NCT01525550已完成4 期
A SINGLE-ARM OPEN-LABEL INTERNATIONAL MULTI-CENTER STUDY OF THE EFFICACY AND SAFETY OF SUNITINIB MALATE (SU011248, SUTENT (REGISTERED)) IN PATIENTS WITH PROGRESSIVE ADVANCED METASTATIC WELL-DIFFERENTIATED UNRESECTABLE PANCREATIC NEUROENDOCRINE TUMORS
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 106
- 试验地点
- 26
- 主要终点
- Progression-Free Survival (PFS): Investigator Assessment
研究概览
简要总结
The purpose of this study is to confirm the safety and efficacy of sunitinib in subjects with unresectable pancreatic neuroendocrine tumors.
详细描述
This study is being conducted to meet regulatory post-marketing commitments.
研究设计
- 研究类型
- Interventional
- 主要目的
- Other
- 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 or cytologically proven diagnosis of well-differentiated pancreatic neuroendocrine tumor (according to World Health Organization [WHO 2000] classification).
- •Disease progression within 12 months prior to study enrollment.
- •Disease that is not amenable to surgery, radiation, or combined modality therapy with curative intent.
排除标准
- •Patients with poorly differentiated pancreatic neuroendocrine tumors (according to WHO 2000 classification).
- •Prior treatment with any tyrosine kinase inhibitors, anti vascular endothelial growth factor (VEGF) angiogenesis inhibitors, non VEGF targeted angiogenesis inhibitors, or mammalian target of rapamycin (mTOR) inhibitors.
研究组 & 干预措施
sunitinib
Experimental
干预措施: sunitinib (Drug)
结局指标
主要结局
Progression-Free Survival (PFS): Investigator Assessment
时间窗: Baseline until disease progression or death due to any cause (up to 1226 days)
Investigator assessed PFS was defined as the time (in months) from the date of enrollment in study to the date of first documented objective tumor progression or death (due to any cause), whichever occurs first. PFS calculated as (first event date minus date of enrollment plus 1)/30.4. If progression or death was not observed, the participant was censored at the date of the participant's last progression-free tumor assessment prior to the study cut-off date. Progression as per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0 criteria was defined as: greater than or equal to (\>=) 20 percent increase in sum of longest diameter (LD) of target lesions taking as a reference the smallest sum of the LD recorded since the treatment started, or the appearance of one or more new lesions and/or unequivocal progression of existing non target-lesions. The analysis was performed by Kaplan-Meier method.
次要结局
- Time to Tumor Progression (TTP): Investigator Assessment(Baseline until first documented tumor progression (up to 1226 days))
- Percentage of Participants With Chromogranin A (CgA) Response(Baseline until CgA response or death due to any cause (up to 1226 days))
- Overall Survival (OS)(Baseline until death or end of study (up to 1939 days))
- Percentage of Participants With Objective Response (OR): Investigator Assessment(Baseline until disease progression or death due to any cause (up to 1226 days))
- Duration of Response (DOR): Investigator Assessment(Baseline until disease progression or death due to any cause (up to 1226 days))
- Time to Tumor Response (TTR): Investigator Assessment(Baseline until first documented objective tumor response (up to 1226 days))
- Time to Tumor Response (TTR): Independent Radiological Review (IRR) Assessment(Baseline until first documented objective tumor response (up to 1226 days))
- Percentage of Participants With Objective Response (OR): Independent Radiological Review (IRR) Assessment(Baseline until disease progression or death due to any cause (up to 1226 days))
- Progression-Free Survival (PFS): Independent Radiological Review (IRR) Assessment(Baseline until disease progression or death due to any cause (up to 1226 days))
- Duration of Response (DOR): Independent Radiological Review (IRR) Assessment(Baseline until disease progression or death due to any cause (up to 1226 days))
- Minimum Observed Plasma Concentration (Ctrough) of Sunitinib and Its Metabolite SU012662(Pre-dose on Day 15 of Cycle 1, Day 1 of Cycle 2, 3 and 5)
- Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)(Day 1 of Cycle 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, End of treatment (up to maximum duration of 1226 days))
- Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)(Day 1 of Cycle 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, End of treatment (up to maximum duration of 1226 days))
- Plasma Concentration of Soluble Protein Biomarker (sKIT)(Pre-dose on Day 1 and 15 of Cycle 1, Day 1 of Cycle 2, 3 and every 2 cycles thereafter (Cycle 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25, 27, 29, 31, 33, 35, 37, 39, 41, 43), End of Treatment (up to maximum duration of 1226 days))
- Half Maximal Effective Concentration (EC50) of Sunitinib(Pre dose on Day 15 of Cycle 1, Day 1 of Cycle 2, 3 and 5 (each cycle 28 days))
- Number of Participants With Increase From Baseline in Corrected QT Interval (QTc)(Baseline up to 1939 days)
- Number of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs) and Serious Adverse Events (SAEs)(Baseline up to 1939 days)
- Number of Participants With Change From Baseline in Physical Examinations Findings(Baseline up to 1939 days)
- Number of Participants With Change From Baseline in Body Weight(Baseline up to 1939 days)
- Number of Participants With Eastern Co-operative Oncology Group Performance Status (ECOG-PS)(Day 1 of Cycle 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, End of treatment (up to maximum duration of 1226 days))
- Dose-Corrected Trough Plasma Concentration of Sunitinib and Its Metabolite SU012662(Pre dose on Day 15 of Cycle 1, Day 1 of Cycle 2, 3 and 5)
- Number of Participants With Adverse Events (AEs) According to Severity(Baseline up to 1939 days)
- Area Under the Curve (AUC24) of Sunitinib and Its Metabolite SU012662(Pre-dose (0 hour) and at multiple time points (up to 24 hours) post dose on Day 15 of Cycle 1, Day 1 of Cycle 2, 3 and 5 (each cycle 28 days))
- Oral Clearance (CL/F) of Sunitinib and Its Metabolite SU012662(Pre dose on Day 15 of Cycle 1, Day 1 of Cycle 2, 3 and 5 (each cycle 28 days))
- Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)(Baseline up to 1939 days)
- Number of Participants With Change From Baseline in Vital Signs Abnormalities(Baseline up to 1939 days)
- Number of Participants With Clinically Significant Laboratory Abnormalities(Baseline up to 1939 days)
研究者
研究点 (26)
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