NCT01011439终止2 期
Phase II Study Of Oral PHA-848125AC In Patients With Thymic Carcinoma Previously Treated With 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
- 72
- 试验地点
- 6
- 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 as second-line treatment in patients with recurrent or metastatic, unresectable thymic carcinoma previously treated with chemotherapy.
详细描述
The Simon's optimal 2 stage design is adopted for this single-arm, open-label, multicenter phase II clinical trial of PHA-848125AC administered to patients with recurrent or metastatic, unresectable thymic carcinoma previously treated with chemotherapy (only one prior systemic therapy allowed). The intent of the study is to assess the antitumor activity of PHA-848125AC and ultimately to improve the outcome of patients with thymic carcinoma who have already exploited one chemotherapy option. 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
- •Histologically or cytologically proven diagnosis of unresectable B3 thymoma or thymic carcinoma recurrent or progressing after prior chemotherapy (only one prior systemic therapy allowed)
- •Presence of measurable disease
- •Age >=18 years
- •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, 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 Maleate (PHA-848125AC)
Experimental
100 and 50 mg Capsule 150 mg/day once daily, for 7 consecutive days (days 1 to 7) followed by 7 days of rest (days 8 to 14) in a 2-week cycle
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
- Disease Control Rate(Assessments were made every 6 weeks from start date until PD to a maximum duration of 242 weeks or until PD.)
- Progression-free Survival(Assessments were made every 6 weeks from start date until PD to a maximum duration of 242 weeks or until PD.)
- Confirmed Objective Response Rate (ORR)(Assessments were made every 6 weeks from start date until PD to a maximum duration of 242 weeks or until PD.)
- Duration of Response(Assessments were made every 6 weeks from start date until PD to a maximum duration of 242 weeks or until PD.)
- 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.)
- Overall Safety Profile (Adverse Events (NCI CTCAE) and Hematological and Blood Chemistry Parameters)(Adverse events: from date treatment consent signed to 28 days after last dose of study drug; hematology/blood chemistry tests: at baseline and between Day 11-14 of each cycle of a total of 135 two-week cycles.)
研究者
研究点 (6)
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