Ignite Creation Date:
2024-05-06 @ 2:25 PM
Last Modification Date:
2024-10-26 @ 1:31 PM
Study NCT ID:
NCT04316182
Status:
COMPLETED
Last Update Posted:
2023-12-29
First Post:
2020-03-18
Brief Title:
Cabozantinib in Patients With Hepatocellular Carcinoma ACTION
Sponsor:
Fundacion Clinic per a la Recerca Biomédica
Organization:
Fundacion Clinic per a la Recerca Biomédica
Study Overview
Official Title:
A Phase II triAl of Cabozantinib for hepaTocellular carcInoma Patients intOlerant to Sorafenib Treatment or First Line Treatment Different to sorafeNib ACTION Trial
Status:
COMPLETED
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ACTION
Brief Summary:
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 sorafenibregorafenib 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 36 hypertension 34 and elevation of AST 26
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
Although cabozantinib shares similar targets with sorafenibregorafenib 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 36 hypertension 34 and elevation of AST 26
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2019-004991-20 | EUDRACT_NUMBER | None | None |