NCT00376623已完成2 期
An Open, Randomised Clinical Phase II Trial to Investigate the Efficacy, Safety and Pharmacokinetics of a Single Dose of 200 mg of i.v. BI 2536 in Comparison to 50 mg of i.v. BI 2536 Administered on Days 1, 2 and 3 in Patients With Advanced or Metastatic Non Small Cell Lung Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 96
- 试验地点
- 7
- 主要终点
- Objective Tumour Response Evaluated According to the Response Evaluation Criteria in Solid Tumours (RECIST 1.0) by Central Review of the Tumour Images
研究概览
简要总结
The trial will be performed to evaluate whether BI 2536 may be effective in the treatment of advanced or metastatic NSCLC of stage IIIB or IV in patients who relapsed after or failed first-line therapy. A secondary aim is to identify the most suitable dosage schedule for the further Phase II and III clinical programme of BI 2536. To achieve this objective two dosage schedules are compared.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •male or female patients aged 18 years or older with histologically or cytologically confirmed advanced or metastatic NSCLC of stage IIIB or IV, who relapsed or failed prior first-line chemotherapy for advanced or metastatic disease. At least one tumour lesion must be present that can accurately be measured by magnetic resonance imaging (MRI), or computed tomography (CT) in at least one dimension (longest diameter to be recorded) as 20 mm or greater with conventional techniques or as 10 mm or greater with spiral CT scan. Life expectancy of at least three months; Eastern co-operative oncology group (ECOG) performance score of 2 or less and written informed consent which must be consistent with international conference on harmonisation good clinical practice (ICH-GCP) and local legislation
排除标准
- •persistence of toxicities of prior anti cancer therapies which are deemed to be clinically relevant, known secondary malignancy requiring therapy, brain metastases which are symptomatic or require therapy, absolute neutrophil count less than 1,500/mm3, platelet count less than 100,000/mm3, haemoglobin less than 9 mg/dl, aspartate amino transferase (AST) or alanine amino transferase (ALT) greater than 2.5 times the upper limit of normal, or AST or ALT greater than 5 times the upper limit of normal in case of known liver metastases, bilirubin greater than 1.5 mg/dl, serum creatinine greater than 2.0 mg/dl, concomitant intercurrent illnesses that would limit compliance with trial requirement or which are considered relevant for the evaluation of the efficacy or safety of the trial drug, chemo-, hormone- or immunotherapy within the past four weeks or within less than four half-life times of the previous drug prior to treatment with the trial drug (whatever is the longest period), radiotherapy within the past four weeks prior to treatment with the trial drug, men or women who are sexually active and unwilling to use a medically acceptable method of contraception during the trial, pregnancy or lactation, treatment with any other investigational drug within the past four weeks or within less than four half-life times of the investigational drug before treatment with the trial drug (whatever is the longest period), patient unable to comply with the protocol, patients who are considered eligible by the investigator for other second-line chemotherapy, radiotherapy or immunotherapy, patients who have received more than two lines of prior anti-tumour therapy for advanced or metastatic non small cell lung cancer
研究组 & 干预措施
200 milligram (mg) of BI 2536
Experimental
Day 1
干预措施: BI 2536 (Drug)
50 milligram (mg) of BI 2536
Experimental
Day 1, 2, and 3
干预措施: BI 2536 (Drug)
60 milligram (mg) of BI 2536
Experimental
Day 1, 2, and 3
干预措施: BI 2536 (Drug)
结局指标
主要结局
Objective Tumour Response Evaluated According to the Response Evaluation Criteria in Solid Tumours (RECIST 1.0) by Central Review of the Tumour Images
时间窗: assessed at baseline, then every 6 weeks (every second treatment course) until disease progression or start of any other anti-tumour therapy or death or individual participant's end of trial, up to 533 days
The best overall response was the best response recorded from start of treatment until the participant progressed, received any other anti-tumour therapy, died or until the individual participant's end of trial. Number of participants with 'Objective tumour response evaluated according to RECIST 1.0 by central review of the tumour images = Yes' are reported. Objective response is complete response (disappearance of all target lesions) or partial response (at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter). Changes in tumour measurements were confirmed by repeat assessments that had to be performed 6 weeks after the criteria for response had been first met.
次要结局
- Overall Survival(every 6 weeks (every second treatment course), up to 599 days)
- Time-to-deterioration for Symptom Score 'Pain' Assessed on the Composite of Questions 9 and 19 of the European Organization for Research and Treatment Quality of Life (QoL) Questionnaire (EORTC QLQ) C30 Version 3.0(baseline and every 3 weeks (prior to the first administration of BI 2536 in a treatment course comprising 3 weeks), up to 539 days)
- Progression Free Survival(every 6 weeks (every second treatment course), up to 419 days)
- BI 2536 Plasma Concentrations After Intravenous Infusion of 200 Milligram BI 2536 on Day 1 in Treatment Course 1(on day 1 in treatment course 1: 0.5 hour (h) , 1 h, 2 h, 4 h, 120 h post-dose (planned times))
- Duration of Overall Response(assessed at baseline, then every 6 weeks (every second treatment course) until disease progression or start of any other anti-tumour therapy or death or individual participant's end of trial, up to 533 days)
- Objective Tumour Response Evaluated According to the Response Evaluation Criteria in Solid Tumours (RECIST 1.0) by Investigator(assessed at baseline, then every 6 weeks (every second treatment course) until disease progression or start of any other anti-tumour therapy or death or individual participant's end of trial, up to 533 days)
- Time-to-deterioration for Symptom Score 'Cough' Assessed on Question 1 on the Lung Cancer Module QLQ LC13 of the European Organization for Research and Treatment Quality of Life (QoL) Questionnaire (EORTC QLQ) C30 Version 3.0(baseline and every 3 weeks (prior to the first administration of BI 2536 in a treatment course comprising 3 weeks), up to 539 days)
- Time-to-deterioration for Symptom Score 'Dyspnoea' Assessed on the Composite of Questions 3-5 on the Lung Cancer Module QLQ LC13 of the European Organization for Research and Treatment Quality of Life (QoL) Questionnaire (EORTC QLQ) C30 Version 3.0(baseline and every 3 weeks (prior to the first administration of BI 2536 in a treatment course comprising 3 weeks), up to 539 days)
- Incidence of Adverse Events Categorized by Common Terminology Criteria for Adverse Events (CTCAE) Grades(On-treatment period, that is, from first administration of the trial drug until 3 weeks after the last administration of the trial drug, up to 428 days)
- Number of Participants With Thrombocytopenia of Common Terminology Criteria for Adverse Events (CTCAE) Grade 3 or 4(On-treatment period, that is, from first administration of the trial drug until 3 weeks after the last administration of the trial drug, up to 428 days)
- BI 2536 Plasma Concentrations After Intravenous Infusion of 50 / 60 Milligram BI 2536 on Day 1 in Treatment Course 1(on day 1 in treatment course 1: 1 hour (h), 2 h, 23.92 h, 25 h, 47.92 h, 48.5 h, 49 h, 50 h, 52 h, 120 h post-dose (planned times))
- Incidence of Dose Limiting Toxicity (DLT)(On-treatment period, that is, from first administration of the trial drug until 3 weeks after the last administration of the trial drug, up to 428 days)
- Number of Participants With Neutropenia of Common Terminology Criteria for Adverse Events (CTCAE) Grade 3 or 4(On-treatment period, that is, from first administration of the trial drug until 3 weeks after the last administration of the trial drug, up to 428 days)
- Change From Baseline in Systolic/Diastolic Blood Pressure at Individual Participant's End-of-trial Visit(baseline, date of individual participant's end of trial visit which was 533 days after start of treatment at the latest)
- Change From Baseline in Pulse Rate at Individual Participant's End-of-trial Visit(baseline, date of individual participant's end of trial visit which was 533 days after start of treatment at the latest)
研究者
研究点 (7)
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