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

• ClinicalTrials.gov Identifier: NCT00376623
• Recruitment Status: Completed
• First Posted: September 15, 2006
• Last Update Posted: May 16, 2014
• Sponsor: Boehringer Ingelheim
• Information provided by: Boehringer Ingelheim

Study Description

Brief Summary:

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 or disease	Intervention/treatment	Phase
Carcinoma, Non-Small-Cell Lung	Drug: BI 2536	Phase 2

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 96 participants
• 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
• Study Start Date: July 2006
• Actual Primary Completion Date: April 2008

Arms and Interventions

Outcome Measures

Primary Outcome Measures :

1. objective tumour response according to RECIST [ Time Frame: every 6 weeks ]

Secondary Outcome Measures :

1. progression free survival [ Time Frame: every 6 weeks ]
2. overall survival [ Time Frame: every 3 weeks ]
3. duration of overall response [ Time Frame: 120 days ]
4. clinical tumour assessment [ Time Frame: 6 weeks ]
5. 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 ]
6. BI 2536 plasma concentrations [ Time Frame: day 1 and day 1-3 in treatment course 1 ]
7. incidence and intensity of adverse events graded according to CTCAE [ Time Frame: every 3 weeks ]
8. incidence of dose limiting toxicity (DLT) incidence of dose limiting toxicity (DLT) [ Time Frame: every 3 weeks ]
9. Number of participants with abnormal laboratory investigations [ Time Frame: every 3 weeks ]
10. Vital signs [ Time Frame: every 3 weeks ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

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

1216.9.49004 Boehringer Ingelheim Investigational Site

Mainz, Germany

1216.9.49005 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

• Responsible Party: Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
• ClinicalTrials.gov Identifier: NCT00376623
• Other Study ID Numbers: 1216.9
• First Posted: September 15, 2006
• Last Update Posted: May 16, 2014
• Last Verified: April 2014

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