Phase 2
N=134
A Phase I / II Trial of Nintedanib in Asian Hepatocellular Carcinoma Patients
Carcinoma, Hepatocellular
Bottom Line
View on ClinicalTrials.gov: NCT00987935 ↗Enrolled (actual)
134
Serious AEs
50.7%
Results posted
Aug 2015
Primary outcome: Primary: Maximum Tolerated Dose in Phase I — 200; 200 mg
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Sorafenib (Drug); BIBF 1120 (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Boehringer Ingelheim
- Primary completion
- Jul 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maximum Tolerated Dose in Phase I |
200; 200 | — |
| PRIMARY Time to Progression (TTP) in Phase II |
2.73; 3.71 | — |
| SECONDARY Time to Progression (TTP) in Phase II (Follow-up Analyses) |
2.76; 3.71 | — |
| SECONDARY 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. |
0; 0; 1; 0; 1; 0 | — |
| SECONDARY Incidence of Dose Limiting Toxicity in Phase I |
0; 0; 0; 0; 1; 0 | — |
| SECONDARY Objective Tumour Response by RECIST |
6.3; 3.1 | — |
| SECONDARY Progression Free Survival (PFS) |
2.66; 3.71 | — |
| SECONDARY Overall Survival |
10.18; 10.71 | — |
| SECONDARY AUC0-12,ss,Norm (Area Under the Plasma Concentration-time Curve Between 0 and 12 Hours at Steady State, Normalised Values) of Nintedanib |
1.97; 3.82 | — |
| SECONDARY 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) |
3.50; 8.95 | — |
| SECONDARY 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) |
16.9; 45.0 | — |
| SECONDARY Cmax,ss,Norm (Maximum Concentration of the Nintedanib in Plasma at Steady State, Normalised Values) |
0.348; 0.630 | — |
| SECONDARY Cmax,ss,Norm (Maximum Concentration of the BIBF 1202 in Plasma at Steady State, Normalised Values) |
0.519; 1.01 | — |
| SECONDARY Cmax,ss,Norm (Maximum Concentration of the BIBF 1202 Glucuronide in Plasma at Steady State, Normalised Values) |
1.56; 3.48 | — |
| SECONDARY fe0-12,ss (Fraction Excreted in Urine Between 0 and 12 Hours at Steady State) for Nintedanib |
0.227; 0.286 | — |
Summary
This study is to evaluate the safety, appropriate dose, and efficacy of BIBF 1120 in liver cancer patients
Eligibility Criteria
Inclusion criteria
- Hepatocellular carcinoma, either histologically/cytologically confirmed or clinically diagnosed, which is not amenable to curative surgery or loco-regional therapy
- Age 18 years or older
- Eastern Cooperative Group performance score of 2 or less
- Child-Pugh score of 7 or less
- Written informed consent in accordance with International Conference on Harmonisation (ICH) and Good Clinical Practice (GCP) and local legislation
Exclusion criteria
- Prior systemic therapy for metastatic/unresectable hepatocellular carcinoma (for phase II)
- More than one line of prior systemic therapy for metastatic/unresectable hepatocellular carcinoma (for phase I)
- Uncontrolled or refractory ascites to adequate medical therapy
- Bilirubin greater than 1.5 times upper limit of normal
- Aspartate amino transferase or alanine amino transferase greater than 5 times upper limit of normal
- Absolute neutrophil count less than 1500/microliter
- Platelet count less than 75000/microliter
- Hemoglobin less than 9 g/dL
- Serum creatinine greater than 1.5 times upper limit of normal
Data sourced from ClinicalTrials.gov (NCT00987935). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.