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
  Purpose

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


Condition Intervention Phase
Carcinoma, Small Cell
Drug: BI 2536
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 23
Study Start Date: January 2007
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00412880

Locations
United States, Arkansas
1216.11.007 Boehringer Ingelheim Investigational Site
Fayetteville, Arkansas, United States
United States, Illinois
1216.11.003 Boehringer Ingelheim Investigational Site
Chicago, Illinois, United States
1216.11.006 Boehringer Ingelheim Investigational Site
Evanston, Illinois, United States
United States, Massachusetts
1216.11.002 Boehringer Ingelheim Investigational Site
Boston, Massachusetts, United States
United States, Missouri
1216.11.005 Boehringer Ingelheim Investigational Site
St. Louis, Missouri, United States
United States, North Carolina
1216.11.001 Boehringer Ingelheim Investigational Site
Chapel Hill, North Carolina, United States
United States, South Carolina
1216.11.011 Boehringer Ingelheim Investigational Site
Charleston, South Carolina, United States
1216.11.010 Boehringer Ingelheim Investigational Site
Greenville, South Carolina, United States
United States, Washington
1216.11.012 Boehringer Ingelheim Investigational Site
Seattle, Washington, United States
Canada, Alberta
1216.11.009 Alberta Cancer Board
Edmonton, Alberta, Canada
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

No publications provided

Responsible Party: Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00412880     History of Changes
Other Study ID Numbers: 1216.11
Study First Received: December 18, 2006
Last Updated: April 30, 2014
Health Authority: Canada: Health Canada, Therapeutic Products Directorate
United States: Food and Drug Administration

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Small Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms

ClinicalTrials.gov processed this record on August 28, 2014