NCT02211833已完成1 期
A Phase I Open-label Dose Escalation Study of Intravenous BI 2536 Together With Pemetrexed in Previously Treated Patients With Non-small-cell Lung Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 41
- 主要终点
- Number of patients with adverse events during combination therapy
研究概览
简要总结
Exploratory evaluation of safety, tolerability, pharmacokinetics (PK), maximum tolerated dose (MTD), and efficacy of BI 2536 administered in combination with pemetrexed
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
- •Pathologic or cytologic confirmed diagnosis of NSCLC
- •Recurrent, advanced or metastatic NSCLC that had progressed following 1 prior chemotherapy regimen for advanced disease. Patients could have received prior adjuvant chemotherapy as long as the disease free interval was longer than 1 year.
- •Measurable disease by 1 or more techniques (CT, MRI) according to RECIST criteria
- •Male or female aged 18 years or older
- •Life expectancy of at least 3 months
- •Eastern Cooperative Oncology Group (ECOG) performance score 0-2
- •Written informed consent that was consistent with International Conference on Harmonization (ICH) - Good Clinical Practice (GCP) guidelines
排除标准
- •Treatment with an investigational drug in another clinical study within the 28 days prior to the start of therapy or concomitantly with this study
- •Anti-cancer therapy for NSCLC (except radiotherapy for palliative reasons) within the 28 days prior to Day 1 of treatment period 1 of this trial
- •Any persisting toxicities that were deemed to be clinically significant from the previous therapy
- •Received more than 1 prior chemotherapy regimen for advanced disease (not including prior adjuvant therapy). Patients could have received prior epidermal growth factor receptor tyrosine kinase inhibitors
- •Unwilling or unable to take folic acid and vitamin B12 supplementation
- •Active brain metastases (stable for <28 days, symptomatic, or requiring concurrent steroids). Patients who had received prior whole brain irradiation and whose brain metastases were stable according to the criteria above were not excluded
- •Other active malignancy diagnosed within the past 3 years (other than non-melanomatous skin cancer and cervical intraepithelial neoplasia)
- •Concomitant intercurrent illnesses including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness or social situation that would have limited compliance with trial requirement or which were considered relevant for the evaluation of the efficacy or safety of the trial drug
- •Unable or unwilling to interrupt concomitant administration of NSAIDS 5 days prior to the day of and up to 2 days after the administration of pemetrexed
- •Received prior therapy with pemetrexed
- •Absolute neutrophil count (ANC) ≤1 500/μL, platelet count ≤100 000/μL, or haemoglobin <9 mg/dL
- •Total bilirubin >1.5 mg/dL (26 μmol/L), alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) ≥2.5 x the upper limit of normal (ULN), except in cases of known liver metastasis where a maximum 5 x ULN was acceptable
- •Serum creatinine level >1.5 mg/dL and or creatinine clearance <45 mL/min
- •Sexually active and unwilling to use a medically acceptable method of contraception
- •Pregnancy or breast feeding
- •Known or suspected active alcohol or drug abuse
- •Unable to comply with the protocol
- •Any known hypersensitivity to the trial drugs or their excipients
研究组 & 干预措施
BI 2536 with pemetrexed
Experimental
combination therapy phase may be followed by BI 2536 monotherapy for eligible patients
干预措施: BI 2536 (Drug)
BI 2536 with pemetrexed
Experimental
combination therapy phase may be followed by BI 2536 monotherapy for eligible patients
干预措施: Pemetrexed (Drug)
结局指标
主要结局
Number of patients with adverse events during combination therapy
时间窗: up to 20 weeks
according to common terminology criteria for adverse events (CTCAE) 3.0
Maximum tolerated dose (MTD) of BI 2536 in combination with pemetrexed
时间窗: up to 3 weeks
by occurrence of dose limiting toxicities (DLT)
次要结局
- Duration of objective tumor response after combination therapy(up to 1 year)
- Progression free survival (PFS)(up to 2 years)
- Overall survival(up to 2 years)
- Number of patients with abnormal laboratory findings(up to 20 weeks)
- Change in Eastern Cooperative Oncology Group (ECOG) performance score(baseline, up to 1 year)
- Objective tumor response after combination therapy(up to 20 weeks)
研究者
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