EUCTR2011-001192-39-GB进行中（未招募）1 期
An Open-label Study of Sipuleucel-T in European Men with Metastatic, Castrate Resistant Prostate Cancer - Sipuleucel-T Manufacturing Demonstration Study, ver .01
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 47
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
入选标准
- •1.Written informed consent obtained prior to the initiation of study procedures.
- •2.Males, age = 18 years at the time of registration
- •3.Histologically documented adinocarcinoma of the prostate.
- •4. Metastatic diseaseas evidenced by soft tissue and/or bony metastases on bone scan and/or computed tomography (CT) scan of the abdomen and pelvis at any time prior to registration. (Subjects whose metastatic disease is detectable only on chest CT scan are not eligible).
- •5.Castrate resistant prostate cance, subjects must have current or historical evidence of disease progression concomitant with surgical or medical castration, as demonstrated by PSA progression or progression of measurable diseae or progression of non-measurable disease as defined below:
- •- PSA: Two consecutive PSA values, at least 14 days apart, each =5.0 ng/mL and = 50% above the minimum PSA observed during castration therapy or above the pre-treatment value if there was no response.
- •-Measurable disease: =50% increase in the sum of the cross products of all measurable lesions or the development of any new lesions. The change will be measured
- •against the best response to castration therapy or against the pre-castration studies if there was no response.
- •-Non-measurable disease:
- •-Soft tissue disease: the appearance of 1 or more new lesions, and/or unequivocal worsening of non-measurable disease when compared to imaging studies acquired during castration therapy or against the pre-castration studies if there was no response.
- •-Bone disease: Apprearance of 2 or more new areas of abnormal uptake on bone scan when compared to imaging studies acquired during castration therapy or against the pre-castration studies if there was no response.Increase uptake of pre-exsisting lesions on bone scan does not constitute progression.
- •6. Castration levels of testosterone (=50ng/dl; =1.74 nmol/L) achieved via medical or surgical castration. Surgical castration must have occurred at least 3 months prior to registration. Subjects who are not surgically castrated must be receiving medical castration therapy, have initiated such therapy at least 3 months prior to registration, and continue such therapy during their participation on this study.
- •7.Serum PSA = 5.0 µg/L
- •8.ECOG performance status =1
- •9.Adequate hematologic, renal, and liver function as evidenced by the following:
- •White blood cell count =2,500 cell/µL
- •Absolute neutrophil count =1000 cell/µL
- •Platelet count =1000,000 cell/µL
- •Hemoglobin =10.0g/dL
- •Creatinine =2.0 mg/dL
- •Total Bilirubin =2 x Upper limit of normal (ULN)
- •Aspartate aminotransferase (AST, SGOT) =2.5 x ULN
- •Alanine aminotransferase (ALT, SGPT) =2.5 x ULN
- •10. Negative Serology tests indicating no active infection with human immunodeficiency virus types 1 and 2 (HIV -1/2), human T cell lymphotrophic virus types 1 and 2 (HTLV –I/II), and Hepatitis B and C viruses.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 20
排除标准
- •1. The presence of known brain metastases. In the case of suspected or questionable findings, the Investigator must address each findings in the subject’s medical record prior to registration
- •2. A requirement for systemic immunosuppressive therapy for any reason.
- •3. Treatment with any investigational vaccine within 2 years prior to registration
- •4. Any previous treatment with sipuleucel-T
- •5. Any previous treatment with ipilimumab (Yervoy, MDX-010, or MDX-101) or denosumab (Xgeva).
- •6. Pathologic long-bone fractures, imminent pathologic long-bone fracture (cortical erosion on radiography >50%), or spinal cord compression.
- •7. Subject with known malignancies other than prostate cancer that are likely to require treatment within 6 months of registration.
- •8. A history of allergic reactions attributed to compounds of similar chemical or biologic composition to sipuleucel-T or GM-CSF.
- •9. More than 2 chemo regimens to any time prior to registration
- •10. Treatment with any of the following medicated or interventions within 28 days of registration:
- •-Systemic corticosteroids; use of inhaled, intranasal, intra-articular, and topical steroids is acceptable, as is a short course (i.e. < 1 day) of corticosteroids to prevent a reaction to the IV contract used for CT scans.
- •-Non-steroidal anti-androgens (e.g., bicalutamide, flutamide, or nilutamide).
- •-External beam radiation therapy or major surgery requiring general anesthetic.
- •-Any other systemic therapy for porstate cancer including secondary hormonal therapies, such as mogestrol acetate (Megace), diethylstilbestrol (Des), and ketoconazole, medical castration therapy is not exclusionary
- •-Immunosuppressive therapy
- •-Treatment with any other investigational product
- •11. Any injection requiring pareteral antibiotic therapy or causing fever (temp >100.5 °F or 38.1°C) within 7 days prior to registration.
- •12. Any medical intervention or other condicition which, in the opinion of the Investigator or the Dendreon Medical Monitor, could compromise adherence, with study requirements or otherwise compromise the study’s objectives.
研究者
相似试验
进行中（未招募）
不适用
Sipuleucel-T Manufacturing Demonstration Studymetastatic castrate resistant prostate cancerMedDRA version: 14.1Level: LLTClassification code 10062904Term: Hormone-refractory prostate cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 14.1Level: LLTClassification code 10036916Term: Prostate cancer stage DSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 14.1Level: LLTClassification code 10066489Term: Progression of prostate cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 14.1Level: PTClassification code 10036909Term: Prostate cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 14.1Level: LLTClassification code 10036910Term: Prostate cancer NOSSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2011-001192-39-NLDendreon Corporation45
已完成
2 期
Sipuleucel-T Manufacturing Demonstration StudyCancer of ProstateCancer of the ProstateNeoplasms, ProstateNeoplasms, ProstaticProstate NeoplasmsProstatic CancerProstate CancerNCT01477749Dendreon47
进行中（未招募）
1 期
Study of Tislelizumab in Patients with Relapsed or Refractory Hodgkin LymphomaRefractory/relapse Hodgkin LymphomaMedDRA version: 20.0Level: LLTClassification code 10020328Term: Hodgkin's lymphomaSystem Organ Class: 100000004864EUCTR2019-002105-22-ESBeiGene Ltd.100
进行中（未招募）
1 期
Study of Tislelizumab in Patients with Relapsed or Refractory Hodgkin LymphomaEUCTR2019-002105-22-FRYSARC100
进行中（未招募）
不适用
A Pan-European, open label, randomised study comparing the efficacy and cost-effectiveness of Symbicort Maintenance and Reliever Therapy (Symbicort SMART) using a maintenance dose of Symbicort 160/4.5 micrograms of 1 or 2 inhalations twice daily in the treatment of persistent asthma. EUROSMART - EUROSMARTPersistent asthma.MedDRA version: 9.1Level: LLTClassification code 10003553Term: AsthmaEUCTR2006-006512-30-DKAstraZeneca AB8,250