Combination With Gemcitabine in Advanced Pancreatic Cancer
Status:
Completed
Trial end date:
2013-08-01
Target enrollment:
Participant gender:
Summary
Open-label, uncontrolled, Phase I/II study to evaluate safety and efficacy of BAY86-9766 plus
gemcitabine in locally advanced, unresectable or metastatic pancreatic cancer.
Phase I: Dose escalation study investigating 20, 30 and 50 mg BAY86-9766 plus gemcitabine
(1000mg/m2); determination of maximum tolerated dose and recommended phase 2 dose.
Phase II: Determination of response (RECIST 1.1; primary endpoint). Secondary endpoints:
response duration, disease control rate, time to progression, progression-free survival,
overall survival, safety and tolerability.
Tumor assessments at Screening and than every 8 weeks.; Safety evaluations at Screening and
weekly throughout the study; Safety follow-up visit 30 days after the last dose of study
treatment; Survival follow up monthly for up to 8 month after LPFV.