Clinical trial • Phase III • Oncology
Cabozantinib for Hepatocellular carcinoma
Phase III trial of Cabozantinib for Hepatocellular carcinoma.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Hepatocellular carcinoma
- Trial Stage
- Phase III
- Drug Modality
- Small molecule|Monoclonal antibody
- Orphan Drug
- Yes
Key dates
- Initial CTIS Submission Date
- 27-09-2024
- First CTIS Authorization Date
- 14-10-2024
Trial design
Randomised, open-label, sorafenib (nexavar 200 mg film-coated tablets) — comparator arm; dosing schedule not specified in ctis record (product information shows nexavar 200 mg tablets, max daily dose 800 mg).-controlled Phase III trial across 6 sites in Belgium, France, Hungary and others.
- Randomised
- Yes
- Open Label
- Yes
- Comparator
- Sorafenib (Nexavar 200 mg film-coated tablets) — comparator arm; dosing schedule not specified in CTIS record (product information shows Nexavar 200 mg tablets, max daily dose 800 mg).
- Target Sample Size
- 575
Eligibility
Recruits 575 No vulnerable population selected (isVulnerablePopulationSelected=false). Subject information and informed consent forms are provided for adults in multiple languages; no assent procedures or special consent for minors are specified in the CTIS record..
- Vulnerable Population
- No vulnerable population selected (isVulnerablePopulationSelected=false). Subject information and informed consent forms are provided for adults in multiple languages; no assent procedures or special consent for minors are specified in the CTIS record.
Inclusion criteria
- {"criterion_text":"- Histological or cytological diagnosis of HCC or clinical diagnosis of HCC in cirrhotic patients by multiphase imaging using CT or MRI per the American Association for the Study of Liver Diseases (AASLD) guidelines or European Association for the Study of the Liver (EASL 2018)"}
- {"criterion_text":"- The subject has disease that is not amenable to a curative treatment approach (eg, transplant, surgery, ablation therapy) or locoregional therapy (eg, TACE)."}
- {"criterion_text":"- Measurable disease per RECIST 1.1 as determined by the Investigator. Barcelona Clinic Liver Cancer (BCLC) stage Category B or C."}
- {"criterion_text":"- Child-Pugh Score of A."}
- {"criterion_text":"- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1."}
Exclusion criteria
- {"criterion_text":"- Known fibrolamellar carcinoma, sarcomatoid HCC or mixed hepatocellular cholangiocarcinoma."}
- {"criterion_text":"- Prior systemic anticancer therapy for advanced HCC including but not limited to chemotherapy, small molecule kinase inhibitors, and ICIs. Subjects who have received local intratumoral or arterial chemotherapy are eligible. Subjects who have received any local anticancer therapy within 28 days prior to randomization are ineligible"}
- {"criterion_text":"- Radiation therapy for bone metastasis within 2 weeks, any other external beam radiation therapy within 8 weeks prior to randomization."}
- {"criterion_text":"- Known brain metastases or cranial epidural disease unless adequately treated with radiotherapy and/or surgery (including radiosurgery) and stable for at least 8 weeks prior to randomization."}
- {"criterion_text":"- Concomitant anticoagulation with oral anticoagulants."}
Endpoints
Primary endpoints
- {"endpoint_text":"- Duration of Progression Free Survival (PFS) per RECIST 1.1, by Blinded Independent Radiology Committee (BIRC) for the experimental arm (cabozantinib+atezolizumab) vs the control arm ( sorafenib)","definition_or_measurement_approach":"Per RECIST 1.1 assessed by a Blinded Independent Radiology Committee (BIRC); compares PFS for cabozantinib+atezolizumab vs sorafenib."}
- {"endpoint_text":"- Duration of Overall Survival (OS) for the experimental arm (cabozantinib+atezolizumab) vs the control arm (sorafenib)","definition_or_measurement_approach":"Duration of overall survival (OS) comparing experimental arm (cabozantinib+atezolizumab) versus control arm (sorafenib)."}
Secondary endpoints
- {"endpoint_text":"- PFS per RECIST 1.1 by BIRC for the single-agent cabozantinib arm vs the control arm (sorafenib)","definition_or_measurement_approach":"PFS per RECIST 1.1 as assessed by a Blinded Independent Radiology Committee (BIRC) comparing single-agent cabozantinib versus sorafenib."}
Recruitment
- Planned Sample Size
- 575
- Recruitment Window Months
- 87
- Consent Approach
- Informed consent obtained from adult participants. Subject information and informed consent forms (SIS-ICF / ICF) are provided in multiple country-specific documents and languages (examples in CTIS: French, Dutch, Hungarian, Romanian, Spanish). There are specific ICF variants labelled for adults and for pregnant partners; no assent or minor-specific consent documents are listed in the CTIS record.
