NCT00102700已完成2 期
A Phase II Study of ARQ 501 in Combination With Gemcitabine in Adult Patients With Metastatic Pancreatic Adenocarcinoma
ArQule, Inc., a subsidiary of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc. (Rahway, NJ USA)30 个研究点 分布在 1 个国家目标入组 66 人开始时间: 2005年1月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 66
- 试验地点
- 30
- 主要终点
- Document progression free survival after treatment with ARQ 501 and gemcitabine
研究概览
简要总结
The study will document the safety and efficacy of the combination of ARQ 501 and gemcitabine in patients with treatment-naïve, unresectable, metastatic pancreatic adenocarcinoma.
详细描述
This is a single-arm, non-randomized study of ARQ 501 in combination with gemcitabine in adult patients with treatment-naïve, unresectable, metastatic pancreatic adenocarcinoma. The study objectives are:
Primary Objective:
- Assess the overall response rate (ORR) of patients treated with ARQ 501 in combination with gemcitabine.
Secondary Objectives:
- Determine time to tumor progression (TTP) of patients treated with ARQ 501 in combination with gemcitabine
- Further characterize the safety of ARQ 501 in combination with gemcitabine
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
- •Have a pathologically confirmed diagnosis of unresectable, metastatic pancreatic adenocarcinoma
- •Be treatment-naïve.
- •Have measurable disease per RECIST Criteria.
- •Be ≥18 years old.
- •Have a Karnofsky Performance Status (KPS) of ≥70%.
- •Have an estimated life expectancy of ≥12 weeks.
- •Be male or a non-pregnant, non-lactating female patient. Patients who are fertile agree to use an effective barrier method of birth control (e.g., latex condom, diaphragm, or cervical cap) to avoid pregnancy.
- •Have a negative serum or urine pregnancy test within 7 days prior to the first dose of study drug (if patient is a female of childbearing potential).
- •Sign a written informed consent form.
- •Have adequate organ function as indicated by acceptable laboratory values obtained within 7 days prior to the first dose of study drug.
排除标准
- •Have received any prior therapy for the treatment of their pancreatic malignancy (including chemotherapy, immunotherapy, vaccines, monoclonal antibodies, major surgery, or irradiation, whether conventional or investigational).
- •Have an active, uncontrolled systemic infection considered opportunistic, life threatening or clinically significant at the time of treatment.
- •Are pregnant or lactating.
- •Have a psychiatric disorder(s) that would interfere with consent, study participation, or follow-up.
- •Have any other severe concurrent disease, which, in the judgment of the investigator, would make the patient inappropriate for entry into this study.
- •Have symptomatic or untreated central nervous system (CNS) metastases.
- •Have a known hypersensitivity to gemcitabine.
结局指标
主要结局
Document progression free survival after treatment with ARQ 501 and gemcitabine
次要结局
- Document safety and efficacy of ARQ 501 in combination with gemcitabine
研究者
研究点 (30)
Loading locations...
相似试验
已完成
2 期
A Study of ARQ 501 in Patients With Squamous Cell Carcinoma of the Head and NeckHead and Neck NeoplasmsCarcinoma, Squamous CellNCT00358930ArQule, Inc., a subsidiary of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc. (Rahway, NJ USA)60
已完成
1 期
QUILT-2.019: A Study of AMG 655 or AMG 479 in Combination With Gemcitabine for Treatment of Metastatic Pancreatic CancerAdenocarcinoma of the PancreasMetastatic Pancreatic CancerPancreatic CancerNCT00630552NantCell, Inc.138
已完成
1 期
A Study of ARQ 197 in Combination With ErlotinibNon-small-cell Lung CancerNCT01069757Kyowa Kirin Co., Ltd.16
已完成
1 期
A Study of ARQ 197 in Combination With ErlotinibAdvanced/Recurrent Non-small-cell Lung CancerNCT01251796Kyowa Kirin Co., Ltd.9
终止
1 期
Study With Gemcitabine and RTA 402 for Patients With Unresectable Pancreatic CancerPancreatic NeoplasmsPancreatic CancerNCT00529113Biogen33