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Phase I/II Study to Investigate the Safety, Tolerability, Efficacy and Pharmacokinetics of ZK 219477 in Combination With Cisplatin as First-line Therapy in Chemotherapy-naïve Patients With Extensive-disease (ED) Stage Small-cell Lung Cancer (SCLC)


Phase 2
18 Years
N/A
Not Enrolling
Both
Carcinoma, Small Cell

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Trial Information

Phase I/II Study to Investigate the Safety, Tolerability, Efficacy and Pharmacokinetics of ZK 219477 in Combination With Cisplatin as First-line Therapy in Chemotherapy-naïve Patients With Extensive-disease (ED) Stage Small-cell Lung Cancer (SCLC)


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.


Inclusion Criteria:



- Small-cell lung cancer

- Stage of extensive disease

- Adequate function of major organs and systems

- Use of highly effective birth control methods in females of child-bearing potential

Exclusion Criteria:

- Prior chemotherapy for small-cell lung cancer

- Known allergy or hypersensitivity to platinum-containing drugs

- Pregnant or breast-feeding

- Use of any investigational drug within 4 weeks before start of the study

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Phase 1: Safety measure to establish the MTD or RPDII dose of Sagopilone used in combination with carboplatin and bevacizumab

Outcome Time Frame:

Phase 1: Baseline up to 3 month of treatment

Safety Issue:

Yes

Principal Investigator

Bayer Study Director

Investigator Role:

Study Director

Investigator Affiliation:

Bayer

Authority:

Germany: Federal Institute for Drugs and Medical Devices

Study ID:

91495

NCT ID:

NCT00359359

Start Date:

July 2006

Completion Date:

August 2009

Related Keywords:

  • Carcinoma, Small Cell
  • Small Cell Lung Cancer
  • Carcinoma
  • Lung Neoplasms
  • Small Cell Lung Carcinoma
  • Carcinoma, Small Cell

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