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
  Purpose

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.


Condition Intervention Phase
Carcinoma, Non-Small-Cell Lung
Drug: BI 2536
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • objective tumour response according to RECIST [ Time Frame: every 6 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 96
Study Start Date: July 2006
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00376623

Locations
Germany
1216.9.49002 Boehringer Ingelheim Investigational Site
Freiburg, Germany
1216.9.49007 Boehringer Ingelheim Investigational Site
Gauting, Germany
1216.9.49008 Boehringer Ingelheim Investigational Site
Großhansdorf, Germany
1216.9.49001 Boehringer Ingelheim Investigational Site
Heidelberg, Germany
1216.9.49005 Boehringer Ingelheim Investigational Site
Mainz, Germany
1216.9.49004 Boehringer Ingelheim Investigational Site
Mainz, Germany
1216.9.49003 Boehringer Ingelheim Investigational Site
Wiesbaden, Germany
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

No publications provided

Responsible Party: Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00376623     History of Changes
Other Study ID Numbers: 1216.9
Study First Received: September 14, 2006
Last Updated: April 30, 2014
Health Authority: Germany: Bundesinstitut fuer Arzneimittel und Medizinprodukte
United States: Food and Drug Administration

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on September 16, 2014