BI 2536 Second Line Monotherapy in SCLC

Completed · Phase 2

Conditions studied: Carcinoma, Small Cell

In brief

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

Key facts

Study ID

NCT00412880

Run by

Boehringer Ingelheim

People needed

23

Starts

2007-02-14

Expected to finish

2008-06-30

Last updated by the study team

2022-06-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• 1216.11.007 Boehringer Ingelheim Investigational Site — Fayetteville, Arkansas, United States
• 1216.11.003 Boehringer Ingelheim Investigational Site — Chicago, Illinois, United States
• 1216.11.006 Boehringer Ingelheim Investigational Site — Evanston, Illinois, United States
• 1216.11.002 Boehringer Ingelheim Investigational Site — Boston, Massachusetts, United States
• 1216.11.005 Boehringer Ingelheim Investigational Site — St Louis, Missouri, United States
• 1216.11.001 Boehringer Ingelheim Investigational Site — Chapel Hill, North Carolina, United States
• 1216.11.011 Boehringer Ingelheim Investigational Site — Charleston, South Carolina, United States
• 1216.11.010 Boehringer Ingelheim Investigational Site — Greenville, South Carolina, United States
• 1216.11.012 Boehringer Ingelheim Investigational Site — Seattle, Washington, United States
• 1216.11.009 Alberta Cancer Board — Edmonton, Alberta, Canada

Full record on ClinicalTrials.gov

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