SELINEXOR in Combination w/Bevacizumab and Atezolizumab in Newly Diagnosed Advanced Hepatocellular Carcinoma

Part of paid clinical trials in Tampa, Florida.

Sponsor
H. Lee Moffitt Cancer Center and Research Institute
Study ID
NCT05093608
Phase
PHASE1
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Selinexor Pill — DRUG
    Selinexor 60 mg or 80 mg (oral table) will be administered once a week.
  • Bevacizumab — DRUG
    Bevacizumab will be administered at a standard dose of 15 mg/kg every 3 weeks.
  • Atezolizumab — DRUG
    Atezolizumab will be administered intravenously a standard dose of 12,000 mg every 3 weeks.

Study Details

The goal of this clinical research study is to find out if the oral drug Selinexor taken along with bevacizumab and atezolizumab is effective in treating advanced Hepatocellular Carcinoma.

Key Dates

Start date
Nov 3, 2021
Status verified
Oct 2022
Primary completion
Oct 12, 2022
Completion
Oct 12, 2022

Study Design

Enrollment
2 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Dose Level 1 - 60 mg Selinexor with Bevacizumab and Atezolizumab
    60 mg Selinexor (oral tablet) will be administered once a week continuously. Bevacizumab and atezolizumab will be administered intravenously once every 3 weeks. Each cycle length will be 21 days. On the days when Selinexor and bevacizumab/atezolizumab are given the same day, Selinexor will be administered prior to the intravenous infusions of bevacizumab and atezolizumab.
  • Experimental: Dose Level 2 - 80 mg Selinexor with Bevacizumab and Atezolizumab
    80 mg Selinexor (oral tablet) will be administered once a week continuously. Bevacizumab and atezolizumab will be administered intravenously once every 3 weeks. Each cycle length will be 21 days. On the days when Selinexor and bevacizumab/atezolizumab are given the same day, Selinexor will be administered prior to the intravenous infusions of bevacizumab and atezolizumab.

Primary Outcome Measure

Maximum Tolerated Dose [ Time Frame: Up to 24 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
Moffitt Cancer CenterTampaFlorida33612-

Find similar trials in Tampa, FL

By condition
Liver cancer
By specialty
OncologyGI oncologyHepatology
By research site
Moffitt Cancer Center· Tampa, FL

Related Studies