NCT01301391终止2 期
Phase II Study Of Oral PHA-848125AC In Patients With Malignant Thymoma Previously Treated With Multiple Lines Of Chemotherapy
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 30
- 试验地点
- 3
- 主要终点
- Progression-free Survival Rate at 3 Months
研究概览
简要总结
The intent of the study is to assess the antitumor activity of PHA-848125AC in patients with recurrent or metastatic, unresectable malignant thymoma previously treated with multiple lines of chemotherapy.
详细描述
This is a single-arm, open-label, multicenter, phase II clinical trial design with an early stopping rules. PHA-848125AC will be administered to patients with recurrent metastatic unresectable B3 thymoma or thymic carcinoma who have received more than one line of prior systemic therapy for advanced / metastatic disease. The intent of the study is to assess the antitumor activity of PHA-848125AC and ultimately to improve the outcome of the patients. The primary end point for this study is a progression free survival rate of 3 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed and dated IRB/Approved Informed Consent
- •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
- •Presence of measurable disease
- •Age >=18 years old
- •ECOG performance status 0-1
- •Negative pregnancy test (if female in reproductive years)
- •Use of effective contraceptive methods if men and women of child producing potential
- •Adequate liver function Total Serum Bilirubin <=1.5 x upper limit of normal (ULN) Transaminases (AST/ALT) <=2.5ULN (if liver metastases are present, then <=5ULN is allowed) ALP <=2.5ULN (if liver and/or bone metastases are present, then <=5ULN is allowed)
- •Adequate renal function Serum Creatinine <=ULN or Creatinine Clearance calculated by Cockcroft and Gault's formula > 60 mL/min
- •Adequate hematologic status ANC >=1,500cells/mm3 Platelet Count >= 100,000cells/mm3 Hemoglobin >=9.0g/dL
- •Two 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)
- •Resolution of all acute toxic effects of any prior treatments to NCI CTC (Version 3.0) grade <=1
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
- •Known brain metastases
- •Known active infections
- •Pregnant or breast feeding women
- •Diabetes mellitus uncontrolled
- •Gastrointestinal disease 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
研究组 & 干预措施
Milciclib
Experimental
Milciclib Maleate capsules
干预措施: Milciclib Maleate (Drug)
结局指标
主要结局
Progression-free Survival Rate at 3 Months
时间窗: 3 months since treatment start
The proportion of successes (i.e. patients alive and progression-free at 3 months since treatment start) out of the total number of evaluable patients.
次要结局
- Adverse Events (NCI CTCAE) and Hematological and Blood Chemistry Parameters(Adverse events: from date treatment consent signed to 28 days after last treatment; hematology/blood chemistry tests: at baseline and between Day 11-14 of each cycle of a maximum total of 48 two-week cycles.)
- Objective Response Rate (ORR)(Assessments were made every 6 weeks from start date until PD or up to a maximum duration of 134 weeks.)
- Disease Control Rate (ORR+SD Rate)(Assessments were made every 6 weeks from start date until PD or up to a maximum duration of 134 weeks.)
- Duration of Response(Assessments were made every 6 weeks from start date until PD or up to a maximum duration of 134 weeks.)
- Overall Survival(Every 6 weeks during Follow-Up until PD or new therapy start; every 6 months thereafter, up to 2 years from the last dose of study drug.)
- Progression-free Survival (PFS)(Assessments were made every 6 weeks from start date until PD or up to a maximum duration of 134 weeks.)
研究者
研究点 (3)
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