An Extension Protocol for Subjects Who Were Previously Enrolled in Other ARQ 197 Protocols - N/A

ArQule, Inc.0 个研究点目标入组 10 人开始时间: 2010年10月11日最近更新: 2012年3月19日

适应症

试验速览

暂无简介。

•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
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•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
•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

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