Status:
COMPLETED
BI 2536 Second Line Monotherapy in SCLC
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Carcinoma, Small Cell
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Open label, uncontrolled Phase II trial to assess the efficacy and safety of BI 2536 in second line treatment in sensitive-relapse SCLC patients.
Eligibility Criteria
Inclusion
- 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
- More than one prior regimen of chemotherapy, mixed small cell/large cell or combined small cell histology.
- Symptomatic brain metastases or leptomeningeal 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
Key Trial Info
Start Date :
February 14 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2008
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT00412880
Start Date
February 14 2007
End Date
June 30 2008
Last Update
June 22 2022
Active Locations (10)
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1
1216.11.007 Boehringer Ingelheim Investigational Site
Fayetteville, Arkansas, United States
2
1216.11.003 Boehringer Ingelheim Investigational Site
Chicago, Illinois, United States
3
1216.11.006 Boehringer Ingelheim Investigational Site
Evanston, Illinois, United States
4
1216.11.002 Boehringer Ingelheim Investigational Site
Boston, Massachusetts, United States