Clinical trial NCT00160069: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Carcinoma, Non Small Cell Lung
Keywords: Stage IIIB or stage IV non-small-cell lung cancer.
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2005-09-12
Enrollment: 128
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: 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.
timeFrame: Tumor evaluation (MRI or scan) every 2 cycles until disease progression.
Secondary outcomes:
measure: Secondary objectives : investigate the safety and tolerability of ZK 219477
timeFrame: Continuously
Other outcomes:
Locations:
city: Löwenstein
country: Germany
state: Baden-Württemberg
city: Augsburg
country: Germany
state: Bayern
city: Gauting
country: Germany
state: Bayern
city: Nürnberg
country: Germany
state: Bayern
city: Frankfurt
country: Germany
state: Hessen
city: Frankfurt
country: Germany
state: Hessen
city: Greifswald
country: Germany
state: Mecklenburg-Vorpommern
city: Stralsund
country: Germany
state: Mecklenburg-Vorpommern
city: Halle
country: Germany
state: Sachsen-Anhalt
city: Magdeburg
country: Germany
state: Sachsen-Anhalt
city: Leipzig
country: Germany
state: Sachsen
city: Großhansdorf
country: Germany
state: Schleswig-Holstein
city: Berlin
country: Germany
city: Berlin
country: Germany
city: Bremen
country: Germany
city: Ebensfeld
country: Germany
city: Hamburg
country: Germany
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
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.