NCT01152645已完成2 期

Phase II Study of ARQ 197 Monotherapy for Previously Treated Advanced/Recurrent Gastric Cancer

Kyowa Kirin Co., Ltd.0 个研究点目标入组 31 人开始时间: 2010年6月最近更新: 2017年3月15日

研究概览

简要总结

A phase II open-label study with ARQ 197 administered orally and twice daily as monotherapy in patients with previously treated advanced/recurrent gastric cancer. The primary endpoint is disease control and the secondary efficacy endpoints include antitumor effect (tumor response), progression-free survival and overall survival. The pharmacokinetic profile and the safety profile are also evaluated.

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: 20 Years 至 74 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Japanese or Korean with voluntary written informed consent for study participation
•A histologically or cytologically confirmed advanced/recurrent gastric cancer
•One or two prior chemotherapy regimens for advanced/recurrent gastric cancer
•At least one measurable lesion
•ECOG performance status of 0 or 1
•Life expectancy ≥3 months

排除标准

•Surgery for cancer within 4 weeks prior to the first dose of ARQ 197
•Confirmed other tumors than gastric cancer within 5 years prior to the first dose of ARQ 197
•Anticancer chemotherapy, hormone therapy, radiotherapy or immunotherapy within 2 weeks prior to the first dose of ARQ 197
•Positive for HIV antibody
•Known symptomatic brain metastasis
•Gastrointestinal disorders that could interfere with the absorption of ARQ 197 or operation history for gastrointestinal disorders
•Uncontrolled concomitant disease
•Patients who wish to have a child and who would not agree to use contraceptive measures
•Pregnant or lactating

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

Antitumor effect

时间窗: Tumor size was measured at Baseline, Day 29 and 54, and then every 6 week until discontinuation criteria met.

Disease control

次要结局

Overall survival(Survival was confirmed by biweekly inquiry during the study, and by follow up survey.)
Progression-free survival(Tumor size was measured at Baseline, Day 29 and 54, and then every 6 week until discontinuation criteria met. In addition, survival was confirmed by biweekly inquiry during the study, and by follow up survey.)
Pharmacokinetic profile(Plasma sample correction at pre-dose, 1, 2, 4, 6, 10, 12 and 24 hours on Day 1, and in addition, at pre-dose of Day 15 and 29.)
Antitumor effect(Tumor size was measured at Baseline, Day 29 and 54, and then every 6 week until discontinuation criteria met.)
Adverse events(Patients will be monitored for occurrence of adverse events from the day of the first dosing to the completion of the examinations at the discontinuation of the study.)

研究者

发起方

Kyowa Kirin Co., Ltd.

申办方类型

Industry

责任方

Sponsor

相似试验

未知

2 期

Phase II study of ARQ 197 monotherapyAdvanced/recurrent gastric cancer

JPRN-jRCT2080221133Kyowa Hakko Kirin Co., Ltd.

已完成

2 期

Phase 2 Study in Patients With MiT TumorsRenal Cell Carcinoma (RCC)Alveolar Soft Part Sarcoma (ASPS)Clear Cell Sarcoma (CCS)

NCT00557609ArQule, Inc., a subsidiary of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc. (Rahway, NJ USA)47

已完成

1 期

Dose Escalation Study of ARQ 197 in Combination With Gemcitabine in Adult Patients With Advanced Solid TumorsAdvanced Solid Tumors

NCT00874042ArQule, Inc., a subsidiary of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc. (Rahway, NJ USA)74

进行中（未招募）

1 期

A Randomized Controlled Phase 2 Trial of ARQ 197 inPatients with Unresectable Hepatocellular Carcinoma(HCC) Who Have Failed One Prior Systemic Therapynresectable hepatocellular carcinoma (HCC)MedDRA version: 14.0Level: LLTClassification code 10019828Term: Hepatocellular carcinoma non-resectableSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

EUCTR2008-007155-27-BEArQule, Inc.99