Phase II Study to Investigate the Efficacy and Safety of ZK 219477 as First Line Therapy in Chemotherapy Naive Patients With Extensive Disease (ED) Stage Small Cell Lung Cancer (SCLC)

Bayer0 sites10 target enrollmentApril 2006

ConditionsSmall Cell Lung Carcinoma

InterventionsSagopilone (BAY86-5302, ZK 219477)

DrugsSagopilone (BAY86-5302, ZK 219477)

Overview

Phase: Phase 2
Intervention: Sagopilone (BAY86-5302, ZK 219477)
Conditions: Small Cell Lung Carcinoma
Sponsor: Bayer
Enrollment: 10
Primary Endpoint: Response to treatment according to the modRECIST (complete response or partial response)
Status: Terminated
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

The purpose of this study is to determine whether the study drug is effective and safe in the first line treatment of patients with 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.

Registry

clinicaltrials.gov

Start Date

April 2006

End Date

April 2007

Last Updated

10 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Bayer

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Histologically or cytologically proven Small-cell lung cancer (SCLC)
•Stage of extensive disease defined by the presence of distant metastases
•At least 1 unidimensionally measureable lesion
•WHO performance status 0 to 1
•No previous SCLC-related chemotherapy
•No previous SCLC-related surgery
•No previous radiotherapy (excepting for brain metastasis)
•Adequate function of major organs and systems
•Nervous system
•No Grade 2 or greater peripheral neuropathy

Exclusion Criteria

•Superior vena cava syndrome or obstruction of any vital structure
•Untreated malignant hypercalcemia
•Pleural effusion as the only manifestation of disease
•Extensive disease amenable to radiation therapy
•Symptomatic brain metastases requiring whole brain irradiation
•Any concomitant malignancy excepting non-melanoma skin cancer or carcinoma in situ of the cervix

Arms & Interventions

Sagopilone

Intervention: Sagopilone (BAY86-5302, ZK 219477)

Outcomes

Primary Outcomes

Response to treatment according to the modRECIST (complete response or partial response)

Time Frame: Every 2 cycles until tumor progression i.e. approximately every 6 weeks

Secondary Outcomes

Duration of complete or partial tumor response(Every 2 cycles until tumor progression i.e. approximately every 6 weeks)
Number of participants with adverse events(Approximately 30 weeks)
Time to tumor progression(Every 2 cycles until tumor progression i.e. approximately every 6 weeks)