43
Participants
Start Date
February 25, 2013
Primary Completion Date
March 25, 2016
Study Completion Date
June 23, 2016
Roniciclib (BAY1000394)
oral administration twice daily in a 3 days on/ 4 days off schedule. Starting dose will be 2.5 mg bid and dose will be escalated or de-escalated depending on dose limiting toxicity.
Etoposide
100 mg/m2 will be administered IV on Days 1, 2, and 3 of each 21 day cycle.
Cisplatin
75 mg/m2 will be administered IV on Day 1 of each 21 day cycle after the etoposide infusion is complete.
Carboplatin
Carboplatin will be administered IV on Day 1 of each 21 day cycle. The dose of carboplatin will be determined for each cycle using the Calvert's formula, to yield an AUC of 5 (mg/mL) • min.
Marseille
Caen
Cleveland
St Louis
Villejuif
Buffalo
Seoul
Seoul
Lead Sponsor
Bayer
INDUSTRY