A Phase 2 Study of ARQ 197 in Patients with Microphthalmia Transcription Factor Associated Tumors

ArQule, Inc.0 个研究点目标入组 39 人开始时间: 2009年5月22日最近更新: 2012年3月19日

试验速览

暂无简介。

•Each patient must meet the following criteria to be enrolled in this study:
•1.Provide signed and dated informed consent/assent prior to study-specific screening procedures
•2.Histologically or cytologically confirmed unresectable locally advanced or metastatic alveolar soft part sarcoma, clear cell sarcoma, or translocation associated renal cell carcinoma
•3.=13 years old
•4.Measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST)
•5.Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 (see Appendix 2)
•6.Male or female patients of child-producing potential must agree to use double barrier contraception, oral contraceptives or avoidance of pregnancy measures during the study and for 30 days after the last ARQ 197 dose
•7.Females of childbearing potential must have a negative serum pregnancy test
•8.Aspartate transaminase (AST) and alanine transaminase (ALT) = 2.5 × upper limit of normal (ULN) or = 5 × ULN with metastatic liver disease
•9.Hemoglobin = 8.5 g/dl without transfusion
•10.Total bilirubin = 1.5 × ULN
•11.Serum creatinine = 1.5 x ULN
•12.Absolute neutrophil count (ANC) = 1.5 x 109/L
•13.Platelets = 100 x 109/L without transfusion
•Are the trial subjects under 18? yes
•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

•Patients who meet any of the following criteria will be excluded from the study:
•1.Received anti-cancer therapy including surgery, chemotherapy, radiotherapy and investigational drug within four weeks prior to first dose of ARQ 197
•2.Central nervous system metastasis unless it has been stable for = 3 months after treatment and patient has no neural symptoms
•3.Pregnant or lactating
•4.Significant gastrointestinal disorder(s), in the opinion of a Investigator, could interfere with the absorption of ARQ 197 (e.g., Crohn’s disease, ulcerative colitis, extensive gastric or small bowel resection)
•5.Unable or unwilling to swallow ARQ 197 capsules twice daily
•6.Significant co-morbid conditions that in the opinion of the Investigator would impair study participation
•7.Known human immunodeficiency virus (HIV), Hepatitis B virus (HBV) or hepatitis C virus (HCV) infection
•8.Bradycardia at baseline or known history of arrhythmia
•9.Received ARQ 197 previously

发起方