Trial Outcomes & Findings for Itacitinib in Advanced Hepatocellular Carcinoma (NCT NCT04358185)
NCT ID: NCT04358185
Last Updated: 2026-05-04
Results Overview
Assessment of adverse events relating to experimental drug intake according to the Common Terminology Criteria for Adverse Events (CTCAE) V4.03. An adverse event (AE) is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which dose not necessarily have a casual relationship with this treatment. An AE can therefore be any unfavourable and unintended (including an abnormal laboratory finding), symptoms, or disease temporally associated with the use of an investigational medicinal project (IMP), whether or not considered related to the IMP. Treatment-related adverse events (TrAE) are AEs that are possibly, probably, or likely related to the IMP. Here, TrAEs are reported.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
19 participants
Primary outcome timeframe
Throughout study completion, up to 1 year
Results posted on
2026-05-04
Participant Flow
Participant milestones
| Measure |
Itacitinib
Itacitinib (INCB039110): Novel and small molecule selective inhibitor of JAK1
|
|---|---|
|
Overall Study
STARTED
|
19
|
|
Overall Study
COMPLETED
|
15
|
|
Overall Study
NOT COMPLETED
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Itacitinib
n=19 Participants
Itacitinib (INCB039110) - novel and small molecule selective inhibitor of JAK1
Itacitinib (INCB039110): Novel and small molecule selective inhibitor of JAK1
|
|---|---|
|
Age, Continuous
|
66 Years
n=19 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=19 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=19 Participants
|
|
Region of Enrollment
United Kingdom
|
19 Participants
n=19 Participants
|
|
Child-Pugh class
Class A
|
15 Participants
n=19 Participants
|
|
Child-Pugh class
Class B
|
4 Participants
n=19 Participants
|
|
BCLC Stage
Stage B
|
7 Participants
n=19 Participants
|
|
BCLC Stage
Stage C
|
12 Participants
n=19 Participants
|
|
ECOG Performance Score
0
|
11 Participants
n=19 Participants
|
|
ECOG Performance Score
1
|
8 Participants
n=19 Participants
|
|
Cirrhosis
|
18 Participants
n=19 Participants
|
|
Portal Vein Thrombosis (PVT)
|
7 Participants
n=19 Participants
|
PRIMARY outcome
Timeframe: Throughout study completion, up to 1 yearAssessment of adverse events relating to experimental drug intake according to the Common Terminology Criteria for Adverse Events (CTCAE) V4.03. An adverse event (AE) is any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which dose not necessarily have a casual relationship with this treatment. An AE can therefore be any unfavourable and unintended (including an abnormal laboratory finding), symptoms, or disease temporally associated with the use of an investigational medicinal project (IMP), whether or not considered related to the IMP. Treatment-related adverse events (TrAE) are AEs that are possibly, probably, or likely related to the IMP. Here, TrAEs are reported.
Outcome measures
| Measure |
Itacitinib
n=19 Participants
Itacitinib (INCB039110): Novel and small molecule selective inhibitor of JAK1
|
|---|---|
|
To Assess the Safety and Tolerability of Itacitinib in Patients With HCC: Adverse Events
|
14 Participants
|
PRIMARY outcome
Timeframe: Throughout study completion, up to 1 yearPopulation: Four participants did not undergo radiologic evaluation (one patient was withdrawn from the study due to lack of compliance, two experiences severe AE's that led to treatment cessation and one did following cycle 1).
The Response Evaluation Criteria in Solid Tumours (RECIST) criteria v1.1. classifies response based on the assessment of target and non-target lesions on CT scans as: * Complete Response (CR): requires all of: * disappearance of all target and non-target lesions * pathological lymph nodes must have reduced to \<10 mm in short axis * no new lesions * Partial Response (PR): requires all of: * at least 30% decrease in sum of diameters (SOD) of target lesions compared to baseline sum diameters * non-progressive disease of non-target lesions * no new lesions * Progressive Disease (PD): either one of: * any new lesions * at least 20% relative and 5 mm absolute increase of SOD of target lesions compared to smallest SOD ever recorded for the patient * Stable Disease (SD): not meeting criteria for PD or PR.
