EUCTR2013-000344-25-IT进行中（未招募）1 期
Phase II study of oral PHA-848125AC in patients with malignant thymoma previously treated with multiple lines of chemotherapy
erviano Medical Sciences S.r.l.0 个研究点目标入组 30 人开始时间: 2013年2月27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
- 30
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
- •- Histologically or cytologically proven diagnosis of unresectable B3 thymoma or thymic carcinoma recurrent or progressing after more than one prior systemic therapy for advanced / metastatic disease.
- •Note: Any adjuvant and neoadjuvant systemic therapy followed by the recurrence of the disease within 12 months after the start of the adjuvant treatment will be considered as one therapy for advanced / metastatic disease.
- •- Presence of measurable disease.
- •- Age = 18 years with ECOG performance status 0-1.
- •- Use of effective contraceptive methods if man and women of child producing potential.
- •- Adequate hematologic status: Absolute Neutrophils Count = 1,500 cells/mm3, Platelet Count = 100,000 cells/mm3, 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 metastases are present = 5 ULN).
- •- Adequate renal function: Serum Creatinine = ULN or Creatinine Clearance calculated by Cockcroft and Gault’s formula > 60 mL/min.
- •- 2 weeks or 5 medication half-lives (whichever is longer) must have elapsed since completion of prior systemic therapy and 2 weeks must have elapsed since completion of prior minor surgery and radiotherapy.
- •- Resolution of all acute toxic effects of any prior chemotherapy, surgery or radiotherapy to NCI CTC (Version 3.0) 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 20
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10
排除标准
- •- 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 (with the exception of myasthenia gravis), 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 the patient inappropriate for entry into this study.
研究者
相似试验
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
进行中（未招募）
1 期
PHASE II STUDY OF ORAL PHA-848125AC IN PATIENTS WITH THYMIC CARCINOMA PREVIOUSLY TREATED WITH CHEMOTHERAPY - NDRecurrent or metastatic unresectable thymic carcinomaMedDRA version: 9.1Level: LLTClassification code 10055108MedDRA version: 9.1Level: LLTClassification code 10043674EUCTR2009-014338-79-ITERVIANO MEDICAL SCIENCES72
进行中（未招募）
1 期
A phase I/II study of oral PHA-848125AC given daily for 14 consecutive days every 3 weeks in recurrent malignant gliomaPhase I Part: Recurrent Malignant GliomaPhase II Part: Recurrent Glioblastoma MultiformeMedDRA version: 9.1Level: LLTClassification code 10065443Term: Malignant gliomaMedDRA version: 9.1Level: LLTClassification code 10018337Term: Glioblastoma multiformeEUCTR2006-003193-10-FRerviano Medical Sciences S.r.l.70
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 - NDTreatment of Chronic Myeloid LeukemiaMedDRA version: 9.1Level: LLTClassification code 10009013Term: Chronic myeloid leukaemiaEUCTR2006-006881-40-ITERVIANO MEDICAL SCIENCES16
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