Geography
- Total Number Of Sites
- 6
- Total Number Of Participants
- 7
Belgium
- Latest Decision Or Authorization Date
- 14-10-2024
- Number Of Sites
- 1
- Number Of Participants
- 1
Sites
- Site Name
- Centre Hospitalier Universitaire De Liege
- Department Name
- Gastroenterology Department
- Principal Investigator Name
- Jean Delwaide
- Principal Investigator Email
- jean.delwaide@chuliege.be
- Contact Person Name
- Jean Delwaide
- Contact Person Email
- jean.delwaide@chuliege.be
France
- Latest Decision Or Authorization Date
- 14-10-2024
- Number Of Sites
- 1
- Number Of Participants
- 1
Sites
- Site Name
- CHRU De Nancy
- Department Name
- Hepato-Gastro-Enterology
- Principal Investigator Name
- Jean Pierre Bronowicki
- Principal Investigator Email
- jp.bronowicki@chru-nancy.fr
- Contact Person Name
- Jean Pierre Bronowicki
- Contact Person Email
- jp.bronowicki@chru-nancy.fr
Hungary
- Latest Decision Or Authorization Date
- 14-10-2024
- Number Of Sites
- 1
- Number Of Participants
- 1
Sites
- Site Name
- University Of Debrecen
- Department Name
- Oncologiai Klinika
- Principal Investigator Name
- Peter Arkosy
- Principal Investigator Email
- arkosy.peter@med.unideb.hu
- Contact Person Name
- Peter Arkosy
- Contact Person Email
- arkosy.peter@med.unideb.hu
Romania
- Latest Decision Or Authorization Date
- 21-10-2024
- Number Of Sites
- 1
- Number Of Participants
- 2
Sites
- Site Name
- Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca
- Department Name
- Oncologie Medicala
- Principal Investigator Name
- Tudor-Eliade Ciuleanu
- Principal Investigator Email
- office@iocn.ro
- Contact Person Name
- Tudor-Eliade Ciuleanu
- Contact Person Email
- office@iocn.ro
Spain
- Latest Decision Or Authorization Date
- 14-10-2024
- Number Of Sites
- 2
- Number Of Participants
- 2
Sites
- Site Name
- Hospital Universitario Puerta De Hierro De Majadahonda
- Department Name
- Gastroenterology Department
- Principal Investigator Name
- Jose Luis Calleja Panero
- Principal Investigator Email
- joseluis.calleja@uam.es
- Contact Person Name
- Jose Luis Calleja Panero
- Contact Person Email
- joseluis.calleja@uam.es
- Site Name
- Institut Catala D'oncologia
- Department Name
- Gastroenterology Department
- Principal Investigator Name
- Mariona Calva Campos
- Principal Investigator Email
- mcalvo@idibell.cat
- Contact Person Name
- Mariona Calva Campos
- Contact Person Email
- mcalvo@idibell.cat
Sponsor
Primary sponsor
- Full Name
- Exelixis Inc.
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- United States
Contract research organisations
- Name
- Icon Clinical Research Limited
- Responsibilities
- sponsorDuties codes: 1,12,15 (15: 'Atezolizumab PK, immunogenicity, Receive local laboratory results without processing samples'),2,5
Third parties
- {"country":"Ireland","full_name":"Icon Clinical Research Limited","duties_or_roles":"sponsorDuties codes: 1,12,15 (15: 'Atezolizumab PK, immunogenicity, Receive local laboratory results without processing samples'),2,5","organisation_type":"Pharmaceutical company"}
Investigational products
- Investigational Product Name
- CABOMETYX 60 mg film-coated tablets
- Active Substance
- Cabozantinib
- Modality
- Small molecule
- Routes Of Administration
- Oral use
- Route
- Oral
- Authorisation Status
- Authorised (EU marketing authorisation EU/1/16/1136/006)
- Dose Levels
- 60 mg
- Maximum Dose
- 60.00 mg (maxDailyDoseAmount reported for this product)
- Investigational Product Name
- CABOMETYX 20 mg film-coated tablets
- Active Substance
- Cabozantinib
- Modality
- Small molecule
- Routes Of Administration
- Oral use
- Route
- Oral
- Authorisation Status
- Authorised (EU marketing authorisation EU/1/16/1136/002)
- Dose Levels
- 20 mg
- Maximum Dose
- 40.00 mg (maxDailyDoseAmount reported for this product)
- Investigational Product Name
- Tecentriq 1 200 mg concentrate for solution for infusion
- Active Substance
- Atezolizumab
- Modality
- Monoclonal antibody
- Routes Of Administration
- Intravenous use
- Route
- Intravenous
- Authorisation Status
- Authorised (EU marketing authorisation EU/1/17/1220/001)
- Dose Levels
- Concentrate for solution for infusion (1200 mg vial)
- Maximum Dose
- Concentration 60.00 mg/ml (as reported)
- Investigational Product Name
- Nexavar 200 mg film-coated tablets
- Active Substance
- Sorafenib
- Modality
- Small molecule
- Routes Of Administration
- Oral use
- Route
- Oral
- Authorisation Status
- Authorised (EU marketing authorisation EU/1/06/342/001)
- Orphan Designation
- Yes
- Dose Levels
- 200 mg tablets
- Maximum Dose
- 800.00 mg (maxDailyDoseAmount reported)
- Combination Treatment
- Yes
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