Phase II study of oral PHA-848125AC in patients with thymic carcinoma previously treated with chemotherapy

erviano Medical Sciences S.r.l.0 个研究点目标入组 60 人开始时间: 2009年11月9日最近更新: 2019年2月28日

适应症

试验速览

暂无简介。

•- Histologically or cytologically proven diagnosis of unresectable thymic carcinoma recurrent or progressing after prior chemotherapy (only one prior systemic therapy allowed).
•- Presence of measurable disease
•- Age = 18 years with ECOG performance status 0-1
•- Use of effective contraceptive methods if men and women of child producing potential
•- Adequate hematologic status: Absolute neutrophils count =1,500 cells/mm3, platelet count =100,000 cells/mm3 and hemoglobin =9.0 g/dL.
•- Adequate liver function: Total Serum Bilirubin=1.5 x upper limit of normal (ULN), Transaminases (AST/ALT) = 2.5 ULN (if liver metastases are present = 5 ULN), ALP = 2.5 ULN (if liver and/or bone marrow metastases are present = 5 ULN)
•- Adequate renal function: Serum Creatinine = ULN
•- 2 weeks must have elapsed since completion of prior chemotherapy
•- Resolution of all acute toxic effects of any prior treatments to NCI CTC (Version 3) grade =1
•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

•- Any of the following in the past 6 months: myocardial infarction, uncontrolled cardiac arrhythmia, unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack, pulmonary embolism, deep vein thrombosis.
•- Grade >1 retinopathy as determined by an ophthalmologist
•- Known brain metastases.
•- Known active infections
•- Pregnant or breast feeding women.
•- Diabetes mellitus uncontrolled.
•- Gastrointestinal disease (e.g. Crohn’s disease, ulcerative colitis, or short gut syndrome) that would impact on drug absorption.
•- Patients under treatment with anticoagulants or with coagulation disorders or with signs of hemorrhage at baseline.
•- Patients with previous history or current presence of neurological disorders, including epilepsy (although controlled by anticonvulsant therapy), Parkinson’s disease and extra-pyramidal syndromes.
•- Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that make patients inappropriate for entry into this study

发起方

erviano Medical Sciences S.r.l.