NCT00302172已完成1 期
A Phase 1 Dose Escalation Study of ARQ 197 in Adult Patients With Metastatic Solid Tumors
ArQule, Inc., a subsidiary of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc. (Rahway, NJ USA)3 个研究点 分布在 1 个国家目标入组 78 人开始时间: 2006年1月最近更新:
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
- 入组人数
- 78
- 试验地点
- 3
- 主要终点
- safety, tolerability
研究概览
简要总结
To determine the safety, tolerability and recommended Phase 2 dose (RP2D) of ARQ 197.
详细描述
To determine the safety, tolerability and recommended Phase 2 dose (RP2D) of ARQ 197 given orally. This is an open label, dose escalation study of ARQ 197 administered orally at a starting dose of 10 mg bid (20 mg/day).
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
- All
- 接受健康志愿者
- 否
入选标准
- •Signed written informed consent must be obtained and documented according to ICH GCP, the local regulatory requirements, and permission to use private health information in accordance with HIPPA prior to study-specific screening procedures
- •A histologically or cytologically confirmed RCC or other c-Met expression tumors that is metastatic
- •Patient must have available archival tumor tissue or accessible tumor that is safely amenable to tumor biopsy
- •≥ 18 years of age
- •Measurable disease as defined by Response Evaluation Criteria in Solid Tumors
- •Karnofsky performance status ≥ 70%
- •Male or female patients of child-producing potential must agree to use contraception or avoidance of pregnancy measures during the study and for 30 days after the last ARQ 197 dose
- •Females of childbearing potential must have a negative serum pregnancy test
- •Aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 2.5 × upper limit of normal (ULN) or ≤ 5.0 × ULN with metastatic liver disease.
- •Hemoglobin (Hgb) ≥ 10 g/dl
- •Total bilirubin ≤ 1.5 × ULN
- •Creatinine ≤ 1.5 x ULN
- •Absolute neutrophil count ≥ 1.5 x 10^9/L
- •Platelets ≥ 100 x 10^9/L
排除标准
- •Anti-cancer chemotherapy, radiotherapy, immunotherapy, or investigational agents within four weeks of first dose
- •Surgery within 4 weeks prior to first dose
- •Known brain metastases
- •Pregnant or breastfeeding
- •Significant gastrointestinal disorder(s), in the opinion of the Principal Investigator, (e.g., Crohn's disease, ulcerative colitis, extensive gastric resection)
- •Unable or unwilling to swallow ARQ 197 capsules twice daily
- •Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, clinically significant non-healing or healing wounds, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, significant pulmonary disease (shortness of breath at rest or mild exertion), uncontrolled infection or psychiatric illness/social situations that would limit compliance with study requirements
- •Bradycardia at baseline or known history of arrhythmia
研究组 & 干预措施
ARQ 197
Experimental
干预措施: ARQ 197 (Drug)
结局指标
主要结局
safety, tolerability
时间窗: All patients will remain on study until progression of disease, unacceptable toxicity, or another discontinuation criterion is met
次要结局
- To determine the pharmacokinetic profile of ARQ 197.(All patients will remain on study until progression of disease, unacceptable toxicity, or another discontinuation criterion is met)
- To determine the pharmacodynamics (i.e., identify biomarkers) of ARQ 197.(All patients will remain on study until progression of disease, unacceptable toxicity, or another discontinuation criterion is met)
- To assess the preliminary anti-tumor activity of ARQ 197.(All patients will remain on study until progression of disease, unacceptable toxicity, or another discontinuation criterion is met)
研究者
研究点 (3)
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