NCT00089648已完成2 期
A Phase 2 Study Of SU011248 In The Treatment Of Patients With Bevacizumab-Refractory Metastatic Renal Cell Carcinoma
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 61
- 试验地点
- 1
- 主要终点
- Number of Subjects With Overall Confirmed Objective Disease Response According to the Response Evaluation Criteria in Solid Tumors (RECIST)
研究概览
简要总结
The purpose of this study is to test whether sunitinib (SU011248) has activity and is safe in patients with renal cell carcinoma (RCC) who have failed prior therapy with bevacizumab (Avastin) -based treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically proven renal cell carcinoma of clear cell histology with metastases
- •Evidence of measurable disease
- •Radiographic evidence of disease progression during or within 3 months of completion of bevacizumab-based treatment
- •Prior radical or partial nephrectomy
排除标准
- •Prior treatment with any other anti-angiogenic therapy other than bevacizumab
- •Prior systemic treatment for RCC > 2 regimens
- •History of or known brain metastases
- •Serious acute or chronic illness or recent history of significant cardiac abnormality
研究组 & 干预措施
1
Experimental
干预措施: Sunitinib (Drug)
结局指标
主要结局
Number of Subjects With Overall Confirmed Objective Disease Response According to the Response Evaluation Criteria in Solid Tumors (RECIST)
时间窗: 4 week treatment cycles up to 1 year in absence of withdrawal criteria requiring discontinuation including 28 day post study follow up
Objective disease response = subjects with confirmed complete response (CR) or partial response (PR) according to RECIST. A CR was defined as the disappearance of all target lesions. A PR was defined as a ≥ 30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.
次要结局
- Time to Tumor Progression (TTP)(4 week treatment cycles up to 1 year in absence of withdrawal criteria requiring discontinuation including 28 day post study follow up)
- Duration of Response (DR)(4 week treatment cycles up to 1 year in absence of withdrawal criteria requiring discontinuation including 28 day post study follow up)
- Overall Survival (OS)(4 week treatment cycles up to 1 year in absence of withdrawal criteria requiring discontinuation including 28 day post study follow up)
- Progression Free Survival (PFS)(4 week treatment cycles up to 1 year in absence of withdrawal criteria requiring discontinuation including 28 day post study follow up)
- Trough Plasma Concentrations (Cmin) of Sunitinib(Day 28 of Cycle 1 to Cycle 4)
- Trough Plasma Concentrations (Cmin) of SU012662(Day 28 of Cycle 1 to Cycle 4)
- Trough Plasma Concentrations (Cmin) of Total Drug (Sunitinib + SU012662)(Day 28 of Cycle 1 to Cycle 4)
- Plasma Concentration of Vascular Endothelial Growth Factor-A (VEGF-A)(Cycle 1 (Days 1, 14, and 28), Cycle 2 (Day 1))
- Plasma Concentration of Soluble VEGF Receptor-3 (sVEGFR-3)(Cycle 1 (Days 1, 14, and 28), Cycle 2 (Day 1))
- Plasma Concentration of Placental Growth Factor (PlGF)(Cycle 1 (Days 1, 14, and 28))
- Plasma Concentration of VEGF-C(Cycle 1 (Days 1, 14, and 28))
- Plasma Concentration of Soluble VEGF Receptor-2(sVEGFR-2)(1 year)
研究者
研究点 (1)
Loading locations...
相似试验
终止
2 期
Evaluation of Sunitinib Malate in Patients With Von Hippel-Lindau Syndrome (VHL) Who Have VHL Lesions to FollowVon Hippel-Lindau SyndromeHemangioblastomaRenal Cell CarcinomaNCT00330564M.D. Anderson Cancer Center15
已完成
2 期
Phase II Trial of Sunitinib (SU011248) in Patients With Recurrent or Inoperable MeningiomaCNS CancerIntracranial HemangiopericytomaHemangioblastomaMeningiomaNeurofibromatosisNCT00589784Memorial Sloan Kettering Cancer Center50
已完成
2 期
Sunitinib Malate in Treating Patients With Persistent or Recurrent Clear Cell Ovarian CancerOvarian Clear Cell AdenocarcinomaRecurrent Ovarian CarcinomaNCT00979992National Cancer Institute (NCI)35
已完成
2 期
Sunitinib Malate in Treating Patients With Uterine Cervical Cancer That is Stage IVB, Recurrent, or Cannot Be Removed By SurgeryCervical AdenocarcinomaCervical Adenosquamous Cell CarcinomaRecurrent Cervical CancerStage IVB Cervical CancerCervical Squamous Cell CarcinomaNCT00389974National Cancer Institute (NCI)19
已完成
2 期
Sunitinib Malate in Treating Patients With Recurrent Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal CancerRecurrent Fallopian Tube CancerRecurrent Ovarian Epithelial CancerRecurrent Primary Peritoneal Cavity CancerStage IIIA Fallopian Tube CancerStage IIIA Ovarian Epithelial CancerStage IIIA Primary Peritoneal Cavity CancerStage IIIB Fallopian Tube CancerStage IIIB Ovarian Epithelial CancerStage IIIB Primary Peritoneal Cavity CancerStage IIIC Fallopian Tube CancerStage IIIC Ovarian Epithelial CancerStage IIIC Primary Peritoneal Cavity CancerStage IV Fallopian Tube CancerStage IV Ovarian Epithelial CancerStage IV Primary Peritoneal Cavity CancerNCT00388037National Cancer Institute (NCI)31