NCT00137436已完成1 期
A Phase 1/2 Safety And Pharmacokinetic Study Of SU011248 In Combination With Docetaxel (Taxotere) And Prednisone In Patients With Metastatic Hormone Refractory Prostate Cancer (HRPC)
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 93
- 试验地点
- 1
- 主要终点
- Percentage of Participants With Prostate Specific Antigen (PSA) Response
研究概览
简要总结
This is a multi-center, open-label, Phase 1/2 study of SU011248 (sunitinib malate, SUTENT) in combination with docetaxel and prednisone for the first-line treatment of metastatic hormone-refractory prostate cancer (mHRPC).
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
- Male
- 接受健康志愿者
- 否
入选标准
- •Histologically or cytologically confirmed adenocarcinoma of the prostate
- •Patients must have progressive hormone-refractory prostate cancer (HRPC): patients must have undergone primary hormone treatment (e.g. orchiectomy or gonadotropin releasing hormone analog with or without antiandrogens). For patients who received antiandrogen therapy, disease progression must have been determined after antiandrogen discontinuation
- •Progressive disease based on either non-measurable disease and an elevated PSA OR measurable disease
- •Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
排除标准
- •Prior thalidomide, anti-vascular endothelial growth factor (VEGF) therapy, VEGF receptor inhibitor, platelet-derived growth factor (PDGF) receptor inhibitor or anti-angiogenic treatment of any kind including investigational therapy
- •Prior chemotherapy
- •Uncontrolled pain at baseline, impending complication from bone metastasis (fracture and/or compression) and/or presence of urinary obstruction (urinary retention, hydronephrosis)
- •History of cardiac dysfunction, QT interval corrected for heart rate (QTc) >450 msec
- •Central Nervous System (CNS) involvement
研究组 & 干预措施
A
Experimental
SU011248 in combination with docetaxel and prednisone
干预措施: Docetaxel (Drug)
A
Experimental
SU011248 in combination with docetaxel and prednisone
干预措施: Prednisone (Drug)
A
Experimental
SU011248 in combination with docetaxel and prednisone
干预措施: SU011248 (Drug)
结局指标
主要结局
Percentage of Participants With Prostate Specific Antigen (PSA) Response
时间窗: Baseline, Day 1 of each 21-day cycle
PSA response rate, which is defined as a greater than or equal to a 50% decrease in PSA from baseline, that is subsequently confirmed.
次要结局
- Time to PSA Progression(Baseline to first documentation of PSA progression up to 28 days after date of last dose)
- Duration of PSA Response (DPR)(Baseline to first documentation of PSA progression up to 28 days after date of last dose)
- Percentage of Participants With Objective Response Rate (ORR)(Baseline to first documentation of PSA progression up to 28 days after date of last dose)
- Ratio to Baseline (Bsl) in Median Levels of Soluble Protein Biomarkers by Prostate Specific Antigen (PSA) Response: VEGFC(Baseline (Cycle 1 Day 1 [C1.D1]), C1.D14, C2.D1, C2.D14, C3.D1, C3.D14)
- Ratio to Baseline in Median Levels of Soluble Protein Biomarkers by Prostate Specific Antigen (PSA) Response: VEGFR2(Baseline (C1.D1), C1.D14, C2.D1, C2.D14, C3.D1, C3.D14)
- Ratio to Baseline in Median Levels of Soluble Protein Biomarkers by Prostate Specific Antigen (PSA) Response: VEGFR3(Baseline (C1.D1), C1.D14, C2.D1, C2.D14, C3.D1, C3.D14)
- Ratio to Baseline in Median Levels of Soluble Protein Biomarkers by Clinical Benefit Response (CBR): VEGFC(Baseline (C1.D1), C1.D14, C2.D1, C2.D14, C3.D14)
- Ratio to Baseline in Median Levels of Soluble Protein Biomarkers by Clinical Benefit Response (CBR): VEGFR2(Baseline (C1.D1), C1.D14, C2.D1, C2.D14, C3.D14)
- Ratio to Baseline in Median Levels of Soluble Protein Biomarkers by Clinical Benefit Response (CBR): VEGFR3(Baseline (C1.D1), C1.D14, C2.D1, C2.D14, C3.D14)
- Change From Baseline in Modified Brief Pain Inventory-Short Form (mBPI-sf) : Pain Intensity (Questions 2-5)(Baseline (C1.D1), Day 1 of Cycles 2 through 16, and End of Treatment (EOT=following Cycle 16 or within 7 days of withdrawal from study))
- Change From Baseline in Modified Brief Pain Inventory-Short Form (mBPI-sf): Pain Interference (Questions 7A Through 7G)(Baseline (C1.D1), Day 1 of Cycles 2 through 16, and End of Treatment (EOT=following Cycle 16 or within 7 days of withdrawal from study))
- Change From Baseline in Functional Assessment of Cancer Therapy-Prostate (FACT-P) Questionnaire (FACT-General and Prostate Cancer Subscale)(Baseline (C1.D1), Day 1 of Cycles 2 through 16, and End of Treatment (EOT=following Cycle 16 or within 7 days of withdrawal from study))
- Preliminary Assessment of PSA Modulation by SU011248(Baseline to Day 28)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
1 期
Study Of SU011248 Plus Gefitinib (Iressa) In Patients With Advanced Renal Cell CarcinomaCarcinoma, Renal CellNCT00113529Pfizer42
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
1 期
Study Of SU011248 In Combination With Docetaxel In Patients With Advanced CancerAdvanced Solid TumorsNon Small Cell Lung CancerNCT00712504Pfizer49
已完成
1 期
A Phase I/II Study of Sunitinib Malate (SU011248) In Patients With Gastrointestinal Stromal Tumor (GIST)Gastrointestinal Stromal TumorsNCT00457743Pfizer36
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