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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
Bayer
About
Eligibility
Locations
Arms
Outcomes
Full info

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

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

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

First Posted
September 8, 2005
Last Updated
December 2, 2014
Sponsor
Bayer
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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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Learn more about this trial

Safety and Efficacy Study of a New Chemotherapy Agent to Treat Non-small-cell Lung Cancer

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