NCT00915278终止1 期
A Phase 1 Safety, Pharmacokinetic And Pharmacodynamic Study Of The Anti-A5B1 Integrin Monoclonal Antibody PF-04605412 Administered Intravenously To Adult Patients With Advanced Or Metastatic Solid Tumors
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- Pfizer
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- Number of Participants With Dose-limiting Toxicities (DLT)
研究概览
简要总结
Dose finding study of the MoaB PF-04605412 directed against the alpha5beta1 integrin. Main objective is to define the MTD (maximum tolerated dose) or MAD (maximum administrable dose) in cancer patients pre treated or unresponsive to standard therapies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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 or cytologically confirmed advanced measurable or evaluable solid tumors unresponsive to currently available therapies, or for which there is no curative therapy
- •Eastern Cooperative Oncology Group (ECOG) performance status 0 and 1
- •Life expectancy more than12 weeks
- •Adequate bone marrow, liver and renal function
排除标准
- •Known brain metastasis
- •Chemotherapy, radiotherapy, or any investigational cancer therapy within 4 weeks of start of screening procedures
- •Major surgical procedure within 4 weeks of start of screening procedures
- •Active bleeding disorder, including gastrointestinal bleeding, as evidenced by hematemesis, significant hemoptysis or melena in the past 6 months
研究组 & 干预措施
PF-04605412
Experimental
干预措施: PF-04605412 (Drug)
结局指标
主要结局
Number of Participants With Dose-limiting Toxicities (DLT)
时间窗: Baseline up to 6 weeks PF-04605412
DLT was defined as any of the following events occurring during the first 28 days of study medication and considered at least possibly-related to study medication: any grade 3 or 4 clinically-relevant non-hematologic toxicity,any \>= Grade 3 adverse event (AE) graded by National Cancer Institute \[NCI\] Common Terminology Criteria for Adverse Events \[CTCAE\], version 3.0 without a clear alternative explanation to study treatment relationship occurring during the first 6 weeks of treatment with PF-04605412. DLT was used to determine maximum tolerated dose (MTD) in this study.
次要结局
- Serum Decay Half-Life (t1/2)(Predose, 1, 2, 2.5, 3, 6, 10, 24 hours after the start of infusion on Day 1; Days 3, 5, 8, 11, 15, 22 of Cycle 1)
- Maximum Observed Serum Concentration (Cmax)(Predose, 1, 2, 2.5, 3, 6, 10, 24 hours after the start of infusion on Day 1; Days 3, 5, 8, 11, 15, 22 of Cycle 1)
- Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - Inf)](Predose, 1, 2, 2.5, 3, 6, 10, 24 hours after the start of infusion on Day 1; Days 3, 5, 8, 11, 15, 22 of Cycle 1)
- Volume of Distribution at Steady State (Vss)(Predose, 1, 2, 2.5, 3, 6, 10, 24 hours after the start of infusion on Day 1; Days 3, 5, 8, 11, 15, 22 of Cycle 1)
- Number of Participants With Caspase 3 Expression(Predose and postdose)
- Number of Participants With Ki67 Expression(Predose and postdose)
- Systemic Clearance (CL)(Predose, 1, 2, 2.5, 3, 6, 10, 24 hours after the start of infusion on Day 1; Days 3, 5, 8, 11, 15, 22 of Cycle 1)
- Number of Participants Positive for Anti-PF04605412 Antibodies(Baseline up to end of treatment)
- Number of Participants With pFAK Expression(Predose and postdose)
- Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)(Predose, 1, 2, 2.5, 3, 6, 10, 24 hours after the start of infusion on Day 1; Days 3, 5, 8, 11, 15, 22 of Cycle 1)
- Objective Response - Number of Participants With Objective Response(Baseline up to 6 weeks after the first infusion of PF-04605412 (end of Cycle 2) and approximately every 6 weeks thereafter only in the absence of progressive disease)
- Percent Change in Transfer Constant (Ktrans) From Baseline to Cycle 1 Day 15(Screening, and Cycle 1 Day 15)
- Time to Reach Maximum Observed Serum Concentration (Tmax)(Predose, 1, 2, 2.5, 3, 6, 10, 24 hours after the start of infusion on Day 1; Days 3, 5, 8, 11, 15, 22 of Cycle 1)
- Percent Change in Initial Area Under the Curve (IAUC)(Screening, and Cycle 1 Day 15)
- Number of Participants With Tissue Macrophage Infiltration(Predose and postdose)
- Number of Participants With CD56 Expression(Predose and postdose)
- Number of Participants With Integrin Alpha 5 Beta 1 Expression(Predose and postdose)
- Number of Participants With CD68 Expression(Predose and postdose)
- Number of Participants With CD31 Expression(Predose and postdose)
- Number of Participants With Perforin Expression(Predose and postdose)
- Number of Participants With Granzyme B Expression(Predose and postdose)
- Number of Participants With CD16 Expression(Predose and postdose)
研究者
研究点 (1)
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