First Line Hepato Cellular Carcinoma (HCC) (BRISK FL)
Tracking Information| Start Date ICMJE | May 2009 |
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| Estimated Primary Completion Date | February 2013 (final data collection date for primary outcome measure) |
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Current Primary Outcome Measures ICMJE
(submitted: March 9, 2009) | To compare the overall survival of brivanib versus sorafenib in subjects with advanced HCC who have not received prior systemic treatment [ Time Frame: Survival will be assessed continuously ] [ Designated as safety issue: No ] |
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| Original Primary Outcome Measures ICMJE | Same as current |
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| Change History | Complete list of historical versions of study NCT00858871 on ClinicalTrials.gov Archive Site |
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Current Secondary Outcome Measures ICMJE
(submitted: November 18, 2009) | - To compare the time to progression (TTP) (investigator assessed using modified RECIST criteria for HCC [ Time Frame: Every 6 weeks ] [ Designated as safety issue: No ]
- To compare the investigator assessed objective response rate (ORR) and disease control rate (DCR) using modified RECIST criteria for HCC [ Time Frame: Every 6 weeks ] [ Designated as safety issue: No ]
- To determine duration of response, duration of disease control, and time to response (TTR) [ Time Frame: Every 6 weeks ] [ Designated as safety issue: No ]
- To assess the safety profile of brivanib and sorafenib [ Time Frame: Every 6 weeks ] [ Designated as safety issue: Yes ]
- To explore PK and exposure-response in the study population [ Time Frame: Every 6 weeks ] [ Designated as safety issue: No ]
- To compare time to symptomatic progression [ Time Frame: Every 6 weeks ] [ Designated as safety issue: No ]
- To compare health-related quality of life [ Time Frame: Every 6 weeks ] [ Designated as safety issue: No ]
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Original Secondary Outcome Measures ICMJE
(submitted: March 9, 2009) | - To compare the time to progression (TTP) (investigator assessed using modified RECIST criteria [ Time Frame: Every 6 weeks ] [ Designated as safety issue: No ]
- To compare the investigator assessed objective response rate (ORR) and disease control rate (DCR) using modified RECIST criteria [ Time Frame: Every 6 weeks ] [ Designated as safety issue: No ]
- To determine duration of response, duration of disease control, and time to response (TTR) [ Time Frame: Every 6 weeks ] [ Designated as safety issue: No ]
- To assess the safety profile of brivanib and sorafenib [ Time Frame: Every 6 weeks ] [ Designated as safety issue: Yes ]
- To explore PK and exposure-response in the study population [ Time Frame: Every 6 weeks ] [ Designated as safety issue: No ]
- To compare time to symptomatic progression [ Time Frame: Every 6 weeks ] [ Designated as safety issue: No ]
- To compare health-related quality of life [ Time Frame: Every 6 weeks ] [ Designated as safety issue: No ]
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Descriptive Information| Brief Title ICMJE | First Line Hepato Cellular Carcinoma (HCC) |
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| Official Title ICMJE | A Randomized, Double-blind, Multi-center Phase III Study of Brivanib Versus Sorafenib as First-line Treatment in Patients With Advanced Hepatocellular Carcinoma |
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| Brief Summary | The purpose of this study is to compare the overall survival of brivanib versus sorafenib in subjects with advanced HCC who have not received prior systemic therapy. |
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| Detailed Description | |
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| Study Phase | Phase III |
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| Study Type ICMJE | Interventional |
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| Study Design ICMJE | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Efficacy Study |
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| Condition ICMJE | Hepato Cellular Carcinoma (HCC) |
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| Intervention ICMJE | - Drug: Brivanib
Tablets, Oral, 800 mg, Once Daily, Until disease progression or unacceptable toxicity Other Name: BMS-582664 - Drug: Placebo
Capsules, Oral, twice Daily, Until disease progression or unacceptable toxicity - Drug: Sorafenib
Capsules, Oral, 800 mg, twice daily, Until disease progression or unacceptable toxicity - Drug: Placebo
Tablets, Oral, Once Daily, Until disease progression or unacceptable toxicity
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| Study Arms / Comparison Groups | - Brivanib: Active Comparator
Interventions: - Drug: Brivanib
- Drug: Placebo
- Sorafenib: Active Comparator
Interventions: - Drug: Sorafenib
- Drug: Placebo
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Recruitment Information| Estimated Enrollment ICMJE | 1050 |
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| Estimated Completion Date | February 2013 |
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| Estimated Primary Completion Date | February 2013 (final data collection date for primary outcome measure) |
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| Eligibility Criteria ICMJE | Inclusion Criteria: - Histologic or cytologic confirmed diagnosis of HCC.
- Advanced HCC: disease not eligible for surgical and/or locoregional therapies OR progressive disease after surgical and/or locoregional therapies
- Child-Pugh Class A
- ECOG performance status 0-1
- Adequate hematologic, hepatic, and renal function
Exclusion Criteria: - Prior use of any systemic anti-cancer chemotherapy, immunotherapy or molecular targeted agents for HCC
- History of active cardiac disease
- Thrombotic or embolic events within the past 6 months (except HCC tumor thrombus)
- Any other hemorrhage/bleeding event >= CTCAE Grade 3 within 8 weeks except for esophageal or gastric varices
- Inability to swallow tablets or untreated malabsorption syndrome
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| Gender | Both |
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| Ages | 18 Years and older |
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| Accepts Healthy Volunteers | No |
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| Contacts ICMJE | | Contact: For participation information at a USA site use a phone number below. For site information outside the USA please email: | | Clinical.Trials@bms.com | | | Contact: First line of email MUST contain NCT# & Site#. Only trial sites that are recruiting have contact information at this time. | | | |
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| Location Countries ICMJE | United States, Argentina, Australia, Belgium, Brazil, Canada, China, Czech Republic, France, Germany, Hong Kong, India, Italy, Japan, Korea, Republic of, Mexico, Poland, Russian Federation, South Africa, Spain, Sweden, Taiwan, Thailand, Turkey, United Kingdom |
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Administrative Information| NCT ID ICMJE | NCT00858871 |
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| Responsible Party | Study Director, Bristol-Myers Squibb |
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| Study ID Numbers ICMJE | CA182-033, EUDRACT # 2008-003533-24 |
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| Study Sponsor ICMJE | Bristol-Myers Squibb |
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| Collaborators ICMJE | |
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| Investigators ICMJE | | Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb | |
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| Information Provided By | Bristol-Myers Squibb |
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