Overview

This trial is active, not recruiting.

Condition carcinoma, hepatocellular
Treatments sorafenib, bibf 1120
Phase phase 2
Targets RAF, VEGF, FGFR, FLT-3, KIT, PDGF
Sponsor Boehringer Ingelheim
Start date October 2009
End date July 2014
Trial size 134 participants
Trial identifier NCT00987935, 1199.39

Summary

This study is to evaluate the safety, appropriate dose, and efficacy of BIBF 1120 in liver cancer patients

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Phase I dose escalation and phase II using dose determined in phase I
bibf 1120
Twice daily
(Active Comparator)
Twice daily dosing in phase II
sorafenib
400 mg twice daily

Primary Outcomes

Measure
Maximum Tolerated Dose in Phase I
time frame: 4 weeks
Time to Progression (TTP) in Phase II
time frame: From randomization until data cut-off (28 Sep 2012); Up to 77 weeks

Secondary Outcomes

Measure
Time to Progression (TTP) in Phase II (Follow-up Analyses)
time frame: 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.
time frame: 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
time frame: 4 weeks
Objective Tumour Response by RECIST
time frame: From randomization until data cut-off (16 July 2014); Up to 171 weeks
Progression Free Survival (PFS)
time frame: From randomization until data cut-off (16 July 2014); Up to 171 weeks
Overall Survival
time frame: 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 Nintedanib
time frame: 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 (Metabolite of Nintedanib)
time frame: 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)
time frame: Day1, Day15 and Day 16
Cmax,ss,Norm (Maximum Concentration of the Nintedanib in Plasma at Steady State, Normalised Values)
time frame: Day1, Day15 and Day 16
Cmax,ss,Norm (Maximum Concentration of the BIBF 1202 in Plasma at Steady State, Normalised Values)
time frame: Day1, Day15 and Day 16
Cmax,ss,Norm (Maximum Concentration of the BIBF 1202 Glucuronide in Plasma at Steady State, Normalised Values)
time frame: Day1, Day15 and Day 16
fe0-12,ss (Fraction Excreted in Urine Between 0 and 12 Hours at Steady State) for Nintedanib
time frame: 0 to 4 hours (h), 4 to 12 h, and 12 to 24 h after nintedanib

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion criteria: 1. Hepatocellular carcinoma, either histologically/cytologically confirmed or clinically diagnosed, which is not amenable to curative surgery or loco-regional therapy 2. Age 18 years or older 3. Eastern Cooperative Group performance score of 2 or less 4. Child-Pugh score of 7 or less 5. Written informed consent in accordance with International Conference on Harmonisation (ICH) and Good Clinical Practice (GCP) and local legislation Exclusion criteria: 1. Prior systemic therapy for metastatic/unresectable hepatocellular carcinoma (for phase II) 2. More than one line of prior systemic therapy for metastatic/unresectable hepatocellular carcinoma (for phase I) 3. Uncontrolled or refractory ascites to adequate medical therapy 4. Bilirubin greater than 1.5 times upper limit of normal 5. Aspartate amino transferase or alanine amino transferase greater than 5 times upper limit of normal 6. Absolute neutrophil count less than 1500/microliter 7. Platelet count less than 75000/microliter 8. Hemoglobin less than 9 g/dL 9. Serum creatinine greater than 1.5 times upper limit of normal

Additional Information

Official title 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.
Trial information was received from ClinicalTrials.gov and was last updated in December 2015.
Information provided to ClinicalTrials.gov by Boehringer Ingelheim.