EUCTR2007-000779-40-DK进行中（未招募）1 期
A Phase II Trial of Pazopanib, a Pan Vascular Endothelial Growth Factor Receptor (VEGFR) Inhibitor, in Relapsed or Refractory Small Cell Lung Cancer (SCLC)
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 60
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)Diagnosis of SCLC based on either histology or cytology (by FNA) with radiologically-confirmed progressive disease after first-line chemotherapy.
- •3) Only one prior chemotherapy regimen. Please refer to protocol for further information.
- •4) Presence of brain metastases is permitted if subject has completed treatment with surgery and/or radiation more than four weeks prior to date of first dose of study drug and is stable off steroids for at least one week prior to date of first dose of study drug. Subjects who have developed brain metastases following prophylactic cranial irradiation will not be eligible for participation.
- •5) Age = 18 years
- •6) Eastern Cooperative Oncology Group (ECOG) performance status of = 2.
- •7)Ability to swallow and retain oral medication.
- •8) Disease must be measurable according to RECIST [Therasse, 2000].
- •9) Adequate organ system function as defined in the protocol
- •10) A female is eligible to enter and participate in this study if meets the criteria defined in the protocol. A male with a female partner of childbearing potential is eligible to enter and participate in the study if he uses a barrier method of contraception or abstinence during the study.
- •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) Prior malignancy
- •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 one week prior to first dose of study drug. Screening with CNS imaging studies (computed tomography [CT] or magnetic resonance imaging [MRI]) is required .
- •3) Clinically significant gastrointestinal abnormalities as outlined in the protocol.
- •4)Presence of uncontrolled infection.
- •5)Prolongation of corrected QT interval (QTc) >480msecs.
- •6) 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, Class III or IV congestive heart failure, as defined by the New York Heart Association (NYHA) (See Appendix 4 for description).
- •7) Poorly controlled hypertension (defined as systolic blood pressure [SBP] of =140mmHg or diastolic blood pressure [DBP] of = 90mmHg).
- •8) History of cerebrovascular accident including transient ischaemic attack (TIA), pulmonary embolism or insufficiently treated deep venous thrombosis (DVT) within the past 6 months.
- •9) Prior major surgery or trauma within 28 days prior to first dose of study drug and/or presence of any non-healing wound, fracture, or ulcer.
- •10) Evidence of active bleeding or bleeding diathesis.
- •11) Hemoptysis in excess of 2.5mL within 8 weeks of first dose of study drug.
- •12) 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.
- •13) Use of any prohibited medication within the timeframes listed in Section 5.7.2.
- •14) Use of an investigational agent, including an investigational anti-cancer agent, within 28 days or 5 half-lives, whichever is longer, prior to the first dose of study drug.
- •15) Prior use of an investigational or licensed drug that targets VEGF or VEGF receptors.
- •16) Is now undergoing and/or has undergone in the 14 days immediately prior to first dose of study drug, any cancer therapy (surgery, tumor embolization, chemotherapy, radiation therapy, immunotherapy, biological therapy, or hormonal therapy).
- •17) Any ongoing toxicity from prior anti-cancer therapy that is >Grade 1 and/or that is progressing in severity.
- •18) Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to pazopanib.
研究者
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