Hepatocellular carcinoma MedDRA version: 20.0 Level: SOC Classification code 10029104 Term: Neoplasms benign, malignant and unspecified (incl cysts and polyps) System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: Cabometyx
Product Name: Cabozantinib 20mg
Product Code: XL184
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: CABOZANTINIB
CAS Number: 1140909-48-3
Current Sponsor code: XL184
Sponsors
Exelixis, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Histological or cytological diagnosis of HCC. - The subject has disease that is not amenable to a curative treatment approach (eg, transplant, surgery, ablation therapy) or locoregional therapy (eg, TACE). - Measurable disease per RECIST 1.1 as determined by the Investigator. Barcelona Clinic Liver Cancer (BCLC) stage Category B or C. - Child-Pugh Score of A. - Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 320 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 320
Exclusion criteria
Exclusion criteria: - Fibrolamellar carcinoma, sarcomatoid HCC or mixed hepatocellular cholangiocarcinoma. - 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 - Radiation therapy for bone metastasis within 2 weeks, any other radiation therapy within 8 weeks prior to randomization. - 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.. - Concomitant anticoagulation with oral anticoagulants
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to evaluate the efficacy of cabozantinib in combination with atezolizumab versus sorafenib in subjects with advanced HCC who have not received previous systemic anticancer therapy. An exploratory objective is to evaluate the single-agent activity of cabozantinib in this patient population.;Secondary Objective: Not applicable;Primary end point(s): • Duration of Progression Free Survival (PFS) per Response Evaluable Criteria in Solid Tumors version 1.1 (RECIST 1.1), by Blinded Independent Radiology Committee (BIRC) • Duration of Overall Survival (OS);Timepoint(s) of evaluation of this end point: • Duration of PFS: The primary analysis of PFS is event-driven and will be conducted after at least 241 events have been observed in the first 342 subjects that are randomized (based upon Greenwich Mean Time randomization date/time values) to the experimental (cabozantinib and atezolizumab) arm and control (sorafenib) arm. • Duration of OS: The primary analysis of OS is event-driven and will be conducted after at least 346 deaths have been observed in all subjects who are randomized to the experimental (cabozantinib plus atezolizumab) arm and control (sorafenib) arm, regardless of whether any study treatment or the correct study treatment is received. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Objective response rate (ORR) per RECIST 1.1 by BIRC;Timepoint(s) of evaluation of this end point: ORR is defined as the proportion of subjects for whom the best overall response at the time of data cutoff is a complete response (CR) or partial response (PR) as assessed by the BIRC per RECIST 1.1, which is confirmed by a subsequent visit = 28 days later. | — |
Countries
Argentina, Australia, Austria, Belgium, Brazil, Canada, China, Colombia, Czech Republic, France, Georgia, Germany, Hong Kong, Hungary, Ireland, Israel, Italy, Korea, Republic of, Mexico, Netherlands, New Zealand, Philippines, Poland, Romania, Russian Federation, Singapore, Spain, Switzerland, Taiwan, Thailand, Turkey, Ukraine, United Kingdom, United States
Contacts
Public ContactExelixis Medical Affairs
Exelixis, Inc.
Outcome results
None listed