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Clinical Study to Evaluate the Maximum Tolerated Dose of BAY1000394 When Given Together With Chemotherapy and the Effectiveness of This Combination Treatment in Shrinking a Specific Type of Lung Tumors (Smal Cell Lung Cancer)

2014-09-25 15:08:23 | BioPortfolio

Summary

This is the first study where BAY1000394 is given in combination with chemotherapy: cisplatin / etoposide or carboplatin / etoposide. Patients with small cell lung cancer will be treated. Every patient will receive drug treatment, there is no placebo group. Different groups of patients will receive different dosages of BAY1000394 to determine the safety and maximum tolerated dose (MTD) of BAY1000394 in combination with chemotherapy. The dose of chemotherapy is the standard dose usually administered and will not change.

The study will also assess how the drug is metabolized by the body and changes in tumor size.

BAY1000394 will be given per mouth, twice a day for three days every week. Treatment will stop if the tumor continues to grow, if side effects occur which the patient can not tolerate or if the patients decides to exit treatment.

Study Design

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

Conditions

Small Cell Lung Carcinoma

Intervention

Roniciclib (BAY 1000394), Etoposide, Cisplatin, Carboplatin

Location

St. Louis
Missouri
United States
63110

Status

Recruiting

Source

Bayer

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-09-25T15:08:23-0400

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