Outcome measures
| Measure |
Itacitinib
n=15 Participants
Itacitinib (INCB039110): Novel and small molecule selective inhibitor of JAK1
|
|---|---|
|
To Assess Efficacy of Itacitinib by Overall Response Rate: Objective Response Rate (ORR)
Complete Response
|
0 Participants
|
|
To Assess Efficacy of Itacitinib by Overall Response Rate: Objective Response Rate (ORR)
Partial Response
|
0 Participants
|
|
To Assess Efficacy of Itacitinib by Overall Response Rate: Objective Response Rate (ORR)
Stable Disease
|
7 Participants
|
|
To Assess Efficacy of Itacitinib by Overall Response Rate: Objective Response Rate (ORR)
Progressive Disease
|
8 Participants
|
SECONDARY outcome
Timeframe: Throughout study completion, up to 1 yearProgression free survival (PFS), defined as time from study entry to first evidence of disease progression assessed by RECIST or death due to any cause.
Outcome measures
| Measure |
Itacitinib
n=19 Participants
Itacitinib (INCB039110): Novel and small molecule selective inhibitor of JAK1
|
|---|---|
|
Efficacy of Itacitinib by Progression Free Survival
|
3.5 months
Interval 2.6 to 4.5
|
SECONDARY outcome
Timeframe: Throughout study completion, up to 1 yearOverall survival (OS), defined as time from study entry to death due to any cause.
Outcome measures
| Measure |
Itacitinib
n=19 Participants
Itacitinib (INCB039110): Novel and small molecule selective inhibitor of JAK1
|
|---|---|
|
Efficacy of Itacitinib by Overall Survival
|
7.4 months
Interval 4.3 to 10.5
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Throughout study completion, up to 1 yearCorrelation of changes in proinflammatory cytokines (multiplex bead array) with treatment response (mRECIST)
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Throughout study completion, up to 1 yearUsing mRECIST to find the correlation between the presence of predefined JAK1 mutations in tumour tissue with treatment outcome
Outcome measures
Outcome data not reported
Adverse Events
Overall Study
Serious events: 10 serious events
Other events: 14 other events
Deaths: 16 deaths
Serious adverse events
| Measure |
Overall Study
n=19 participants at risk
Itacitinib (INCB039110): Novel and small molecule selective inhibitor of JAK1.
|
|---|---|
|
Renal and urinary disorders
Acute kidney injury
|
10.5%
2/19 • Number of events 2 • Throughout study completion, up to 1 year.
|
|
Infections and infestations
Coronavirus infection
|
10.5%
2/19 • Number of events 2 • Throughout study completion, up to 1 year.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
10.5%
2/19 • Number of events 2 • Throughout study completion, up to 1 year.
|
|
Nervous system disorders
Spinal cord compression
|
10.5%
2/19 • Number of events 2 • Throughout study completion, up to 1 year.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
10.5%
2/19 • Number of events 2 • Throughout study completion, up to 1 year.
|
|
Blood and lymphatic system disorders
Anaemia
|
5.3%
1/19 • Number of events 1 • Throughout study completion, up to 1 year.
|
|
Hepatobiliary disorders
Biliary sepsis
|
5.3%
1/19 • Number of events 1 • Throughout study completion, up to 1 year.
|
|
Cardiac disorders
Cardiac failure congestive
|
5.3%
1/19 • Number of events 1 • Throughout study completion, up to 1 year.
|
|
Nervous system disorders
Encephalopathy
|
5.3%
1/19 • Number of events 1 • Throughout study completion, up to 1 year.
|
|
Gastrointestinal disorders
Frequent bowel movements
|
5.3%
1/19 • Number of events 1 • Throughout study completion, up to 1 year.
|
|
Hepatobiliary disorders
Hepatic failure
|
5.3%
1/19 • Number of events 1 • Throughout study completion, up to 1 year.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
5.3%
1/19 • Number of events 1 • Throughout study completion, up to 1 year.
|
|
Hepatobiliary disorders
Liver injury
|
5.3%
1/19 • Number of events 1 • Throughout study completion, up to 1 year.
|
|
Renal and urinary disorders
Urinary tract infection
|
5.3%
1/19 • Number of events 1 • Throughout study completion, up to 1 year.
|
Other adverse events
| Measure |
Overall Study
n=19 participants at risk
Itacitinib (INCB039110): Novel and small molecule selective inhibitor of JAK1.
|
|---|---|
|
Gastrointestinal disorders
Vomiting
|
26.3%
5/19 • Number of events 8 • Throughout study completion, up to 1 year.
