NCT00557505已完成1 期
A Phase 1 Pharmacokinetic And Pharmacodynamic Study Of PF-03732010 In Patients With Advanced Solid Tumors
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
- 43
- 试验地点
- 1
- 主要终点
- Maximum Tolerated Dose (MTD)
研究概览
简要总结
P-cadherin may play a part in tumor growth; PF-03732010 is a new drug that inhibits P-cadherin. This study will test how well the drug is tolerated, and what effects there might be. Blood will also be taken to measure the amount of drug in blood.
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
- •Advanced solid tumors refractory to (or intolerant of) established therapy known to provide clinical benefit, or for which there is no standard therapy
- •Age >= 18 years of age
- •Adequate bone marrow function as defined by: absolute neutrophil count (ANC) ≥1500/uL, hemoglobin ≥ 9 g/dL, platelets > 100,000/uL
- •Adequate liver function as defined by: bilirubin < 1.5 x ULN, AST, ALT and ALP < 2.5 x ULN, or < 5 x ULN with documented liver and/or bone metastases
- •Serum creatinine < 1.5 x ULN
- •ECOG status 0-1
- •Availability of biopsy tumor tissue (or fine needle aspirate) for testing of P-cadherin expression
- •Tumor tissue (or fine needle aspirate) showing over-expression of P-cadherin
- •Must be able to give written informed consent
- •Be able to comply with scheduled study visits, treatment plans, laboratory tests and other procedures
排除标准
- •Chemotherapy, radiotherapy, or any investigational cancer therapy within 4 weeks of study entry
- •Patients with carcinomatous meningitis or untreated brain metastases.
- •History of significant low platelet count, and/or bleeding disorders, requiring medical or surgical intervention
- •History of significant bleeding episodes within 6 months, unless the source of bleeding has been resected
研究组 & 干预措施
PF-03732010
Experimental
Single Arm study
干预措施: PF-03732010 (Drug)
结局指标
主要结局
Maximum Tolerated Dose (MTD)
时间窗: Baseline up to end of treatment (EOT) or withdrawal assessed up to Day 7 of last cycle
Recommended Phase-2 Dose (RP2D)
时间窗: Baseline up to EOT or withdrawal assessed up to Day 7 of last cycle
次要结局
- Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-28 Day)](0 (pre-dose), 0.5, 1, 1.5, 2, 5, 10, 24 hrs after the start of infusion of first dose, Day 3, 5, 8, 11 of cycle 1; pre-dose and 1 hr after start of infusion in every other cycle starting from cycle 2 up to Week 4, 8 and 12 after last dose or withdrawal)
- Time to Reach Maximum Observed Serum Concentration (Tmax)(0 (pre-dose), 0.5, 1, 1.5, 2, 5, 10, 24 hrs after the start of infusion of first dose, Day 3, 5, 8, 11 of cycle 1; pre-dose and 1 hr after start of infusion in every other cycle starting from cycle 2 up to Week 4, 8 and 12 after last dose or withdrawal)
- Minimum Observed Serum Trough Concentration (Cmin)(0 (pre-dose), 0.5, 1, 1.5, 2, 5, 10, 24 hrs after the start of infusion of first dose, Day 3, 5, 8, 11 of cycle 1; pre-dose and 1 hr after start of infusion in every other cycle starting from cycle 2 up to Week 4, 8 and 12 after last dose or withdrawal)
- Maximum Observed Serum Concentration (Cmax)(0 (pre-dose), 0.5, 1, 1.5, 2, 5, 10, 24 hrs after the start of infusion of first dose, Day 3, 5, 8, 11 of cycle 1; pre-dose and 1 hr after start of infusion in every other cycle starting from cycle 2 up to Week 4, 8 and 12 after last dose or withdrawal)
- Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-14 Day)](0 (pre-dose), 0.5, 1, 1.5, 2, 5, 10, 24 hrs after the start of infusion of first dose, Day 3, 5, 8, 11 of cycle 1; pre-dose and 1 hr after start of infusion in every other cycle starting from cycle 2 up to Week 4, 8 and 12 after last dose or withdrawal)
- Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)(0 (pre-dose), 0.5, 1, 1.5, 2, 5, 10, 24 hrs after the start of infusion of first dose, Day 3, 5, 8, 11 of cycle 1; pre-dose and 1 hr after start of infusion in every other cycle starting from cycle 2 up to Week 4, 8 and 12 after last dose or withdrawal)
- Clearance (CL)(0 (pre-dose), 0.5, 1, 1.5, 2, 5, 10, 24 hrs after the start of infusion of first dose, Day 3, 5, 8, 11 of cycle 1; pre-dose and 1 hr after start of infusion in every other cycle starting from cycle 2 up to Week 4, 8 and 12 after last dose or withdrawal)
- Apparent Volume of Distribution (Vd)(0 (pre-dose), 0.5, 1, 1.5, 2, 5, 10, 24 hrs after the start of infusion of first dose, Day 3, 5, 8, 11 of cycle 1; pre-dose and 1 hr after start of infusion in every other cycle starting from cycle 2 up to Week 4, 8 and 12 after last dose or withdrawal)
- Number of Participants With Objective Response of Complete Response or Partial Response(Baseline to disease progression or 4 weeks after the first dose and then every 6 weeks up to Week 37)
研究者
研究点 (1)
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