NCT00813384已完成1 期
A Phase 1, First-In-Human Study Evaluating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 208 in Adult Subjects 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
- Amgen
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- To evaluate for clinical responses associated with AMG 208 treatment in subjects (Dose Expansion) with advanced solid malignancies according to RECIST criteria
研究概览
简要总结
First in human, open-label, sequential dose escalation and expansion study of AMG 208 in subjects with advanced solid tumors.
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
- •Men or women ≥ 18 years old
- •Subjects must have a pathologically documented, definitively diagnosed, advanced solid tumor that is refractory to standard treatment, for which no standard therapy is available or the subject refuses standard therapy
- •Measurable disease per RECIST guidelines (subjects with non-measurable, but evaluable disease are also eligible for Part 1 of the study)
- •Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 2
- •Life expectancy of > 3 months, in the opinion of the investigator
- •Female subjects who are post-menopausal (no menstrual period for a minimum of 12 months), or surgically sterilized. Female subjects of child bearing potential must remain abstinent or use double-barrier birth control method during the period of therapy and must be willing to use contraception 2 weeks following the last study drug administration and have a negative serum pregnancy test upon entry into this study
- •Male subject is willing to use contraception upon enrollment, during the course of the study and for 12 weeks following the last study drug administration
- •Willing to provide tumor samples and / or slides
- •Competent to sign and date an Institutional Review Board approved informed consent form
- •Hematological function, as follows:
- •Absolute neutrophil count (ANC) ≥ 1.5 x 109/L Platelet count ≥ 100 x 109/L Hemoglobin > 9 g/dL Prothrombin time (PT) or partial thromboplastin time (PTT) < 1.5 x institutional upper limit of normal (IULN)
- •Renal function, as follows:
- •Serum creatinine < 2.0 mg/dL
- •Hepatic function, as follows:
- •AST/ALT < 3x ULN and total bilirubin < 1.5x ULN in all subjects Alkaline phosphatase < 2.0 x ULN (if liver or bone metastases are present, ≤ 5 x ULN)
排除标准
- •Any disorder that compromises the ability of the subject to give written informed consent and/or to comply with the study procedures.
- •Primary central nervous system (CNS) tumors or metastases
- •History of bleeding diathesis
- •Myocardial infarction within 6 months of study day 1, symptomatic congestive heart failure (New York Heart Association > class II), unstable angina, or unstable cardiac arrhythmia requiring medication, or uncontrolled hypertension in the opinion of the investigator
- •A baseline ECG QTc > 480 ms
- •Active infection within 2 weeks of study enrollment (day 1)
- •Significant gastrointestinal disorder(s), in the opinion of the investigator, (e.g. Crohn's disease, ulcerative colitis, extensive gastrointestinal resection) that may influence drug absorption
- •Known positive test for HIV
- •Known acute or chronic hepatitis B or hepatitis C infection, determined by serologic tests
- •Unresolved toxicities from prior anti-tumor therapy, defined as not having resolved to CTCAE grade 0 or 1, or to levels dictated in the eligibility criteria with the exception of alopecia
- •Anti-tumor therapy (chemotherapy, antibody therapy, molecular targeted therapy, retinoid therapy, hormonal therapy, or investigational agent) within 28 days of study day 1 (six weeks for nitrosureas, mitomycin C, or antibody or molecular targeted agents with t1/2 > 10 days); concurrent use of hormone deprivation therapy for hormone-refractory prostate cancer or breast cancer is permitted
- •Treatment with immune modulators including, but not limited to, systemic corticosteroids, cyclosporine and tacrolimus within two weeks prior to enrollment
- •Therapeutic or palliative radiation therapy within 2 weeks of study day 1
- •Concurrent or prior (within 7 days of study day 1) anticoagulation therapy (low-dose warfarin [≤ 2 mg/day] or low molecular weight heparins for prophylaxis against central venous catheter thrombosis or aspirin [81 mg/day] is allowed)
- •Prior participation in an investigational study and/or procedure within 28 days of study day 1
- •Major surgery within 30 days of study day 1
- •Any co-morbid medical disorder that may increase the risk of toxicity, in the opinion of the investigator or sponsor
研究组 & 干预措施
Dose Escalation
Experimental
The dose escalation part of the study is aimed at determining the maximum tolerated dose (MTD), if feasible, and evaluating the safety, tolerability, pharmacokinetics and pharmacodynamics of AMG 208.
干预措施: AMG 208 (Drug)
Dose Expansion
Experimental
The dose expansion will consist of up to 30 subjects and the dose level of AMG 208 will be dependent upon emerging safety and PK data from the dose escalation part of the study.
干预措施: AMG 208 (Drug)
结局指标
主要结局
To evaluate for clinical responses associated with AMG 208 treatment in subjects (Dose Expansion) with advanced solid malignancies according to RECIST criteria
时间窗: 3.5 years
To characterize the pharmacokinetic (PK) exposure of AMG 208 when administered orally to subjects with advanced solid malignancies
时间窗: 3.5 years
To evaluate the safety and tolerability of AMG 208 in subjects with advanced solid malignancies
时间窗: 3.5 years
To determine the maximum tolerated dose (MTD) of AMG 208, if possible
时间窗: 3.5 years
次要结局
- To evaluate for a decrease in tumor cell proliferation associated with AMG 208 treatment in subjects with advanced solid malignancies according to FLT-PET scanning(3.5 years)
- To assess tumor volume changes after AMG 208 treatment by computed tomography (CT) or magnetic resonance imaging (MRI)(3.5 years)
- To assess skin specimens for potential biomarkers(3.5 years)
- To determine whether c-Met expression, mutation, or amplification in tumor specimens correlates with a response to AMG 208(3.5 years)
研究者
研究点 (1)
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