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.
Checked against the public recordLast updated Jun 22, 2022 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 2
- Sponsor
- Boehringer Ingelheim
- Interventions being studied
- Drug: BI 2536
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
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: * 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
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- 1216.11.007 Boehringer Ingelheim Investigational SiteFayetteville, Arkansas
- 1216.11.003 Boehringer Ingelheim Investigational SiteChicago, Illinois
- 1216.11.006 Boehringer Ingelheim Investigational SiteEvanston, Illinois
- 1216.11.002 Boehringer Ingelheim Investigational SiteBoston, Massachusetts
- 1216.11.005 Boehringer Ingelheim Investigational SiteSt Louis, Missouri
- 1216.11.001 Boehringer Ingelheim Investigational SiteChapel Hill, North Carolina
- 1216.11.011 Boehringer Ingelheim Investigational SiteCharleston, South Carolina
- 1216.11.010 Boehringer Ingelheim Investigational SiteGreenville, South Carolina
- 1216.11.012 Boehringer Ingelheim Investigational SiteSeattle, Washington
- 1216.11.009 Alberta Cancer BoardEdmonton, Alberta
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jun 22, 2022. Always confirm current availability with the study team.