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An Open, Randomised Clinical Phase II Trail 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


Phase 2
18 Years
N/A
Not Enrolling
Both
Carcinoma, Non-Small-Cell Lung

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Trial Information

An Open, Randomised Clinical Phase II Trail 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


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Primary Purpose: Treatment

Outcome Measure:

efficacy, objective tumour response, PFS, OS

Outcome Time Frame:

every other treatment course, at time of progression, at death

Principal Investigator

Boehringer Ingelheim

Investigator Role:

Study Chair

Investigator Affiliation:

Boehringer Ingelheim Pharmaceuticals

Authority:

Germany: Bundesinstitut fuer Arzneimittel und Medizinprodukte

Study ID:

1216.9

NCT ID:

NCT00376623

Start Date:

April 2006

Completion Date:

Related Keywords:

  • Carcinoma, Non-Small-Cell Lung
  • Carcinoma
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

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