Carcinoma, Hepatocellular Clinical Trial
Official title:
A Phase 1/2a Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of JNJ-42756493, a Pan-Fibroblast Growth Factor Receptor (FGFR) Tyrosine Kinase Inhibitor, in Subjects With Advanced Hepatocellular Carcinoma
The purpose of this study is to determine recommended Phase 2 dose [RP2D]) and the objective response rate of JNJ-42756493 (erdafitinib) in advanced hepatocellular carcinoma (HCC) participants with fibroblast growth factor (FGF) 19 amplification.
This is an open-label (all people know the identity of the intervention), multicenter (when more than one hospital or medical school team work on a medical research study), 2 parts (First, dose escalation Phase and second, dose expansion Phase) study to evaluate the safety, pharmacokinetics, pharmacodynamics, and clinical responses of JNJ-42756493 (erdafitinib) in Asian participants with advanced HCC. The duration of study will be approximately 11 months per participant. The study consists of 2 periods: Screening (28 days before study commences on Day 1); Open-label Treatment (dose escalation portion of the trial [Part 1]), participants are enrolled into cohorts at increasing dose levels of JNJ-42756493 (erdafitinib) in 28 day treatment cycles. Part 2, the cohort expansion part of the trial, will further explore the recommended phase 2 dose (RP2D) of JNJ-42756493 (erdafitinib) as determined in Part 1; and follow-up Phase (up to 6 months). Blood samples will be collected for evaluation of safety, pharmacokinetics, pharmacodynamics, and predictive biomarkers at pre-dose and post-dose of study treatment. Recommended Phase 2 dose (RP2D) for JNJ-42756493 (erdafitinib) will be evaluated primarily. Participants' safety will be monitored throughout the study. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT03289533 -
A Study Of Avelumab In Combination With Axitinib In Advanced HCC (VEGF Liver 100)
|
Phase 1 | |
| Terminated |
NCT01141478 -
Proton Radiotherapy Plus Sorafenib Versus Sorafenib for Patients With HCC Exceeding San Francisco Criteria
|
N/A | |
| Recruiting |
NCT05580835 -
PET / MR With PSMA for Diagnosis and Staging of Hepatocellular Carcinoma
|
N/A | |
| Active, not recruiting |
NCT05389527 -
Pembrolizumab and Lenvatinib for Resectable Hepatocellular Carcinoma
|
Phase 2 | |
| Not yet recruiting |
NCT04560751 -
TACE Combined With Lenvatinib for Unresectable Hepatocellular Carcinoma (Prolong)
|
||
| Withdrawn |
NCT02939807 -
A Phase II Study of ABC294640 as Monotherapy in Patients With Advanced Hepatocellular Carcinoma
|
Phase 2 | |
| Completed |
NCT01915602 -
Refametinib in Combination With Sorafenib in RAS Mutant Hepatocellular Carcinoma (HCC)
|
Phase 2 | |
| Completed |
NCT04970212 -
Safety and Effectiveness of BioTraceIO Lite for Tissue Damage Assessment Following Liver Tissue Ablation Procedures
|
||
| Recruiting |
NCT02403544 -
Phase I Study of Image-Guided Radiation Concurrent With Double-Agent Chemotherapy for Hepatocellular Carcinoma
|
Phase 1 | |
| Completed |
NCT01897038 -
A Safety, Tolerability, and Pharmacokinetics Study of Onartuzumab as Single Agent or in Combination With Sorafenib in Participants With Advanced Hepatocellular Carcinoma
|
Phase 1 | |
| Terminated |
NCT01337492 -
Pilot Study Sorafenib as Bridge to Orthotopic Liver Transplantation (OLT)
|
Phase 0 | |
| Terminated |
NCT01020812 -
Combination SBRT With TACE for Unresectable Hepatocellular Carcinoma
|
Phase 1/Phase 2 | |
| Completed |
NCT01012011 -
Regulatory Post Marketing Surveillance Study on Nexavar®
|
N/A | |
| Completed |
NCT01003015 -
Safety Study of BAY73-4506 in Patients With Hepatocellular Carcinoma
|
Phase 2 | |
| Completed |
NCT00559455 -
Phase II Study of Eloxatin+5-FU/LV in Patients With Unresectable Hepatocellular Carcinoma
|
Phase 2 | |
| Recruiting |
NCT00384800 -
A Phase II Study of Tegafur/Uracil (UFUR®)Plus Thalidomide for the Treatment of Advanced or Metastatic Hepatocellular Carcinoma (HCC)
|
Phase 2 | |
| Terminated |
NCT00582400 -
A Phase II Protocol of Arsenic Trioxide (Trisenox) in Subjects With Advanced Primary Carcinoma of the Liver
|
Phase 2 | |
| Completed |
NCT00056992 -
Testing of ADI-PEG in Hepatocellular Carcinoma
|
Phase 2 | |
| Completed |
NCT02859324 -
A Safety and Efficacy Study of CC-122 in Combination With Nivolumab in Subjects With Unresectable Hepatocellular Carcinoma (HCC)
|
Phase 1/Phase 2 | |
| Terminated |
NCT02439008 -
Early Biomarkers of Tumor Response in High Dose Hypofractionated Radiotherapy Word Package 3 : Immune Response
|
N/A |