A Phase 1/2 interventional study of JNJ-42756493 (erdafitinib) in Carcinoma, Hepatocellular, sponsored by Janssen Research & Development, LLC. Completed at 10 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-02-03.
Sponsored by Janssen Research & Development, LLC (part of Johnson & Johnson) · Phase 1/2, Interventional, and Treatment
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.
3,249 studies on the registry are indexed under Carcinoma, Hepatocellular; 974 are open to participants now.
This study's enrollment of 53 is close to the median of 55 across 2,347 interventional studies indexed under Carcinoma, Hepatocellular.
Browse Carcinoma, Hepatocellular studies →Janssen Research & Development, LLC is the lead sponsor of 929 studies on the registry; 76 are open to participants now.
Of its 283 completed or terminated interventional studies of FDA-regulated products, 134 (47%) have results posted.
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Exclusion Criteria:
Part 1: First, participants will receive 8 milligram (mg) (starting dose) tablet of JNJ-42756493 (erdafitinib) orally once daily from Day 1 to 7, then Day 15 to 21 of 28 days cycle or 8 mg orally once daily from Day 1 to 21 of 28 days cycle (intermittent dosing). After recommended Phase 2 dose (RP2D) is identified, enrollment of continuous dosing schedule will be open, starting at 8mg. In this cohort, participants will receive 8mg (starting dose) tablet of JNJ42756493 (erdafitinib) orally once daily from Day 1 to Day 28 in a 28-day cycle. Dose of the study medication will be escalated sequentially till the dose limiting toxicity is achieved to determine RP2D. Part 2: Participants will receive RP2D JNJ-42756493 (erdafitinib) dose determined in Part 1. Participants who are tolerating study drug treatment and achieve clinical responses or stable disease will continue to receive study drug at the same dose until disease progression, unacceptable toxicity, or withdrawal of consent.
Drug: JNJ-42756493 (erdafitinib)
Part 1: Participants will receive 8 mg tablet once daily from Day 1 to 7, and then Day 15 to 21 of 28 days cycle or 8 mg orally once daily of 28 days cycle up to the maximum tolerated dose in order to determine the recommended Phase 2 dose. Part 2: Recommended Phase 2 JNJ-42756493 (erdafitinib) dose determined in Part 1.
Part 1:Recommended Phase 2 Dose (RP2D)
RP2D will be determined based on pharmacodynamics, biomarker response or clinical response, as well as the incidence rate and nature of the toxicities observed.
Time frame: Up to Part 1 Day 84 (Cycle 3, Day 28) (approximately 84 days)
Number of participants with Objective Response
Objective response based on assessment of confirmed Complete response (CR) or partial response (PR) according to modified Response Evaluation Criteria in Solid Tumors (mRECIST) for HCC. CR defined as disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to less than 10 millimeter (mm). PR defined as at least 30 percent (%) decrease in sum of the diameters of the target lesions taking as reference the Baseline sum diameters. Confirmed responses are those that persist on repeat imaging study for at least 4 weeks after initial documentation of response.
Time frame: up to Month 12
Number of Participants With Adverse Events
An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
Time frame: up to Month 12
Time to Progression (TTP)
Time interval in months between the date of randomization and the date of disease progression or death due to progression, whichever occurred first.
Time frame: up to Month 12
Disease Control Rate (DCR)
DCR defined as the proportion of participants with complete response \[CR\], partial response \[PR\], or stable disease \[SD\]), and duration of objective response (DOR).
Time frame: up to Month 12
Progression-free Survival
Time from date of randomization to date of first documentation of objective tumor progression or death due to any cause, whichever occurred first.
Time frame: up to Month 12
Maximum Observed Plasma Concentration of JNJ-42756493 (erdafitinib)
Time frame: Up to Part 2 Day 84 (Cycle 3, Day 28) (approximately 84 days)
Time of Maximum Observed Plasma Concentration of JNJ-42756493 (erdafitinib)
Time frame: Up to Part 2 Day 84 (Cycle 3, Day 28) (approximately 84 days)
Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau)
The AUCtau is the measure of the plasma drug concentration from time zero to end of dosing interval. It is used to characterize drug absorption.
Time frame: Up to Part 2 Day 84 (Cycle 3, Day 28) (approximately 84 days)
Half life of JNJ-42756493 (erdafitinib)
Time frame: Up to Part 2 Day 84 (Cycle 3, Day 28) (approximately 84 days)
Apparent Volume of Distribution at Steady-State of JNJ-42756493 (erdafitinib)
Time frame: Up to Part 2 Day 84 (Cycle 3, Day 28) (approximately 84 days)
Total Clearance of JNJ-42756493 (erdafitinib)
Time frame: Up to Part 2 Day 84 (Cycle 3, Day 28) (approximately 84 days)
Accumulation Index of JNJ-42756493 (erdafitinib)
Time frame: Up to Part 2 Day 84 (Cycle 3, Day 28) (approximately 84 days)
Duration of Objective Response (DOR)
Time frame: Up to Month 12
This study is completed, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Erdafitinib
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