142
Participants
Start Date
July 30, 2014
Primary Completion Date
December 31, 2015
Study Completion Date
May 25, 2016
Roniciclib (BAY1000394)
Patients will receive roniciclib treatment as a 3 days on / 4 days schedule off with two 2.5 mg tablets twice daily for a total dose of 10.0 mg/day during 6 cycles (21 days each) of chemotherapy with Carboplatin/etoposide or Cisplatin/etoposide and continue thereafter as monotherapy until tumor progression, unacceptable toxicity, death, consent withdrawal, or withdrawal from the study.
Placebo
Patients will receive placebo treatment as a 3 days on / 4 days schedule off with two tablets twice daily during 6 cycles (21 days each) of chemotherapy with Carboplatin/etoposide or Cisplatin/etoposide and continue thereafter as monotherapy until tumor progression, unacceptable toxicity, death, consent withdrawal, or withdrawal from the study
Budapest
Bruxelles - Brussel
Törökbálint
Mátraháza
Liège
Turin
Marseille
Pittsburgh
Genoa
Hershey
Monza-Brianza
Großhansdorf
Sondrio
Oldenburg
Brest
Charleston
Boca Raton
Port Saint Lucie
Nashville
Essen
Lille
Heidelberg
Paris
St Louis
Kurume
Bunkyo
Gdansk
Szczecin-Zdunowo
Warsaw
Seongnam-si
Seoul
Seoul
Lead Sponsor
Bayer
INDUSTRY