Hepatocellular Carcinoma
Global Investigation of Therapeutic Decision in Hepatocellular Carcinoma and of its Treatment with sorafenib
Enrollment Status: OPEN
Primary Objective
The primary objective of this international non-interventional surveillance study is to evaluate the safety of Nexavar® in all patients with unresectable HCC who are candidates for systemic therapy and in whom a decision to treat with Nexavar has been made under real-life practice conditions and in a variety of patient subsets regionally and globally.
Study Design
- This study is an international prospective, open-label, multi-center, non-interventional study.
- Patients enrolled in this study must have unresectable HCC who are candidates for systemic therapy and in whom a decision to treat with Nexavar® has been made.
- The observation period for each patient is the time from the start of therapy with Nexavar® to withdrawal of consent, death, or the last visit.
- This non-interventional study will use paper and electronic versions of the CRF.
- In this international study, data will be collected for approximately 3,000 patients globally over 5 years.
Main Inclusion Criteria
- Outpatients with histologically/cytologically documented or radiographically diagnosed unresectable HCC who are candidates for systemic therapy and for whom a decision to treat with Nexavar® has been made.
Main Exclusion Criteria
Exclusion criteria must follow the approved local product information.
Costs for the Patient
There is no study-related cost to the patient.
Contact persons
Sherry Fu (734) 647-3635 (sherryfu@umich.edu)
Carrie Manwaring (734-763-7997 (cmanwar@umich.edu)
Jorge Marrero, MD jmarrero@umich.edu
A randomized, double-blind, multi-center phase III study of brivanib versus sorafenib as first-line treatment in patients with advanced hepatocellular carcinoma (The BRISK FL Study)
Enrollment Status: OPEN
Primary Objective
The main purpose of this study is to determine if patients who have liver cancer and have not received prior systemic treatment for their liver cancer live longer when given the investigational drug brivanib alaninate (also known as brivanib) compared to those who receive sorafenib (Nexavar®).
Study Design
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This is a multi-center, double-blinded, randomized, Phase III study in subjects with advanced hepatocellular carcinoma (HCC).
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After screening for eligibility and signing of informed consent, qualifed subjects will be randomized in a 1:1 ratio to receive brivanib (arm A) or sorafenib (arm B).
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Subjects randomized to treatment arm A will take orally brivanib 800 mg once daily and sorafenib matched placebo twice daily.
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Subjects randomized to treatment arm B will take orally sorafenib 400 mg twice daily and brivanib matched placebo once daily.
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Treatment assignment will remain blinded throughout the study.
Main Inclusion Criteria
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Advanced HCC patient age 18 or order with histological/cytologic confirmation and has at least one measurable untreated lesion. The patient is not eligible for or after surgical and / or locoer-gional therapies with current ECOG performance status 0-1 and Child-Pugh Class A or B.
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Locoregional therapy must be completed at least 3 weeks prior to the baseline scan; previously treated lesions are not to be selected as target lesions.
Main Exclusion Criteria:
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Contact the study team for details.
Costs for the Patient:
All costs for study drug and study-only tests will be covered by the sponsor and provided free of charge to the patient.
Contact persons
Sherry Fu (734) 647-3635 (sherryfu@umich.edu)
Carrie Manwaring (734-763-7997 (cmanwar@umich.edu)
Jorge Marrero, MD jmarrero@umich.edu
A randomized, double-blind, multi-center phase III study of brivanib plus best supportive care (BSC) versus placebo plus BSC in subjects with advanced hepatocellular carcinoma (HCC) who have failed or are intolerant to sorafenib (The BRISK PS Study)
Enrollment Status: OPEN
Primary Objective:
The main purpose of this study is to determine if patients who have liver cancer and who have already received the drug sorafenib live longer when given the investigational drug brivanib alaninate (also known as brivanib) compared to those who receive placebo (a tablet that looks like brivanib, but has no active ingredient).
Study Design:
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This is a multicenter, double-blinded, placebo-controlled, randomized Phase III study in subjects with advanced HCC who have failed or are intolerant to sorafenib therapy.
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After screening for eligibility and signing of informed consent, qualified subjects will be randomized in a 2:1 ratio to receive brivanib plus BSC (Arm 1) or placebo plus BSC (Arm 2).
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Subjects randomized to treatment arm 1 will take orally brivanib 800 mg once daily.
-
Subjects randomized to treatment arm 2 will take orally matched placebo once daily.
-
Treatment assignments will remain blinded throughout the study.
Main Inclusion Criteria:
-
Advanced HCC patient age 18 or order with histological/cytologic confirmation and has at least one measurable untreated lesion. The patient is not eligible for or after surgical and / or locoer-gional therapies with current ECOG performance status 0-1 and Child-Pugh Class A or B with a score of 7.
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Advanced HCC defined as:
i) disease not eligible for surgical or loco-regional therapy or
ii) disease progressive after surgical or loco-regional therapy
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Patient has failed ≥ 14 days of sorafenib treatment
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Locoregional therapy must be completed at least 3 weeks prior to the baseline scan; previously treated lesions are not selected as index lesions.
Main Exclusion Criteria:
-
Contact study team for details.
Costs for the Patient:
All costs for study drug and study-only tests will be covered by the sponsor and provided free of charge to the patient.
Contact persons
Sherry Fu (734) 647-3635 (sherryfu@umich.edu)
Carrie Manwaring (734-763-7997 (cmanwar@umich.edu)
Jorge Marrero, MD jmarrero@umich.edu
