BI 2536 Second Line Monotherapy in SCLC

This study has been completed.
Sponsor:
Information provided by:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00412880
First received: December 18, 2006
Last updated: April 30, 2014
Last verified: April 2014

December 18, 2006
April 30, 2014
January 2007
June 2008   (final data collection date for primary outcome measure)
Objective tumor response evaluated according to the RECIST criteria by tumor measurements using standard imaging (CT, MRI) [ Time Frame: at least 6 weeks ] [ Designated as safety issue: No ]
Objective tumor response evaluated according to the RECIST criteria by tumor measurements using standard imaging (CT, MRI)
Complete list of historical versions of study NCT00412880 on ClinicalTrials.gov Archive Site
  • Progression-free survival [ Time Frame: at least 6 weeks ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: at least 6 weeks ] [ Designated as safety issue: No ]
  • Duration of overall response [ Time Frame: at least 6 weeks ] [ Designated as safety issue: No ]
  • Occurrence and intensity of adverse events graded according to CTCAE [ Time Frame: at least 6 weeks ] [ Designated as safety issue: No ]
  • Occurrence of dose limiting toxicity [ Time Frame: at least 6 weeks ] [ Designated as safety issue: No ]
  • Number of patients with significant abnormalities in laboratory parameters [ Time Frame: 36 weeks ] [ Designated as safety issue: No ]
  • Progression-free survival
  • Overall survival
  • Duration of overall response
  • Incidence and intensity of adverse events
  • Safety, PK
Not Provided
Not Provided
 
BI 2536 Second Line Monotherapy in SCLC
An Open-label Phase II Trial to Investigate the Efficacy, Safety, and Pharmacokinetics of a Single Dose of 200 mg i.v. BI 2536 Administered Every 21 Days in Patients With Sensitive Relapse Small Cell Lung Cancer

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

Not Provided
Interventional
Phase 2
Intervention Model: Single Group Assignment
Primary Purpose: Treatment
Carcinoma, Small Cell
Drug: BI 2536
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
23
Not Provided
June 2008   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada
 
NCT00412880
1216.11
Not Provided
Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
Boehringer Ingelheim
Not Provided
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
Boehringer Ingelheim
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP