EUCTR2009-014338-79-IT进行中（未招募）1 期
PHASE II STUDY OF ORAL PHA-848125AC IN PATIENTS WITH THYMIC CARCINOMA PREVIOUSLY TREATED WITH CHEMOTHERAPY - ND
ERVIANO MEDICAL SCIENCES0 个研究点目标入组 72 人开始时间: 2009年12月22日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 72
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 and dated IRB/IEC-approved Informed Consent. 2. Histologically or cytologically proven diagnosis of unresectable thymic carcinoma recurrent or progressing after prior chemotherapy (only one prior systemic therapy allowed). 3. Presence of measurable disease 4. Age >/= 18 years. 5. ECOG performance status 0-1. 6. Estimated life expectancy of at least 3 months. 7. Negative pregnancy test (if female in reproductive years). 8. Agreement upon the use of effective contraceptive methods (hormonal or barrier method of birth control, or abstinence) prior to study entry and for the duration of study participation, if men and women of child producing potential. 9. Adequate liver function: Total Serum Bilirubin /= 1,500 cells/mm3 Platelet Count >/= 100,000 cells/mm3 Hemoglobin >/= 9.0 g/dL. 12. At the time of start of treatment, at least 2 weeks must have elapsed since completion of prior chemotherapy, minor surgery, radiotherapy (provided that no more than 25% of bone marrow reserve has been irradiated). 13. With the exception of alopecia, resolution of all acute toxic effects of any prior chemotherapy, surgery or radiotherapy to NCI CTC (Version 3.0) grade 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
排除标准
- •1. 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. 2. Grade >1 retinopathy as determined by an ophthalmologist. 3. Known brain metastases. 4. Major surgery, other than diagnostic surgery, within 4 weeks prior to treatment. 5. Active, uncontrolled bacterial, viral, or fungal infections. 6. Known infection with HIV, active hepatitis B or hepatitis C. 7. Pregnant or breast feeding women. 8. Previous (within the last 5 years) or current malignancies at other sites, except for adequately treated basal cell or squamous cell skin cancer or in situ carcinoma of the cervix uteri. 9. Current enrollment in or participation in another therapeutic clinical trial within 4 weeks preceding treatment start. 10. Diabetes mellitus uncontrolled. 11. Gastrointestinal disease (e.g. Crohn s disease, ulcerative colitis, or short gut syndrome) that would impact on drug absorption. 12. Patients under treatment with anticoagulants or with coagulation disorders or with signs of hemorrhage at baseline. 13. Patients with previous history or current presence of neurological disorders, including epilepsy (although controlled by anticonvulsant therapy), Parkinson s disease and extra-pyramidal syndromes. 14. Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or may interfere with the interpretation of study results and, in the judgment of the Investigator, would make the patient inappropriate for entry into this study or could compromise protocol objectives in the opinion of the Investigator and/or the Sponsor.
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