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 (Small Cell Lung Cancer)

PHASE1/PHASE2TerminatedINTERVENTIONAL
Enrollment

43

Participants

Timeline

Start Date

February 25, 2013

Primary Completion Date

March 25, 2016

Study Completion Date

June 23, 2016

Conditions
Small Cell Lung Carcinoma
Interventions
DRUG

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.

DRUG

Etoposide

100 mg/m2 will be administered IV on Days 1, 2, and 3 of each 21 day cycle.

DRUG

Cisplatin

75 mg/m2 will be administered IV on Day 1 of each 21 day cycle after the etoposide infusion is complete.

DRUG

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.

Trial Locations (8)

13005

Marseille

14033

Caen

44195

Cleveland

63110

St Louis

94805

Villejuif

14263-0001

Buffalo

03080

Seoul

03722

Seoul

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Bayer

INDUSTRY