EUCTR2006-006881-40-IT进行中（未招募）不适用
A pilot Phase II study of PHA-739358 in patients with Chronic Myeloid Leukemia relapsing on Gleevec or c-ABL therapy - ND
ERVIANO MEDICAL SCIENCES0 个研究点目标入组 16 人开始时间: 2007年3月13日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 16
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.Patients with CML in chronic, accelerated or blast crisis phases , confirmed by bone marrow biopsy within 14 days of enrollment, relapsing on Gleevec or c-ABL therapy and preferably / 40 with T315I mutation in BCR-ABL kinase 2.Prior chemoimmunotherapy must have been completed 2 weeks before study treatment start. Treatment with hydroxyureas should be discontinued 1 day before initiating dosing with PHA-739358. 3.Age 18 years or greater 4.ECOG performance status of / 2 5.Normal blood pressure / 140/90 mmHg with or without hypertension treatment for at least one week 6.Adequate hepatic and renal function, as defined by serum transaminases / 2.5x ULN, bilirubin / 1.5x ULN, and creatinine / 1.5x ULN Grade 1 7.All acute toxic effects excluding alopecia of any prior therapy must have resolved to NCI CTCAE version 3.0 Grade / 1 8.Personally signed and dated IRB-approved informed consent form indicating that the patient is aware of the neoplastic nature of his/her disease and has been informed of the procedures to be followed, the experimental nature of the therapy, alternatives, potential benefits, side effects, risks, and discomforts 9.Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests and other study procedures
- •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.Major surgeries within 4 weeks from study treatment start or not fully recovered from any previous surgical procedure 2.Presence of central nervous system CNS leukemia 3.Active uncontrolled infection 4.Known history of human immunodeficiency virus HIV infection 5.Grade 3 or 4 bleeding 6.Abnormal LVEF 40 by TTE or 45 by MUGA scan performed within the last 2 weeks 7.Significant cardiovascular disease i.e., uncontrolled arrhythmias, unstable angina , or a major thromboembolic event myocardial infarction, stroke, transient ischemic attack, pulmonary embolism, or non-catheter-related deep-vein thrombosis in the last 6 months 8.Pregnancy or breast-feeding. Female patients must agree to avoid becoming pregnant during the study and in the following 90 days after the end of the treatment, be surgically sterile or be postmenopausal. Male patients must agree to use effective contraception and have no intention to father a child for 180 days after the end of treatment, or be surgically sterile. The definition of effective contraception will be based on the judgment of the principal Investigator or a designated associate 9.Presence of any medical/psychiatric condition or laboratory abnormalities which may limit full compliance with the study, increase the risk associated with study participation or study drug administration, 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
研究者
相似试验
进行中（未招募）
不适用
A Phase II Study of PHA-739358 in Patients with Metastatic Hormone Refractory Prostate Cancer. - NDTreatment of patients with metastatic hormone refractory prostate cancer.MedDRA version: 9.1Level: LLTClassification code 10036909Term: Prostate cancer metastaticEUCTR2006-006136-21-ITERVIANO MEDICAL SCIENCES118
进行中（未招募）
1 期
A Phase II Study of PHA-739358 in Patients with Metastatic Hormone Refractory Prostate Cancer. - not availableMetastatic hormone refractory prostate cancerMedDRA version: 9.1Level: LLTClassification code 10062904Term: Hormone-refractory prostate cancerEUCTR2006-006136-21-FRerviano Medical Sciences S.r.l.118
已完成
2 期
A Phase II Study of PHA-739358 in Patients with Metastatic Hormone Refractory Prostate Cancer.HRPC/ hormone refractory prostate carcinoma10036958NL-OMON31740erviano Medical Sciences Srl, Italy10
进行中（未招募）
不适用
A Phase II Study of PHA-739358 in Patients with Metastatic Hormone Refractory Prostate Cancer. - not availableEUCTR2006-006136-21-NLerviano Medical Sciences S.r.l.118
进行中（未招募）
1 期
Phase II study of oral PHA-848125AC in patients with thymic carcinoma previously treated with chemotherapyRecurrent or metastatic unresectable thymic carcinomaEUCTR2009-014338-79-FRerviano Medical Sciences S.r.l.60