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

Bayer

Status and phase: Completed; Phase 2

Conditions: Carcinoma, Non Small Cell Lung

Treatments: Drug: Sagopilone (BAY86-5302, ZK 219477)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00160069

2005-000586-19 (EudraCT Number)

91374

307971 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 128 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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128 participants in 3 patient groups

Arm 1

Experimental group

Treatment:

Drug: Sagopilone (BAY86-5302, ZK 219477)

Drug: Sagopilone (BAY86-5302, ZK 219477)

Drug: Sagopilone (BAY86-5302, ZK 219477)

Arm 2

Experimental group

Treatment:

Drug: Sagopilone (BAY86-5302, ZK 219477)

Drug: Sagopilone (BAY86-5302, ZK 219477)

Drug: Sagopilone (BAY86-5302, ZK 219477)

Arm 3

Experimental group

Treatment:

Drug: Sagopilone (BAY86-5302, ZK 219477)

Drug: Sagopilone (BAY86-5302, ZK 219477)

Drug: Sagopilone (BAY86-5302, ZK 219477)