EUCTR2010-020151-31-IT进行中（未招募）1 期
An Extension Protocol for Subjects Who Were Previously Enrolled in Other ARQ 197 Protocols
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- ARQULE
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Signed written informed consent to Study ARQ 197-299 2. Male or female subjects of the age defined in the original protocol they were enrolled. 3. Eastern Cooperative Oncology Group (ECOG) performance status (PS) =3 4. Adequate bone marrow function: - Absolute neutrophil count (ANC) =1.5 x 10 to the 9th/L - Hemoglobin =8.0 g/dL 5. Enrollment within 14 days of the completion of End of Study Visit of the original study 6. Subjects, who participated in previous ARQ 197 studies that have reached their designated end-dates, who did not meet discontinuation criteria in their original study, and who may, in the opinion of the Investigator and the Sponsor, benefit from treatment 7. Women of childbearing potential must have a negative pregnancy test performed within 14 days of the start of study drug. Both men and women enrolled in this study must agree to use adequate birth control measures while on study
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 5
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 5
排除标准
- •1. Known or suspected allergy to ARQ 197 2. Substance abuse, medical, psychological or social conditions that may interfere with the subject’s participation in the study or evaluation of the study results 3. Any condition that is unstable or which could jeopardize the safety of the subject and his/her compliance in the study 4. A serious uncontrolled medical disorder/condition that in the opinion of the Investigator would impair the ability of the subject to receive protocol therapy 5. Requirement to receive other concurrent chemotherapy (excluding combination therapy defined in original protocol), immunotherapy, radiotherapy, or any other investigational drug while on study. Palliative radiotherapy is allowed provided that: - in the opinion of the Investigator, the subject does not have progressive disease - the radiation field does not encompass a target lesion - no more than 10% of the subject’s bone marrow is irradiated E.5 Primary end point(s): This open label extension protocol will provide subjects who participated in previous ARQ197 studies that have reached their designed end-dates and who may have benefited from the treatment with uninterrupted access to the study drug. Avere i requisiti per ricevere altre chemioterapie concorrenti (escluse terapie combinate definite nel protocollo d'origine), immunoterapia, radioterapia, o qualsiasi altro farmaco investigativo durante lo studio. La radioterapia palliativa è permessa, a condizione che: - secondo l'opinione del medico dello studio, il soggetto non abbia avuto una progressione di malattia il campo della radiazione non comprenda una lesione bersaglio non piùdel 10% del midollo osseo del soggetto sia irradiato
研究者
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