BI 2536 Second Line Monotherapy in SCLC
BI 2536 Second Line Monotherapy in SCLC
Open label, uncontrolled Phase II trial to assess the efficacy and safety of BI 2536 in
 second line treatment in sensitive-relapse SCLC patients.
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 chemotherapy.

 -  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
 drug

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

 -  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