Trial record 1 of 2 for:
Comparison of Brivanib and Liver Cancer for Those Subjects Who Have Failed Sorafenib Treatment
Comparison of Brivanib and Best Supportive Care to Placebo for Treatment of Liver Cancer for Those Subjects Who Have Failed Sorafenib Treatment (BRISK PS)
The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2011 by Bristol-Myers Squibb.
Recruitment status was Active, not recruiting
Recruitment status was Active, not recruiting
Sponsor:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00825955
First received: January 20, 2009
Last updated: April 30, 2012
Last verified: March 2011
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Purpose
The purpose of this study is to determine if Brivanib is an effective treatment for liver cancer in patients who have failed or could not take Sorafenib
| Condition | Intervention | Phase |
|---|---|---|
|
Liver Cancer |
Drug: Brivanib Drug: Placebo |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | 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 (Brivanib Study in HCC Patients at Risk Post Sorafenib) |
Resource links provided by NLM:
Further study details as provided by Bristol-Myers Squibb:
Primary Outcome Measures:
- To compare overall survival of subjects with advanced HCC who have progressed on/after or are intolerant to Sorafenib and receive Brivanib plus best supportive care (BSC) to those receiving placebo plus BSC [ Time Frame: computerized tomography (CT)/ magnetic resonance imaging (MRI) every six weeks until progression or death ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- To compare time to progression (TTP) (Investigator assessed using modified Response Evaluation Criteria In Solid Tumors (RECIST) for HCC criteria) [ Time Frame: 35 months ] [ Designated as safety issue: No ]
- To compare the Independent Radiological Review Committee (IRRC) assessed objective response rate (ORR) and disease control rate (DCR) using modified RECIST for HCC criteria [ Time Frame: 35 months ] [ Designated as safety issue: No ]
- To assess duration of response, duration of disease control and time to response [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
- To assess safety profile of brivanib. Safety will be assessed by the number of adverse events (AEs), serious adverse events (SAEs), periodic data monitoring committee (DMC) review [ Time Frame: 35 months ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 414 |
| Study Start Date: | February 2009 |
| Estimated Study Completion Date: | September 2012 |
| Primary Completion Date: | November 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Brivanib |
Drug: Brivanib
Tablets, Oral, 800 mg, once daily, until disease progression or toxicity
Other Name: BMS-582664
|
| Placebo Comparator: Placebo |
Drug: Placebo
Tablets, Oral, 0 mg, once daily, until disease progression or toxicity
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Histologic or cytologic confirmed diagnosis of HCC
- Advanced disease defined as (i) disease not eligible for surgical or loco-regional therapy or (ii) disease progressive after surgical or loco-regional therapy
- Patient has failed ≥ 14 days of Sorafenib treatment
- Cirrhotic status of Child-Pugh Class A or B with a score of 7
- Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, 2
- Subjects who have a life expectancy of at least 8 weeks
- Adequate hematologic, hepatic, and renal function
Exclusion Criteria:
- women of childbearing potential (WOCBP) who are unwilling or unable to use an acceptable method to avoid pregnancy
- Previous or concurrent cancer that is distinct in primary site
- History of active cardiac disease
- Thrombotic or embolic events within the past 6 months
- Any other hemorrhage/bleeding event > Common Terminology Criteria for Adverse Events (CTCAE) Grade 3 within 4 weeks
- Inability to swallow tablets or untreated malabsorption syndrome
- History of human immunodeficiency virus (HIV) infection
- Prior use of systemic investigational agents for HCC (except for Sorafenib)
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00825955
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Bristol-Myers Squibb
Investigators
| Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
More Information
Additional Information:
No publications provided
| Responsible Party: | Bristol-Myers Squibb |
| ClinicalTrials.gov Identifier: | NCT00825955 History of Changes |
| Other Study ID Numbers: | CA182-034, EUDRACT #: 2008-005084-34 |
| Study First Received: | January 20, 2009 |
| Last Updated: | April 30, 2012 |
| Health Authority: | Brazil: Ministry of Health Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica Canada: Health Canada Mexico: Federal Commission for Protection Against Health Risks United States: Food and Drug Administration France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) Belgium: Federal Agency for Medicinal Products and Health Products Spain: Spanish Agency of Medicines Germany: Federal Institute for Drugs and Medical Devices Greece: National Organization of Medicines Italy: National Institute of Health Sweden: Lakemedelverket South Africa: Medicines Control Council South Africa: Department of Health Hong Kong: Department of Health Korea: Food and Drug Administration Taiwan: Department of Health Thailand: Food and Drug Administration China: Food and Drug Administration Australia: Department of Health and Ageing Therapeutic Goods Administration Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products Russia: Ministry of Health of the Russian Federation Czech Republic: State Institute for Drug Control Turkey: Ministry of Health Japan: Japanese Ministry of Health |
Additional relevant MeSH terms:
|
Liver Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Liver Diseases Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Sorafenib Carcinoma, Hepatocellular |
Digestive System Diseases Adenocarcinoma Carcinoma Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 16, 2013