|
|
Nervous system disorders
Dysgeusia
|
26.3%
5/19 • Number of events 7 • Throughout study completion, up to 1 year.
|
|
Gastrointestinal disorders
Constipation
|
21.1%
4/19 • Number of events 6 • Throughout study completion, up to 1 year.
|
|
Gastrointestinal disorders
Diarrhoea
|
15.8%
3/19 • Number of events 6 • Throughout study completion, up to 1 year.
|
|
General disorders
Mucosal inflammation
|
26.3%
5/19 • Number of events 6 • Throughout study completion, up to 1 year.
|
|
Skin and subcutaneous tissue disorders
Rash
|
21.1%
4/19 • Number of events 5 • Throughout study completion, up to 1 year.
|
|
Nervous system disorders
Palmar-plantar erythrodysaesthesia syndrome
|
21.1%
4/19 • Number of events 4 • Throughout study completion, up to 1 year.
|
|
Blood and lymphatic system disorders
Anaemia
|
15.8%
3/19 • Number of events 3 • Throughout study completion, up to 1 year.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.3%
1/19 • Number of events 1 • Throughout study completion, up to 1 year.
|
|
Cardiac disorders
Dyspnoea
|
15.8%
3/19 • Number of events 3 • Throughout study completion, up to 1 year.
|
|
Infections and infestations
Lower respiratory tract infection
|
10.5%
2/19 • Number of events 3 • Throughout study completion, up to 1 year.
|
|
General disorders
Pyrexia
|
10.5%
2/19 • Number of events 3 • Throughout study completion, up to 1 year.
|
|
General disorders
Swelling
|
10.5%
2/19 • Number of events 3 • Throughout study completion, up to 1 year.
|
|
Renal and urinary disorders
Urinary tract infection
|
15.8%
3/19 • Number of events 3 • Throughout study completion, up to 1 year.
|
|
Gastrointestinal disorders
Abdominal pain
|
10.5%
2/19 • Number of events 2 • Throughout study completion, up to 1 year.
|
|
Investigations
Aspartate aminotransferase increased
|
10.5%
2/19 • Number of events 2 • Throughout study completion, up to 1 year.
|
|
General disorders
Chest pain
|
10.5%
2/19 • Number of events 2 • Throughout study completion, up to 1 year.
|
|
Nervous system disorders
Dizziness
|
10.5%
2/19 • Number of events 2 • Throughout study completion, up to 1 year.
|
|
Vascular disorders
Epistaxis
|
10.5%
2/19 • Number of events 2 • Throughout study completion, up to 1 year.
|
|
Renal and urinary disorders
Haematuria
|
5.3%
1/19 • Number of events 2 • Throughout study completion, up to 1 year.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
10.5%
2/19 • Number of events 2 • Throughout study completion, up to 1 year.
|
|
Nervous system disorders
Hypoaesthesia
|
10.5%
2/19 • Number of events 2 • Throughout study completion, up to 1 year.
|
|
General disorders
Oedema peripheral
|
10.5%
2/19 • Number of events 2 • Throughout study completion, up to 1 year.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
5.3%
1/19 • Number of events 2 • Throughout study completion, up to 1 year.
|
|
Renal and urinary disorders
Acute kidney injury
|
5.3%
1/19 • Number of events 1 • Throughout study completion, up to 1 year.
|
|
Investigations
Alanine aminotransferase increase
|
5.3%
1/19 • Number of events 1 • Throughout study completion, up to 1 year.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
5.3%
1/19 • Number of events 1 • Throughout study completion, up to 1 year.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.3%
1/19 • Number of events 1 • Throughout study completion, up to 1 year.
|
|
Investigations
Blood bilirubin increased
|
5.3%
1/19 • Number of events 1 • Throughout study completion, up to 1 year.
|
|
Investigations
Blood creatinine increased
|
5.3%
1/19 • Number of events 1 • Throughout study completion, up to 1 year.
|
|
Investigations
Blood triglycerides increased
|
5.3%
1/19 • Number of events 1 • Throughout study completion, up to 1 year.
|
|
Skin and subcutaneous tissue disorders
Cellulitis
|
5.3%
1/19 • Number of events 1 • Throughout study completion, up to 1 year.
|
|
Hepatobiliary disorders
Cholangitis
|
5.3%
1/19 • Number of events 1 • Throughout study completion, up to 1 year.
