RONICICLIB / Placebo in Combination With Chemotherapy in Small Cell Lung Cancer

PHASE2TerminatedINTERVENTIONAL
Enrollment

142

Participants

Timeline

Start Date

July 30, 2014

Primary Completion Date

December 31, 2015

Study Completion Date

May 25, 2016

Conditions
Small Cell Lung Carcinoma
Interventions
DRUG

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.

DRUG

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

Trial Locations (32)

1121

Budapest

1200

Bruxelles - Brussel

2045

Törökbálint

3233

Mátraháza

4000

Liège

10043

Turin

13915

Marseille

15232

Pittsburgh

16132

Genoa

17033

Hershey

20900

Monza-Brianza

22927

Großhansdorf

23035

Sondrio

26121

Oldenburg

29285

Brest

29425

Charleston

33486

Boca Raton

34952

Port Saint Lucie

37232

Nashville

45147

Essen

59020

Lille

69126

Heidelberg

75020

Paris

63110-1093

St Louis

830-0011

Kurume

113-8677

Bunkyo

80-952

Gdansk

70-891

Szczecin-Zdunowo

02-781

Warsaw

463-707

Seongnam-si

05505

Seoul

120-752

Seoul

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Bayer

INDUSTRY

NCT02161419 - RONICICLIB / Placebo in Combination With Chemotherapy in Small Cell Lung Cancer | Biotech Hunter | Biotech Hunter