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BI 2536 Second Line Monotherapy in SCLC

Primary Purpose

Carcinoma, Small Cell

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
BI 2536
Sponsored by
Boehringer Ingelheim
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carcinoma, Small Cell

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • 1216.11.007 Boehringer Ingelheim Investigational Site
  • 1216.11.003 Boehringer Ingelheim Investigational Site
  • 1216.11.006 Boehringer Ingelheim Investigational Site
  • 1216.11.002 Boehringer Ingelheim Investigational Site
  • 1216.11.005 Boehringer Ingelheim Investigational Site
  • 1216.11.001 Boehringer Ingelheim Investigational Site
  • 1216.11.011 Boehringer Ingelheim Investigational Site
  • 1216.11.010 Boehringer Ingelheim Investigational Site
  • 1216.11.012 Boehringer Ingelheim Investigational Site
  • 1216.11.009 Alberta Cancer Board

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

BI 2536

Arm Description

Total Patients

Outcomes

Primary Outcome Measures

Number of Participants With Objective Tumor Response
Objective tumor response by investigator was assessed for patients who completed at least two courses of BI 2536 treatment. Tumor images from CT (computed tomography) scan and MRI (magnetic resonance imaging) were evaluated using Response evaluation criteria in solid tumors (RECIST) criteria to determine best tumor response. Objective response (OR) was defined as either: complete response (CR, disappearance of all target lesions) or partial response (PR, at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter).

Secondary Outcome Measures

Progression Free Survival (PFS)
Progression free survival (PFS) was defined as the duration of time from start of treatment to time of progression (or death any cause). Patients who did not experience progression or death during the trial were censored at the date of last tumor assessment visit at which the patient was evaluated and did not experience progressive disease. Patients who dropped out before any evaluation of response, radiological, clinical, or pathological, were censored at the start of treatment. Progressive Disease (PD) was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new lesions.
Overall Survival
Overall survival (OS) was reported as number of participants with event. Overall survival is the time from first treatment to death. In case there was no occurrence of death or progression during follow-up, the time was censored. Median survival time was not calculated due to the low number of deaths in the trial.
Duration of Overall Response
The duration of overall objective response (OR) was measured from the time measurement criteria were met for complete response (CR) or partial response (PR) (whichever was first recorded) until the first date that recurrent or progressive disease was objectively documented (taking as reference for progressive disease the smallest measurements recorded since the treatment started) or death any cause. OR is defined as either: CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter).
Occurrence and Intensity of Adverse Events Graded According to CTCAE
Occurrence and intensity of adverse events graded according to common terminology criteria of adverse event (CTCAE) version 3.0.
Number of Participants With Dose Limiting Toxicity
Number of Participants with Dose Limiting Toxicity. Dose limiting toxicity was defined as: drug related CTCAE Grade 3 or greater non-hematological toxicity (excluding untreated nausea, vomiting or diarrhea) drug related CTCAE Grade 4 neutropenia for 7 or more days or complicated by infection CTCAE Grade 4 thrombocytopenia.
Number of Participants With an Increase in CTC Grade Classification for Hematological and Clinical Chemistry Laboratory Measures
Number of participants with an increase in common terminology criteria (CTC) Grade classification for hematological and clinical chemistry laboratory measures. Changes from Baseline in laboratory measures were classified according to CTC Grades 1-4. Results summarizes the number of patients who had a change in laboratory value that represented an increase in CTC Grade classification during the study (based on maximum Grade).

Full Information

First Posted
December 18, 2006
Last Updated
May 30, 2022
Sponsor
Boehringer Ingelheim
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1. Study Identification

Unique Protocol Identification Number
NCT00412880
Brief Title
BI 2536 Second Line Monotherapy in SCLC
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
February 14, 2007 (Actual)
Primary Completion Date
June 30, 2008 (Actual)
Study Completion Date
June 30, 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boehringer Ingelheim

