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

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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)

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)

Trial contacts and locations

17

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Data sourced from clinicaltrials.gov

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