not be considered eligible for surgery or radical radiotherapy. e.g. Patients to whom surgery/radiotherapy can not be performed with a curative intent due to the extension of the disease. In the case of radiotherapy, it may also be limited due to a previous treatment with radiotherapy in the same area.
- •8.The patient must have either been considered ineligible for systemic chemotherapy or received at least one previous regimen for relapsed, refractory or metastatic disease. A maximum of three previous lines for advanced/metastatic disease are allowed.
- •9.The patient should be able to swallow and retain study drug
- •10.Adequate organ system function as defined in Table 1 of protocol.
- •11.A subject is eligible to enter and participate in this study if she/he is following the contraceptive indication detailed in protocol.
- •12.LVEF above the lower limit of normal for the institution, based on ECHO or MUGA.
- •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 74
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 74
排除标准
- •1.Prior history of malignancies other than liposarcoma.
- •Subjects who have had another malignancy and have been disease-free for 3 years, or subjects with a history of completely resected non-melanomatous skin carcinoma or successfully treated in situ carcinoma are eligible.
- •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 that may increase the risk for gastrointestinal bleeding.
- •4.Clinically significant gastrointestinal abnormalities that may affect absorption of investigational product.
- •5.Corrected QT interval (QTc) > 480 msecs
- •6.History of any one or more of cardiovascular conditions within the past 6 months.
- •7.Poorly controlled hypertension [defined as systolic blood pressure (SBP) of ?140 mmHg or diastolic blood pressure (DBP) of ? 90mmHg].
- •8.History of cerebrovascular accident including transient ischemic attack (TIA), pulmonary embolism or untreated deep venous thrombosis (DVT) within the past 6 months.
- •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 first dose of investigational product and/or presence of any non-healing wound, fracture, or ulcer (procedures such as catheter placement not considered to be major surgery).
- •10.Evidence of active bleeding or bleeding diathesis.
- •11.Known endobronchial lesions and/or lesions infiltrating major pulmonary vessels that increase the risk of pulmonary hemorrhage.
- •Lesions infiltrating major pulmonary vessels (contiguous tumour and vessels) are excluded; however, the presence of a tumor that is touching, but not infiltrating (abutting) the vessels is acceptable (CT with contrast is strongly recommended to evaluate such lesions).
- •12.Recent hemoptysis (? ½ teaspoon of red blood within 8 weeks before first dose of study drug).
- •13.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.
- •14.Unable or unwilling to discontinue use of prohibited medications listed in section 7.4 of this protocol or 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.
- •15.Treatment with any of the following anti-cancer therapies:
- •radiation therapy, surgery or tumor embolization within 14 days prior to the first dose of Pazopanib
- •chemotherapy, immunotherapy, biologic therapy, investigational therapy or hormonal therapy within 14 days or five half-lives of a drug (whichever is longer) prior to the first dose of Pazopanib
- •16.Administration of any non-oncologic investigational drug within 30 days or 5 half lives whichever is longer prior to receiving the first dose of study treatment
- •17.Any ongoing toxicity from prior anti-cancer therapy that is >Grade 1 and/or that is progressing in severity, except alopecia.
研究者
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