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

• Conditions: patients with advanced or metastatic non small cell lung cancer (NSCLC) stage IIIB or IV who relapsed after or failed first-line chemotherapy

• Registration Number: EUCTR2005-004005-28-DE
• Lead Sponsor: Boehringer Ingelheim Pharma GmbH & Co. KG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-11-06
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

­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

Exclusion Criteria

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified