EUCTR2014-003127-22-ES进行中（未招募）不适用
Phase II study with pazopanib and weekly paclitaxel in metastatic or locally advanced squamous penile carcinoma patients previously treated with cisplatin based chemotherapy - PAZOPE
SOGUG (Spanish Oncology Genitourinary Group)0 个研究点开始时间: 2014年11月4日最近更新:
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
入排标准
- 性别
- Male
入选标准
- •1. Written informed consent
- •2. Age >= 18 years
- •3. Histologically confirmed diagnosis of squamous cell carcinoma of the penis
- •4. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
- •5. Measurable disease criteria according to RECIST criteria (version 1.1)
- •6. Progressive disease after treatment with cisplatin or carboplatin based chemotherapy. At least two cycles of chemotherapy had been administered either in neoadyuvant, adyuvant or metastatic setting.
- •7. Archived tumor tissue must be provided for all subjects for biomarker analysis before and/or during treatment with investigational product.
- •8. Adequate organ system function
- •- Haemoglobin >= 9.0 gr/dl (5.6 mmol/L) and stable in the previous 4 weeks to start study treatment
- •- Neutrophils >= 1.5 x 10*9/L
- •- Platelets >= 100 x 10*9/L
- •- Total bilirubin <= 1.5 x UNL
- •- AST/SGOT and ALT/SGPT <= 2.5 x UNL
- •9. Normal coagulation tests:
- •- Prothrombin time (PT) or international normalized ratio (INR) <= 1.2 X ULN
- •- Activated partial thromboplastin time (aPTT) <= 1.2 X ULN
- •10. Are able to swallow and retain oral tablets
- •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 16
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 16
排除标准
- •1. Prior malignancy.
- •2. Central nervous system metastases at baseline, with the exception of those subjects who have previously-treated CNS metastases (surgery ± radiotherapy, radiosurgery, or gamma knife) and who meet both of the following criteria: a) are asymptomatic and b) have no requirement for steroids or enzyme-inducing anticonvulsants
- •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 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)
- •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.
- •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 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
- •12. Recent hemoptysis (>= 1/2 teaspoon [2.5 mL]) 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 subjects safety, provision of informed consent, or compliance to study procedures.
- •14. Unable or unwilling to discontinue use of prohibited medications 14 days 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 OR
- •- chemotherapy, immunotherapy, biologic therapy, investigational therapy or hormonal therapy within 14 days prior to the first dose of Pazopanib
- •16. Administration of any non-oncologic investigational drug within 30 days 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.
- •18. Have a known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to pazopanib or paclitaxel and/or excipients that contraindicates their participation.
- •19. Previous taxane or/and antiVEGF treatment would not allow patient to participate in the study.
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