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

Carcinoma, Non Small Cell Lung Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00160069
• Other study ID #: 91374
• Secondary ID: 2005-000586-1930
• Status: Completed
• Phase: Phase 2
• First received: September 8, 2005
• Last updated: December 2, 2014
• Start date: August 2005
• Est. completion date: April 2009

Study information

• Verified date: December 2014
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 128
• Est. completion date: April 2009
• Est. primary completion date: April 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non Small Cell Lung
• Carcinoma, Non-Small-Cell Lung

Intervention

Drug:
• Sagopilone (BAY86-5302, ZK 219477)
16 mg/m2, 3-hour infusion, every 3 weeks
• Sagopilone (BAY86-5302, ZK 219477)
22 mg/m2, 30-min infusion, every 3 weeks
• Sagopilone (BAY86-5302, ZK 219477)
22 mg/m2, 3-hour infusion, every 3 weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

Germany, 

References & Publications (1)

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 sago — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		Tumor evaluation (MRI or scan) every 2 cycles until disease progression.	No
Secondary	Secondary objectives : investigate the safety and tolerability of ZK 219477		Continuously	Yes

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