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Open Label Phase II Study of BI 2536 BS Monotherapy in Patients With Recurrent Small Cell Lung Cancer

Phase 2
18 Years
Not Enrolling
Carcinoma, Small Cell

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Trial Information

Open Label Phase II Study of BI 2536 BS Monotherapy in Patients With Recurrent Small Cell Lung Cancer

Inclusion Criteria:

Inclusion Criteria:

- Patients with histologically or cytologically confirmed, -sensitive-relapse- SCLC
defined by a relapse 60 days or more after cessation of prior first-line

- Patients with at least one measurable lesion, with longest diameter to be recorded as
20 mm or greater.

- Life expectancy of at least three months and ECOG performance score of 2 or less and
written informed consent that must be consistent with ICH-GCP Guidelines.

Exclusion Criteria:

Exclusion Criteria:

- More than one prior regimen of chemotherapy, mixed small cell/large cell or combined
small cell histology.

- Symptomatic brain metastases or leptomenigeal disease

- Patients with ascites, patients who have any other life-threatening illness or organ
system dysfunction, or other malignancies diagnosed within the past five (5) years
(other than non melanomatous skin cancer)

- Absolute neutrophil count (ANC) <1,500/µl, platelet count <100,000/µl, or hemoglobin
<9 mg/dl

- Total bilirubin >1.5 x ULN, aspartame amino transferase (AST) and/or alanine amino
transferase (ALT) >2.5 x ULN, or aspartate amino transferase (AST) and/or alanine
amino transferase (ALT) >5 x ULN in case of known liver metastases, serum creatinine
>2.0 mg/dl (>176 µmol/L, SI Unit equivalent)

- Chemo-, hormone- (other than Megace®) or immunotherapy within the past 4 weeks or
within less than 4 half-life times of the previous drug prior to treatment with the
trial drug

- Radiation therapy within the past 2 weeks prior to or during treatment with the trial

- Patients with any serious active infection (i.e., requiring an IV antibiotic,
antifungal, or antiviral agents), patients with known HIV, hepatitis-B or -C

- Known or suspected active drug or alcohol abuse

- Treatment with any other investigational drug within the past 4 weeks or within less
than 4 half-life times of the investigational drug

- Patients with a known pre-existing coagulopathy or requiring therapeutic
anticoagulation with warfarin (Coumadin ®)

- Patients with neuropathy (sensory or motor) CTCAE 3

Type of Study:


Study Design:

Intervention Model: Single Group Assignment, Primary Purpose: Treatment

Outcome Measure:

Objective tumor response evaluated according to the RECIST criteria by tumor measurements using standard imaging (CT, MRI)

Outcome Time Frame:

2 months

Principal Investigator

Boehringer Ingelheim

Investigator Role:

Study Chair

Investigator Affiliation:

Boehringer Ingelheim Pharmaceuticals


Canada: Health Canada, Therapeutic Products Directorate

Study ID:




Start Date:

January 2007

Completion Date:

Related Keywords:

  • Carcinoma, Small Cell
  • Carcinoma
  • Carcinoma, Small Cell



1216.11.007 Boehringer Ingelheim Investigational Site Fayetteville, Arkansas  
1216.11.003 Boehringer Ingelheim Investigational Site Chicago, Illinois  
1216.11.006 Boehringer Ingelheim Investigational Site Evanston, Illinois  
1216.11.002 Boehringer Ingelheim Investigational Site Boston, Massachusetts  
1216.11.005 Boehringer Ingelheim Investigational Site St. Louis, Missouri  
1216.11.001 Boehringer Ingelheim Investigational Site Chapel Hill, North Carolina  
1216.11.011 Boehringer Ingelheim Investigational Site Charleston, South Carolina  
1216.11.010 Boehringer Ingelheim Investigational Site Greenville, South Carolina  
1216.11.012 Boehringer Ingelheim Investigational Site Seattle, Washington