Last reviewed · How we verify
Cabozantinib in Patients With Hepatocellular Carcinoma (ACTION)
Phase 2 trial testing Cabozantinib in Hepatocellular Carcinoma in 24 participants. Completed in 22 February 2023.
| Lead sponsor | Fundacion Clinic per a la Recerca Biomédica |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 24 |
| Start date | 31 July 2020 |
| Primary completion | 22 February 2023 |
| Estimated completion | 22 February 2023 |
| Sites | 6 locations across Spain |
Fundacion Clinic per a la Recerca Biomédica
18 and older, any sex, with Hepatocellular Carcinoma. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Percentage of patients with Grade 3 AEs in relation with total number of treated patients
| Group | Value | 95% CI |
|---|---|---|
| Cabozantinib | 16 |
Percentage of patients with AEs in relation with total number of treated patients
| Group | Value | 95% CI |
|---|---|---|
| Cabozantinib | 24 |
Percentage of patients with related AEs in relation with total number of treated patients
| Group | Value | 95% CI |
|---|---|---|
| Cabozantinib | 24 |
Percentage of patients who die during treatment due to adverse events in relation with total number of treated patients
| Group | Value | 95% CI |
|---|---|---|
| Cabozantinib | 0 |
Percentage of patients with AEs leading to treatment discontinuation in relation with total number of treated patients
| Group | Value | 95% CI |
|---|---|---|
| Cabozantinib | 3 |
Time from the date of start of treatment until the date of objective disease progression or death
| Group | Value | 95% CI |
|---|---|---|
| Cabozantinib | 6 | 3 – 8 |
ORR is defined as the number of subjects with a best overall response of a complete response (CR) or partial response (PR) divided by the number of included patients
| Group | Value | 95% CI |
|---|---|---|
| Cabozantinib | 8.3 | 1.0 – 27.0 |
Type of progression divided by number of patients
| Group | Value | 95% CI |
|---|---|---|
| Cabozantinib | 44.4 |
| Group | Value | 95% CI |
|---|---|---|
| Cabozantinib | 22.2 |
| Group | Value | 95% CI |
|---|---|---|
| Cabozantinib | 11.1 |
| Group | Value | 95% CI |
|---|---|---|
| Cabozantinib | 22.2 |
Time from the date of start of treatment until the date of death
| Group | Value | 95% CI |
|---|---|---|
| Cabozantinib | 11 | 8 – 20 |
Time from the date of disease progression until the date of death
| Group | Value | 95% CI |
|---|---|---|
| Cabozantinib | 5 | 2 – NA |
Number of subjects who develop new extra-hepatic spread divided by number of included patients
| Group | Value | 95% CI |
|---|---|---|
| Cabozantinib | 22 |
Time frame: Adverse events were evaluated at each study visit through treatment completion and 30 days after the last dose, an average of 34 weeks.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Cabozantinib |
|---|---|---|
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | — |
| Pyrexia | General disorders | — |
| Rectal haemorrhage | Gastrointestinal disorders | — |
| Intestinal ischaemia | Gastrointestinal disorders | — |
| Cholecystitis acute | Hepatobiliary disorders | — |
| Back pain | Musculoskeletal and connective tissue disorders | — |
| Peritonitis bacterial | Infections and infestations | — |
| Skin infection | Infections and infestations | — |
| Pneumonia | Infections and infestations | — |
| COVID-19 | Infections and infestations | — |
| Reaction | System | Cabozantinib |
|---|---|---|
| Hypertension | Vascular disorders | — |
| Palmar-plantar erythrodysaesthesia syndrome | Skin and subcutaneous tissue disorders | — |
| Fatigue | General disorders | — |
| Diarrhoea | Gastrointestinal disorders | — |
| Asthenia | General disorders | — |
| Aspartate aminotransferase increased | Investigations | — |
| Constipation | Gastrointestinal disorders | — |
| Alanine aminotransferase increased | Investigations | — |
| Abdominal pain upper | Gastrointestinal disorders | — |
| Dyspepsia | Gastrointestinal disorders | — |
| Nausea | Gastrointestinal disorders | — |
| Blood lactate dehydrogenase increased | Investigations | — |
| Abdominal pain | Gastrointestinal disorders | — |
| Pruritus | Skin and subcutaneous tissue disorders | — |
| Hypothyroidism | Endocrine disorders | — |
| COVID-19 | Infections and infestations | — |
| Mucosal inflammation | General disorders | — |
| Ascites | Gastrointestinal disorders | — |
| Vomiting | Gastrointestinal disorders | — |
| Rash | Skin and subcutaneous tissue disorders | — |
| Arthralgia | Musculoskeletal and connective tissue disorders | — |
| Back pain | Musculoskeletal and connective tissue disorders | — |
| Decreased appetite | Metabolism and nutrition disorders | — |
| Discomfort | General disorders | — |
| Oedema | General disorders | — |
| Oedema peripheral | General disorders | — |
| Pyrexia | General disorders | — |
| Decreased appetite | General disorders | — |
| Confusional state | Psychiatric disorders | — |
| Blood bilirubin increased | Investigations | — |
| Blood thyroid stimulating hormone increased | Investigations | — |
| Platelet count decreased | Investigations | — |
| Weight decreased | Investigations | — |
| Blood alkaline phosphatase increased | Investigations | — |
| Joint injury | Injury, poisoning and procedural complications | — |
| Dizziness | Nervous system disorders | — |
| Headache | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | — |
| Tension headache | Nervous system disorders | — |
| Abdominal discomfort | Gastrointestinal disorders | — |
| Oesophagitis | Gastrointestinal disorders | — |
Most-reported serious reactions: Upper gastrointestinal haemorrhage, Pyrexia, Rectal haemorrhage, Intestinal ischaemia, Cholecystitis acute, Back pain, Peritonitis bacterial, Skin infection.
Data from ClinicalTrials.gov NCT04316182 adverse events section.
Cabozantinib, a small molecule directed to vascular endothelial growth factor receptors, MET and AXL, has shown to significantly improve the overall survival (OS) over placebo in the randomized phase 3 CELESTIAL trial in patients who had up to two lines of prior systemic therapy (including sorafenib) with progression on at least one in comparison to patients who received best supportive care. Although cabozantinib shares similar targets with sorafenib/regorafenib, they present different toxicity profile. While the most common grade 3-4 Adverse Events reported for sorafenib were fatigue (4%), diarrhea (8%), hand-foot reaction (8%) and hypertension (2%); the most frequent grade 3-4 Adverse Events for cabozantinib were hand-foot reaction (3.6%), hypertension (3.4%) and elevation of AST (2.6%). In clinical practice, regorafenib, ramucirumab and cabozantinib are approved by European Medicines Agency (EMA) as second-line treatment approved by EMA until now. However, more than 40% of candidate patients to 2nd line do not meet the RESORCE criteria or REACH-2 trial and are only candidates to cabozantinib treatment. However, investigators do not have safety data about those patients who are treated with other treatments than sorafenib in first line neither data about the real impact of sorafenib-intolerant patients according to the RESORCE trial definition. For this reason, investigators propose to explore the role of cabozantinib in patients who were not considered in the CELESTIAL trial.
6 peer-reviewed publications reference this trial (live from Europe PMC):
Verify or expand the search:
Trials testing the same drug.
Currently open trials in the same condition.
Trials by the same sponsor.
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04316182.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing