BI 2536 Second Line Monotherapy in SCLC

This study has been completed.

Sponsor:

Information provided by:

Boehringer Ingelheim Pharmaceuticals

ClinicalTrials.gov Identifier:

NCT00412880

First received: December 18, 2006

Last updated: October 6, 2009

Last verified: October 2009

History of Changes

Tracking Information

First Received Date ^ICMJE

December 18, 2006

Last Updated Date

October 6, 2009

Start Date ^ICMJE

January 2007

Primary Completion Date

June 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Objective tumor response evaluated according to the RECIST criteria by tumor measurements using standard imaging (CT, MRI) [ Time Frame: 2 months ]

Original Primary Outcome Measures ^ICMJE

Objective tumor response evaluated according to the RECIST criteria by tumor measurements using standard imaging (CT, MRI)

Change History

Complete list of historical versions of study NCT00412880 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Progression-free survival Overall survival Duration of overall response Incidence and intensity of adverse events Safety, PK [ Time Frame: One week ]

Original Secondary Outcome Measures ^ICMJE

Progression-free survival
Overall survival
Duration of overall response
Incidence and intensity of adverse events
Safety, PK

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

BI 2536 Second Line Monotherapy in SCLC

Official Title ^ICMJE

Open Label Phase II Study of BI 2536 BS Monotherapy in Patients With Recurrent Small Cell Lung Cancer

Brief Summary

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

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Intervention Model: Single Group Assignment
Primary Purpose: Treatment

Condition ^ICMJE

Carcinoma, Small Cell

Intervention ^ICMJE

Drug: BI 2536

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

Not Provided

Primary Completion Date

June 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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 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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Canada

Administrative Information

NCT Number ^ICMJE

NCT00412880

Other Study ID Numbers ^ICMJE

1216.11

Has Data Monitoring Committee

Not Provided

Responsible Party

Boehringer Ingelheim, Study Chair, Boehringer Ingelheim

Study Sponsor ^ICMJE

Boehringer Ingelheim Pharmaceuticals

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Chair:

Boehringer Ingelheim

Boehringer Ingelheim Pharmaceuticals

Information Provided By

Boehringer Ingelheim Pharmaceuticals

Verification Date

October 2009

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

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