EUCTR2005-002097-30-SI进行中（未招募）1 期
A SU011248 EXPANDED ACCESS PROTOCOL FOR SYSTEMIC THERAPY OF PATIENTS WITH METASTATIC RENAL CELL CARCINOMA WHO ARE INELIGIBLE FOR PARTICIPATION IN OTHER SU011248 PROTOCOLS BUT MAY DERIVE BENEFIT FROM TREATMENT WITH SU011248
PFIZER Inc 235 East 42nd Street, New York, NY, 100170 个研究点开始时间: 2005年12月21日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 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
- All
入选标准
- •Patients must meet all of the following inclusion criteria to be eligible for enrollment into the trial:
- •1.Histopathologically confirmed renal cell carcinoma with metastases.
- •2.Must be ineligible for participation in ongoing SU011248 clinical studies (if any Phase 1, 2 or 3 SU011248 protocols for patients having RCC are open to enrollment at the institution).
- •3.Judged by the treating physician to have the potential to derive clinical benefit from SU011248 treatment.
- •4.Male or female, 18 years of age or older.
- •5.If previously treated for metastatic RCC, resolution of all acute toxic effects of prior systemic therapy, radiotherapy or surgical procedure to NCI CTCAE Version 3.0 grade less/equal to 1.
- •6.Adequate organ function as defined by the following criteria:
- •Total serum bilirubin less/equal to 2 x ULN (patients with Gilbert’s disease exempt)
- •Serum transaminases <5 x ULN
- •Serum creatinine less/equal 2 x ULN
- •Absolute neutrophil count (ANC) major/equal to 1000/mL without growth factor support
- •Platelets major/equal to 75,000/mL
- •Hemoglobin major/equal to 8.0 g/dL
- •7.Signed and dated informed consent document indicating that the patient (or legally acceptable representative) has been informed of all the pertinent aspects of the trial prior to enrollment.
- •8.Willingness and ability to comply with scheduled visits, treatment plans and laboratory tests and other study procedures.
- •9. As required by local regulations, eg, United Kingdom, ECOG performance status of 0, 1 or 2.
- •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.Current treatment in another therapeutic clinical trial
- •2.Congestive heart failure, myocardial infarction or coronary artery bypass graft in the previous six months, ongoing severe or unstable angina or any unstable arrhythmia requiring medication
- •3.Previous treatment on a SU011248 trial except for those patients who recieved IFN-alpha therapy in Protocol A6181034 and either had radiographic documentation of disease progression or were IFN-alpha intolerant.
- •4.Pregnancy or breastfeeding. Patients must be surgically sterile or be postmenopausal, or must agree to use effective contraception during the period of therapy. The definition of effective contraception will be based on the judgment of the principal investigator or a designated associate. Male patients must be surgically sterile or agree to use effective contraception.
- •5.Other severe acute or chronic medical or psychiatric condition, or laboratory abnormality that would impart, in the judgment of the investigator, excess risk associated with study participation or study drug administration, or which, in the judgment of the investigator, would make the patient inappropriate for entry into this study
研究者
相似试验
进行中（未招募）
不适用
A SU011248 EXPANDED ACCESS PROTOCOL FOR SYSTEMIC THERAPY OF PATIENTS WITH METASTATIC RENAL CELL CARCINOMA WHO ARE INELIGIBLE FOR PARTICIPATION IN OTHER SU011248 PROTOCOLS BUT MAY DERIVE BENEFIT FROM TREATMENT WITH SU011248.EUCTR2005-002097-30-FIPfizer Inc.5,000
进行中（未招募）
不适用
A SU011248 EXPANDED ACCESS PROTOCOL FOR SYSTEMIC THERAPY OF PATIENTS WITH METASTATIC RENAL CELL CARCINOMA WHO ARE INELIGIBLE FOR PARTICIPATION IN OTHER SU011248 PROTOCOLS BUT MAY DERIVE BENEFIT FROM TREATMENT WITH SU011248EUCTR2005-002097-30-DEPfizer Pharma GmbH5,000
进行中（未招募）
不适用
A SU011248 EXPANDED ACCESS PROTOCOL FOR SYSTEMIC THERAPY OF PATIENTS WITH METASTATIC RENAL CELL CARCINOMA WHO ARE INELIGIBLE FOR PARTICIPATION IN OTHER SU011248 PROTOCOLS BUT MAY DERIVE BENEFIT FROM TREATMENT WITH SU011248Histopathologically confirmed renal cell carcinoma with metastases.MedDRA version: 14.1Level: LLTClassification code 10038415Term: Renal cell carcinoma stage unspecifiedSystem Organ Class: 100000004864EUCTR2005-002097-30-ITPFIZER5,000
进行中（未招募）
1 期
A SU011248 EXPANDED ACCESS PROTOCOL FOR SYSTEMIC THERAPY OF PATIENTS WITH METASTATIC RENAL CELL CARCINOMA WHO ARE INELIGIBLE FOR PARTICIPATION IN OTHER SU011248 PROTOCOLS BUT MAY DERIVE BENEFIT FROM TREATMENT WITH SU011248Histopathologically confirmed renal cell carcinoma with metastasesMedDRA version: 8.0 Level: LLT Classification code 10038415EUCTR2005-002097-30-GBPFIZER Inc 235 East 42nd Street, New York, NY, 100175,000
已完成
不适用
Treatment Use Study With Sunitinib (SU011248) For Patients With Cytokine-Refractory Metastatic Renal Cell Carcinoma-C64 Malignant neoplasm of kidney, except renal pelvisMalignant neoplasm of kidney, except renal pelvisC64PER-019-06PFIZER S.A.,