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Phase Ib / II Study of BAY 1000394 in Combination With Cisplatin / Etoposide or Carboplatin / Etoposide as First-line Therapy in Subjects With Extensive Disease Small Cell Lung Cancer
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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
St Louis, Missouri, United States
Buffalo, New York, United States
Cleveland, Ohio, United States
Caen, France
Marseille, France
Villejuif, France
Seoul, South Korea
Seoul, South Korea
Start Date
February 25, 2013
Primary Completion Date
March 25, 2016
Completion Date
June 23, 2016
Last Updated
April 8, 2021
43
ACTUAL participants
Roniciclib (BAY1000394)
DRUG
Etoposide
DRUG
Cisplatin
DRUG
Carboplatin
DRUG
Lead Sponsor
Bayer
NCT04585750
NCT07046923
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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