|
|
Infections and infestations
Coronavirus infection
|
5.3%
1/19 • Number of events 1 • Throughout study completion, up to 1 year.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
5.3%
1/19 • Number of events 1 • Throughout study completion, up to 1 year.
|
|
Gastrointestinal disorders
Gingival bleeding
|
5.3%
1/19 • Number of events 1 • Throughout study completion, up to 1 year.
|
|
Musculoskeletal and connective tissue disorders
Gout
|
5.3%
1/19 • Number of events 1 • Throughout study completion, up to 1 year.
|
|
Hepatobiliary disorders
Hepatic pain
|
5.3%
1/19 • Number of events 1 • Throughout study completion, up to 1 year.
|
|
Endocrine disorders
Hyperglycaemia
|
5.3%
1/19 • Number of events 1 • Throughout study completion, up to 1 year.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
5.3%
1/19 • Number of events 1 • Throughout study completion, up to 1 year.
|
|
Nervous system disorders
Insomnia
|
5.3%
1/19 • Number of events 1 • Throughout study completion, up to 1 year.
|
|
Cardiac disorders
Left ventricular dysfunction
|
5.3%
1/19 • Number of events 1 • Throughout study completion, up to 1 year.
|
|
Nervous system disorders
Lethargy
|
5.3%
1/19 • Number of events 1 • Throughout study completion, up to 1 year.
|
|
Gastrointestinal disorders
Lip ulceration
|
5.3%
1/19 • Number of events 1 • Throughout study completion, up to 1 year.
|
|
Psychiatric disorders
Mood swings
|
5.3%
1/19 • Number of events 1 • Throughout study completion, up to 1 year.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
5.3%
1/19 • Number of events 1 • Throughout study completion, up to 1 year.
|
|
Blood and lymphatic system disorders
Neutropenia
|
5.3%
1/19 • Number of events 1 • Throughout study completion, up to 1 year.
|
|
Renal and urinary disorders
Nocturia
|
5.3%
1/19 • Number of events 1 • Throughout study completion, up to 1 year.
|
|
Gastrointestinal disorders
Oral candidiasis
|
5.3%
1/19 • Number of events 1 • Throughout study completion, up to 1 year.
|
|
Investigations
Oxygen saturation
|
5.3%
1/19 • Number of events 1 • Throughout study completion, up to 1 year.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
5.3%
1/19 • Number of events 1 • Throughout study completion, up to 1 year.
|
|
Investigations
Platelet count decreased
|
5.3%
1/19 • Number of events 1 • Throughout study completion, up to 1 year.
|
|
Renal and urinary disorders
Polyuria
|
5.3%
1/19 • Number of events 1 • Throughout study completion, up to 1 year.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
5.3%
1/19 • Number of events 1 • Throughout study completion, up to 1 year.
|
|
Immune system disorders
Psoriasis
|
5.3%
1/19 • Number of events 1 • Throughout study completion, up to 1 year.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
5.3%
1/19 • Number of events 1 • Throughout study completion, up to 1 year.
|
|
Cardiac disorders
Supraventricular tachycardia
|
5.3%
1/19 • Number of events 1 • Throughout study completion, up to 1 year.
|
|
Reproductive system and breast disorders
Testicular pain
|
5.3%
1/19 • Number of events 1 • Throughout study completion, up to 1 year.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
5.3%
1/19 • Number of events 1 • Throughout study completion, up to 1 year.
|
|
Gastrointestinal disorders
Tooth abscess
|
5.3%
1/19 • Number of events 1 • Throughout study completion, up to 1 year.
|
|
Investigations
Weight decreased
|
5.3%
1/19 • Number of events 1 • Throughout study completion, up to 1 year.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
47.4%
9/19 • Number of events 10 • Throughout study completion, up to 1 year.
|
|
General disorders
Pain
|
26.3%
5/19 • Number of events 10 • Throughout study completion, up to 1 year.
|
|
Gastrointestinal disorders
Nausea
|
31.6%
6/19 • Number of events 8 • Throughout study completion, up to 1 year.
|
|
General disorders
Fatigue
|
57.9%
11/19 • Number of events 15 • Throughout study completion, up to 1 year.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
42.1%
8/19 • Number of events 13 • Throughout study completion, up to 1 year.
|
|
Vascular disorders
Hypertension
|
42.1%
8/19 • Number of events 13 • Throughout study completion, up to 1 year.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place