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

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.

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Key information

Conditions

Carcinoma, Non Small Cell Lung Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Löwenstein, Baden-Wurttemberg, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sagopilone (BAY86-5302, ZK 219477)

Drug

16 mg/m2, 3-hour infusion, every 3 weeks

Primary outcomes

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 outcomes

Secondary objectives : investigate the safety and tolerability of ZK 219477

Time frame: Continuously

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study 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)

Important dates

Study start: 2005
Primary completion: 2008
Study completion: 2009
First posted: Sep 12, 2005
Registry last updated: Dec 4, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed