EUCTR2005-004005-28-DE进行中（未招募）不适用
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 - BI 2536 in NSCLC stage IIIB & IV
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 90
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
- •1.) male or female patient aged 18 years or older
- •2.) patient with histologically or cytologically confirmed advanced or metastatic NSCLC of stage IIIB or IV
- •3.) patient who has relapsed or failed prior first-line chemotherapy for advanced or metastatic disease
- •4.) patient with at least one tumour lesion 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 greater than or equal to 20 mm with conventional techniques or as greater than or equal to 10 mm with spiral CT scan
- •5.) life expectancy of at least three months
- •6.) Eastern co-operative oncology group (ECOG) performance score of 2 or less
- •7.) patient must have given written informed consent which must be consistent with international conference on harmonisation – good clinical practice (ICH-GCP) and local legislation
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.) hypersensitivity to the trial drug or the excipients
- •2.) persistence of toxicities of prior anti cancer therapies which are deemed to be clinically relevant
- •3.) known secondary malignancy requiring therapy
- •4.) brain metastases which are symptomatic or require therapy
- •5.) absolute neutrophil count less than 1,500/mm3
- •6.) platelet count less than 100,000/mm3
- •7.) haemoglobin less than 9 mg/dl
- •8.) 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
- •9.) bilirubin greater than 1.5 mg/dl (> 26 micromol/l, SI unit equivalent)
- •10.) serum creatinine greater than 2.0 mg/dl
- •11.) 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 limit compliance with trial requirement or which are considered relevant for the evaluation of the efficacy or safety of the trial drug
- •12.) 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)
- •13.) radiotherapy within the past four weeks prior to treatment with the trial drug
- •14.) men or women who are sexually active and unwilling to use a medically acceptable method of contraception during the trial
- •15.) pregnancy or lactation
- •16.) 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)
- •17.) patient unable to comply with the protocol
- •18 ) patients who are considered eligible by the investigator for other second-line chemotherapy, radiotherapy or immunotherapy will not be included in the trial
- •19) patients who have received more than two lines of prior anti-tumour therapy for advanced or metastatic non small cell lung cancer
研究者
相似试验
招募中
2 期
An open, randomised, controlled phase II trial of CellProtect in combination with Isatuximab antibody versus Isatuximab antibody alone as maintenance treatment in patients with Multiple Myeloma undergoing high dose treatment (ISA-HC-NK)Multiple myeloma2024-514527-42-00Karolinska Institutet, Karolinska Institutet62
进行中（未招募）
1 期
An open-label, randomised, Phase II study to investigate the efficacy andsafety of Autologous Lymphoid Effector Cells Specific Against Tumour-Cells(ALECSAT) treatment as an add-on therapy to radiotherapy andtemozolomide (standard of care) in patients with newly diagnosedglioblastoma (malignant primary brain tumor)Glioblastoma multiformeEUCTR2015-004058-17-SECytoVac A/S60
进行中（未招募）
1 期
An open, randomized clinical phase I/II trial to investigate maximum tolerated dose, efficacy, and safety of lenalidomide/low-dose dexamethasone in combination with continuous oral cyclophosphamide compared to lenalidomide/low-dose dexamethasone combined with single cyclophosphamide doses IV in patients with relapsed/refractory multiple myelomaEUCTR2008-003829-16-DEGMIHO - Gesellschaft für medizinische Innovation Hämatologie und Onkologie mbH70
进行中（未招募）
不适用
An open, randomised clinical Phase I/IIa trial to investigate the maximum tolerated dose, efficacy, safety and pharmacokinetics of repeated three-week courses of a single dose i.v. BI 2536 on day 1 in comparison to single doses i.v. BI 2536 on days 1, 2 and 3 in patients over 60 years of age with refractory or relapsed acute myeloid leukaemia -Male or female patients older than 60 years of age with confirmed AML (except for APL) according to the WHO definition who relapsed after or are refractory to prior chemotherapy. Leukocyte count should be = 25,000 /µl (25 x 109/Liter). Patient should be not eligible for intensive treatment options. Patient should have a life expectancy = 2 months and Eastern co-operative oncology group performance score of 2 or less.MedDRA version: 8.1Level: LLTClassification code 10001941Term: AMEUCTR2006-000613-38-ATBoehringer Ingelheim Austria GmbH60
进行中（未招募）
不适用
An open, randomised clinical Phase I/IIa trial to investigate the maximum tolerated dose, efficacy, safety and pharmacokinetics of repeated three-week courses of a single dose i.v. BI 2536 on day 1 in comparison to single doses i.v. BI 2536 on days 1, 2 and 3 in patients over 60 years of age with refractory or relapsed acute myeloid leukaemiaEUCTR2006-000613-38-DEBoehringer Ingelheim Pharma GmbH & Co. KG60