CompletedPhase 2NCT00412880

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

StatusCompleted
PhasePhase 2
U.S. locations10
SponsorBoehringer Ingelheim
01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 2
Sponsor
Boehringer Ingelheim
Interventions being studied
Drug: BI 2536
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

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.

04
Study sites

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.

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