Safety and Efficacy Study of a New Chemotherapy Agent to Treat Non-small-cell Lung Cancer
Primary Purpose
Carcinoma, Non Small Cell Lung
Status
Completed
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
Sagopilone (BAY86-5302, ZK 219477)
Sagopilone (BAY86-5302, ZK 219477)
Sagopilone (BAY86-5302, ZK 219477)
Sponsored by
About this trial
This is an interventional treatment trial for Carcinoma, Non Small Cell Lung focused on measuring Stage IIIB or stage IV non-small-cell lung cancer.
Eligibility Criteria
Inclusion Criteria: Non-small-cell lung cancer Only one previous chemotherapy with a platinum-containing drug Use of highly effective birth control methods in females of child-bearing potential Exclusion Criteria: No more than 1 previous chemotherapy for advanced disease Previous participation in another trial within the last 4 weeks Breast feeding Active infections
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Arm 1
Arm 2
Arm 3
Arm Description
Outcomes
Primary Outcome Measures
The primary efficacy variable is defined as Proportion of patients with either CR or PR as 'best overall response'. Tumor assessment is performed according to RECIST criteria.
Secondary Outcome Measures
Secondary objectives : investigate the safety and tolerability of ZK 219477
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00160069
Brief Title
Safety and Efficacy Study of a New Chemotherapy Agent to Treat Non-small-cell Lung Cancer
Official Title
Phase II Study to Investigate the Efficacy and Safety of ZK 219477 as Second Line Therapy in Patients With Stage IIIB or Stage IV Non Small Cell Lung Cancer (NSCLC)
Study Type
Interventional
2. Study Status
Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
August 2005 (undefined)
Primary Completion Date
April 2008 (Actual)
Study Completion Date
April 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bayer
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Phase 2 study to investigate the efficacy and tolerability of epothilone ZK 219477 in patients with stage IIIb or stage IV non-small-cell lung cancer.
Detailed Description
The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer Schering Pharma AG, Germany.Bayer Schering Pharma AG, Germany is the sponsor of the trial.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carcinoma, Non Small Cell Lung
Keywords
Stage IIIB or stage IV non-small-cell lung cancer.
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
128 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm 1
Arm Type
Experimental
Arm Title
Arm 2
Arm Type
Experimental
Arm Title
Arm 3
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Sagopilone (BAY86-5302, ZK 219477)
Intervention Description
16 mg/m2, 3-hour infusion, every 3 weeks
Intervention Type
Drug
Intervention Name(s)
Sagopilone (BAY86-5302, ZK 219477)
Intervention Description
22 mg/m2, 30-min infusion, every 3 weeks
Intervention Type
Drug
Intervention Name(s)
Sagopilone (BAY86-5302, ZK 219477)
Intervention Description
22 mg/m2, 3-hour infusion, every 3 weeks
Primary Outcome Measure Information:
Title
The primary efficacy variable is defined as Proportion of patients with either CR or PR as 'best overall response'. Tumor assessment is performed according to RECIST criteria.
Time Frame
Tumor evaluation (MRI or scan) every 2 cycles until disease progression.
Secondary Outcome Measure Information:
Title
Secondary objectives : investigate the safety and tolerability of ZK 219477
Time Frame
Continuously
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Non-small-cell lung cancer
Only one previous chemotherapy with a platinum-containing drug
Use of highly effective birth control methods in females of child-bearing potential
Exclusion Criteria:
No more than 1 previous chemotherapy for advanced disease
Previous participation in another trial within the last 4 weeks
Breast feeding
Active infections
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bayer Study Director
Organizational Affiliation
Bayer
Official's Role
Study Director
Facility Information:
City
Löwenstein
State/Province
Baden-Württemberg
ZIP/Postal Code
74245
Country
Germany
City
Augsburg
State/Province
Bayern
ZIP/Postal Code
86156
Country
Germany
City
Gauting
State/Province
Bayern
ZIP/Postal Code
82131
Country
Germany
City
Nürnberg
State/Province
Bayern
ZIP/Postal Code
90419
Country
Germany
City
Frankfurt
State/Province
Hessen
ZIP/Postal Code
60590
Country
Germany
City
Frankfurt
State/Province
Hessen
ZIP/Postal Code
65929
Country
Germany
City
Greifswald
State/Province
Mecklenburg-Vorpommern
ZIP/Postal Code
17475
Country
Germany
City
Stralsund
State/Province
Mecklenburg-Vorpommern
ZIP/Postal Code
17475
Country
Germany
City
Halle
State/Province
Sachsen-Anhalt
ZIP/Postal Code
06120
Country
Germany
City
Magdeburg
State/Province
Sachsen-Anhalt
ZIP/Postal Code
39130
Country
Germany
City
Leipzig
State/Province
Sachsen
ZIP/Postal Code
04103
Country
Germany
City
Großhansdorf
State/Province
Schleswig-Holstein
ZIP/Postal Code
22927
Country
Germany
City
Berlin
ZIP/Postal Code
12200
Country
Germany
City
Berlin
ZIP/Postal Code
14165
Country
Germany
City
Bremen
ZIP/Postal Code
29325
Country
Germany
City
Ebensfeld
ZIP/Postal Code
96250
Country
Germany
City
Hamburg
ZIP/Postal Code
21075
Country
Germany
12. IPD Sharing Statement
Citations:
PubMed Identifier
23522488
Citation
Heigener DF, von Pawel J, Eschbach C, Brune A, Schmittel A, Schmelter T, Reck M, Fischer JR. Prospective, multicenter, randomized, independent-group, open-label phase II study to investigate the efficacy and safety of three regimens with two doses of sagopilone as second-line therapy in patients with stage IIIB or IV non-small-cell lung cancer. Lung Cancer. 2013 Jun;80(3):319-25. doi: 10.1016/j.lungcan.2013.02.007. Epub 2013 Mar 20.
Results Reference
result
Links:
URL
http://www.clinicaltrialsregister.eu
Description
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Safety and Efficacy Study of a New Chemotherapy Agent to Treat Non-small-cell Lung Cancer
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