Efficacy and Safety of BI 2536 in Advanced or Metastatic Non Small Cell Lung Cancer

This study has been completed.
Sponsor:
Information provided by:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00376623
First received: September 14, 2006
Last updated: April 30, 2014
Last verified: April 2014

September 14, 2006
April 30, 2014
July 2006
April 2008   (final data collection date for primary outcome measure)
objective tumour response according to RECIST [ Time Frame: every 6 weeks ] [ Designated as safety issue: No ]
objective response
Complete list of historical versions of study NCT00376623 on ClinicalTrials.gov Archive Site
  • progression free survival [ Time Frame: every 6 weeks ] [ Designated as safety issue: No ]
  • overall survival [ Time Frame: every 3 weeks ] [ Designated as safety issue: No ]
  • duration of overall response [ Time Frame: 120 days ] [ Designated as safety issue: No ]
  • clinical tumour assessment [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • quality of life assessment (EORTC QLQ-C30 and EORTC QLQ-LC13) quality of life assessment (EORTC QLQ-C30 and EORTC QLQ-LC13) [ Time Frame: every 6 weeks ] [ Designated as safety issue: No ]
  • BI 2536 plasma concentrations [ Time Frame: day 1 and day 1-3 in treatment course 1 ] [ Designated as safety issue: No ]
  • incidence and intensity of adverse events graded according to CTCAE [ Time Frame: every 3 weeks ] [ Designated as safety issue: No ]
  • incidence of dose limiting toxicity (DLT) incidence of dose limiting toxicity (DLT) [ Time Frame: every 3 weeks ] [ Designated as safety issue: No ]
  • Number of participants with abnormal laboratory investigations [ Time Frame: every 3 weeks ] [ Designated as safety issue: No ]
  • Vital signs [ Time Frame: every 3 weeks ] [ Designated as safety issue: No ]
progression free survival, overall survival, duration of overall response, clinical tumour assessment, quality of life assessment, BI 2536 plasma concentrations, incidence and intensity of adverse events graded according to CTCAE
Not Provided
Not Provided
 
Efficacy and Safety of BI 2536 in Advanced or Metastatic Non Small Cell Lung Cancer
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

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.

Not Provided
Interventional
Phase 2
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Carcinoma, Non-Small-Cell Lung
Drug: BI 2536
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
96
Not Provided
April 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

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

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00376623
1216.9
Not Provided
Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
Boehringer Ingelheim
Not Provided
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
Boehringer Ingelheim
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP