(BAY 1000394/14858) 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
Description: 

(Phase Ib Part) Determine the safety, tolerablility, pharmacokinetics and maximum tolerated dose of BAY 1000394 in combination with cisplatin/etoposide or carboplatin/etoposide chemotherapy in 2 separate cohorts in parallel. (Phase II Part) Evaluate the response rate in subjects with extensive disease SCLC receiving first-line cisplatin/etoposide or carboplatin/etoposide chemotherapy in combination with BAY 1000394. Tumor response will be evaluated based on RECIST 1.1. Tumor measurements will be made at baseline and then every 2 cycles, ie every 6 weeks based on 21-day cycles, until progressive disease will occur.

Study Number: 

PH 225412

Phase: 
I / II
Principal Investigator: 
ClinicalTrials.Gov ID: 
NCT01573338

To inquire about participating in these studies, call 1-877-ASK-RPCI (1-877-275-7724) or e-mail askrpci@roswellpark.org.