A Multicenter, Open Label, Phase I/Randomized II Study to Evaluate Safety, Pharmacokinetics and Efficacy of BIBF 1120 in Comparison With Sorafenib for Advanced Hepatocellular Carcinoma Patients in Asia.

简要总结

主要结局

次要结局

• Progression Free Survival (PFS)(From randomization until data cut-off (16 July 2014); Up to 171 weeks)
• Overall Survival(From randomization until data cut-off (16 July 2014); Up to 171 weeks)
• fe0-12,ss (Fraction Excreted in Urine Between 0 and 12 Hours at Steady State) for Nintedanib(0 to 4 hours (h), 4 to 12 h, and 12 to 24 h after nintedanib)
• Time to Progression (TTP) in Phase II (Follow-up Analyses)(From randomization until disease progression or data cut-off (16 Jul 2014); Up to 171 weeks)
• Incidence and Intensity of Adverse Events (AEs) Reported as the Number of Patients With AEs According to Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 Throughout the Treatment Period.(AEs with an onset during therapy with study treatment or within 28 days after discontinuation of study treatment (up to 1066 days))
• Incidence of Dose Limiting Toxicity in Phase I(4 weeks)
• AUC0-12,ss,Norm (Area Under the Plasma Concentration-time Curve Between 0 and 12 Hours at Steady State, Normalised Values) of Nintedanib(Day1, Day15 and Day 16)
• Objective Tumour Response by RECIST(From randomization until data cut-off (16 July 2014); Up to 171 weeks)
• AUC0-12,ss,Norm (Area Under the Plasma Concentration-time Curve Between 0 and 12 Hours at Steady State, Normalised Values) of BIBF 1202 (Metabolite of Nintedanib)(Day1, Day15 and Day 16)
• AUC0-12,ss,Norm (Area Under the Plasma Concentration-time Curve Between 0 and 12 Hours at Steady State, Normalised Values) of BIBF 1202 Glucuronide (Metabolite of Nintedanib)(Day1, Day15 and Day 16)
• Cmax,ss,Norm (Maximum Concentration of the Nintedanib in Plasma at Steady State, Normalised Values)(Day1, Day15 and Day 16)
• Cmax,ss,Norm (Maximum Concentration of the BIBF 1202 in Plasma at Steady State, Normalised Values)(Day1, Day15 and Day 16)
• Cmax,ss,Norm (Maximum Concentration of the BIBF 1202 Glucuronide in Plasma at Steady State, Normalised Values)(Day1, Day15 and Day 16)