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carcinoma, Small Cell

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
23 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BI 2536
Arm Type
Experimental
Arm Description
Total Patients
Intervention Type
Drug
Intervention Name(s)
BI 2536
Intervention Description
Intravenous Infusion
Primary Outcome Measure Information:
Title
Number of Participants With Objective Tumor Response
Description
Objective tumor response by investigator was assessed for patients who completed at least two courses of BI 2536 treatment. Tumor images from CT (computed tomography) scan and MRI (magnetic resonance imaging) were evaluated using Response evaluation criteria in solid tumors (RECIST) criteria to determine best tumor response. Objective response (OR) was defined as either: complete response (CR, disappearance of all target lesions) or partial response (PR, at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter).
Time Frame
Scans during screening (day -28 till day 0) and day 1 of every other (even numbered) 21 day treatment cycle. Up to 40 weeks.
Secondary Outcome Measure Information:
Title
Progression Free Survival (PFS)
Description
Progression free survival (PFS) was defined as the duration of time from start of treatment to time of progression (or death any cause). Patients who did not experience progression or death during the trial were censored at the date of last tumor assessment visit at which the patient was evaluated and did not experience progressive disease. Patients who dropped out before any evaluation of response, radiological, clinical, or pathological, were censored at the start of treatment. Progressive Disease (PD) was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new lesions.
Time Frame
Scans during screening (day -28 till day 0) and day 1 of every other (even numbered) 21 day treatment cycle. Up to 40 weeks.
Title
Overall Survival
Description
Overall survival (OS) was reported as number of participants with event. Overall survival is the time from first treatment to death. In case there was no occurrence of death or progression during follow-up, the time was censored. Median survival time was not calculated due to the low number of deaths in the trial.
Time Frame
From the start of treatment till death or discontinuation, up to 36 weeks.
Title
Duration of Overall Response
Description
The duration of overall objective response (OR) was measured from the time measurement criteria were met for complete response (CR) or partial response (PR) (whichever was first recorded) until the first date that recurrent or progressive disease was objectively documented (taking as reference for progressive disease the smallest measurements recorded since the treatment started) or death any cause. OR is defined as either: CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter).
Time Frame
Scans during screening (day -28 till day 0) and day 1 of every other (even numbered) 21 day treatment cycle. Up to 40 weeks.
Title
Occurrence and Intensity of Adverse Events Graded According to CTCAE
Description
Occurrence and intensity of adverse events graded according to common terminology criteria of adverse event (CTCAE) version 3.0.
Time Frame
From the start of treatment till the last infusion + 21 days, up to 36 weeks.
Title
Number of Participants With Dose Limiting Toxicity
Description
Number of Participants with Dose Limiting Toxicity. Dose limiting toxicity was defined as: drug related CTCAE Grade 3 or greater non-hematological toxicity (excluding untreated nausea, vomiting or diarrhea) drug related CTCAE Grade 4 neutropenia for 7 or more days or complicated by infection CTCAE Grade 4 thrombocytopenia.
Time Frame
From the start of treatment till the last treatment + 21 days, up to 36 weeks.
Title
Number of Participants With an Increase in CTC Grade Classification for Hematological and Clinical Chemistry Laboratory Measures
Description
Number of participants with an increase in common terminology criteria (CTC) Grade classification for hematological and clinical chemistry laboratory measures. Changes from Baseline in laboratory measures were classified according to CTC Grades 1-4. Results summarizes the number of patients who had a change in laboratory value that represented an increase in CTC Grade classification during the study (based on maximum Grade).
Time Frame
From the start of treatment till the last treatment + 21 days, up to 36 weeks.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Organizational Affiliation
Boehringer Ingelheim
Official's Role
Study Chair
Facility Information:
Facility Name
1216.11.007 Boehringer Ingelheim Investigational Site
City
Fayetteville
State/Province
Arkansas
Country
United States
Facility Name
1216.11.003 Boehringer Ingelheim Investigational Site
City
Chicago
State/Province
Illinois
Country
United States
Facility Name
1216.11.006 Boehringer Ingelheim Investigational Site
City
Evanston
State/Province
Illinois
Country
United States
Facility Name
1216.11.002 Boehringer Ingelheim Investigational Site
City
Boston
State/Province
Massachusetts
Country
United States
Facility Name
1216.11.005 Boehringer Ingelheim Investigational Site
City
Saint Louis
State/Province
Missouri
Country
United States
Facility Name
1216.11.001 Boehringer Ingelheim Investigational Site
City
Chapel Hill
State/Province
North Carolina
Country
United States
Facility Name
1216.11.011 Boehringer Ingelheim Investigational Site
City
Charleston
State/Province
South Carolina
Country
United States
Facility Name
1216.11.010 Boehringer Ingelheim Investigational Site
City
Greenville
State/Province
South Carolina
Country
United States
Facility Name
1216.11.012 Boehringer Ingelheim Investigational Site
City
Seattle
State/Province
Washington
Country
United States
Facility Name
1216.11.009 Alberta Cancer Board
City
Edmonton
State/Province
Alberta
Country
Canada

12. IPD Sharing Statement

Links:
URL
http://www.mystudywindow.com/
Description
Related Info

Learn more about this trial

BI 2536 Second Line Monotherapy in SCLC

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