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The purpose of this clinical research study is to learn if BMS-582664 can shrink or slow the growth of advanced liver cancer. The safety of this treatment will also be studied.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | no comparator to brivanib |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| brivanib (active) | Drug | Tablet, Oral, Brivanib 800 mg, once daily, until progression |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival (PFS) Rate at 6 Months Per Independent Response Review Committee (IRRC) in Cohort A | The percent of participants who have not progressed or died prior to 6 months from the date of their first dose. Participants who have neither progressed nor died but had their last tumor assessment prior to 6 months will not be categorized as progression free and will not be included. Tumor response was measured by the IRRC using mWHO criteria. Progression is defined as a 25% or more increase in the sum of all index lesion areas taking as reference the smallest sum recorded at or following baseline. | From first dose up to approximately 6 months after first dose |
| The Number of Participants Experiencing Adverse Events (AEs) | An Adverse Event (AE) is defined as any new untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have to have a causal relationship with this treatment. | From first dose up to 30 days post last dose (up to approximately 34 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Tumor Response Rate Per Independent Response Review Committee (IRRC) | The percent of participants whose best overall response is a partial response (PR) or complete response (CR). Tumor measurements by CT/ MRI of the chest, abdomen and pelvis will be obtained at pre-treatment (within 28 days prior to the start of treatment) and every 6 weeks. Complete Response (CR): Disappearance of all known disease. Must be confirmed 4 or more weeks later. Partial Response (PR): A 50% or more decrease in the sum of all index lesion areas compared to the baseline sum and no unequivocal progression of existing non-index lesions. In addition, there can be no appearance of new lesions. Must be confirmed 4 or more weeks later. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| City Of Hope National Medical Center | Duarte | California | 91010-3000 | United States | ||
| City Of Hope National Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21349999 | Derived | Park JW, Finn RS, Kim JS, Karwal M, Li RK, Ismail F, Thomas M, Harris R, Baudelet C, Walters I, Raoul JL. Phase II, open-label study of brivanib as first-line therapy in patients with advanced hepatocellular carcinoma. Clin Cancer Res. 2011 Apr 1;17(7):1973-83. doi: 10.1158/1078-0432.CCR-10-2011. Epub 2011 Feb 24. |
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Cohort D data collection is not in scope of the planned primary and secondary endpoints per protocol amendment 07.
Participants who are randomized into the doxorubicin arm and cross-over to brivanib prior to or after this amendment will not be included as treated participants in Arm A, B, or C.
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| ID | Title | Description |
|---|---|---|
| FG000 | Group A (Brivanib 800 mg QD) | Participants with no prior systemic therapy receive brivanib (800 mg) daily (QD). |
| FG001 | Group B (Brivanib 800 mg QD) | Participants with one prior regimen of angiogenesis inhibitor therapy treated with brivanib (800 mg) daily (QD). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| From first dose to the date of the first documented response (up to approximately 34 months) |
| Disease Control Rate Per Independent Response Review Committee (IRRC) | The percent of participants whose best response is a partial response (PR), complete response (CR) or stable disease (SD). Complete Response (CR): Disappearance of all known disease. Must be confirmed 4 or more weeks later. Partial Response (PR): A 50% or more decrease in the sum of all index lesion areas compared to the baseline sum and no unequivocal progression of existing non-index lesions. In addition, there can be no appearance of new lesions. Must be confirmed 4 or more weeks later. Stable Disease (SD): A decrease of 50% or more or an increase of 25% or more in the sum of all index lesion areas compared to baseline cannot be established. There can be no appearance of new lesions. Documentation must occur 6 weeks (42 days) or more from the baseline determination. | From first dose to the date of the first documented response (up to approximately 34 months) |
| Overall Survival for Participants With No Prior Systemic Therapy | The time (in months) from first dosing until the date of death. For those participants who have not died, survival duration will be censored at the last date the participant was known to be alive. | From first dose to the date of death (up to approximately 34 months) |
| Overall Survival for Participants With One Prior Angiogenesis Inhibitor Therapy | The time (in months) from first dosing until the date of death. For those participants who have not died, survival duration will be censored at the last date the participant was known to be alive. | From first dose to the date of death (up to approximately 34 months) |
| Progression Free Survival (PFS) Per Independent Response Review Committee (IRRC) | The time (in months) from first dosing date to the date of progression per IRRC. Participants who die without a reported prior progression will be considered to have progressed on their date of death (as found in the BMS clinical database). Participants who did not progress or die will be censored on the date of their last tumor assessment. Participants who have only baseline tumor assessment will be censored on the first dosing date. Progression is defined as a 25% or more increase in the sum of all index lesion areas taking as reference the smallest sum recorded at or following baseline. | From first dose to the date of the first documented progression (up to approximately 34 months) |
| Time to Response Per Independent Response Review Committee (IRRC) | The time from the first dose of study therapy until measurement criteria are first met for Partial response (PR) or complete response (CR), whichever is recorded first. Complete Response (CR): Disappearance of all known disease. Must be confirmed 4 or more weeks later. Partial Response (PR): A 50% or more decrease in the sum of all index lesion areas compared to the baseline sum and no unequivocal progression of existing non-index lesions. In addition, there can be no appearance of new lesions. Must be confirmed 4 or more weeks later. | From first dose to the date of the first documented response (up to approximately 34 months) |
| Duration of Response Per Independent Response Review Committee (IRRC) | Duration of response will be computed as from time measurement criteria are met for PR or CR until the date of documented progressive disease or death. Participants who neither relapse nor die will be censored on the date of their last tumor assessment. Progression is defined as a 25% or more increase in the sum of all index lesion areas taking as reference the smallest sum recorded at or following baseline. Complete Response (CR): Disappearance of all known disease. Must be confirmed 4 or more weeks later. Partial Response (PR): A 50% or more decrease in the sum of all index lesion areas compared to the baseline sum and no unequivocal progression of existing non-index lesions. In addition, there can be no appearance of new lesions. Must be confirmed 4 or more weeks later. | From first dose to the date of documented progressive disease or death (up to approximately 34 months) |
| Change From Baseline to End of Treatment in FHSI-8 Total Score | FHSI-8 (Functional Assessment of Cancer Therapy, Hepatobiliary, Symptom Index) was used to assess HCC-related symptoms. The FHSI-8 includes eight items representing HCC-related symptoms; each symptom is rated by participants on a scale of from 0 to 4. The FHSI-8 total score ranges in value from 0 to 32, with higher scores representing fewer symptoms and lower scores representing more symptoms. | Baseline and end of treatment (up to approximately 33 months) |
| Duarte |
| California |
| 91010 |
| United States |
| Harbor UCLA Medical Center | Los Angeles | California | 90095-1678 | United States |
| Harbor-Ucla Medical Center | Los Angeles | California | 90095 | United States |
| Christiana Care Health Services | Newark | Delaware | 19713 | United States |
| University Of Miami Miller School Of Medicine | Miami | Florida | 33136 | United States |
| Northwestern University Feinberg School Of Medicine | Chicago | Illinois | 60611 | United States |
| University Of Chicago | Chicago | Illinois | 60637 | United States |
| University Of Iowa Hospitals And Clinics | Iowa City | Iowa | 52242 | United States |
| Wayne State University | Detroit | Michigan | 48201 | United States |
| Saint Louis University | St Louis | Missouri | 63104 | United States |
| The Cancer Center At Hackensack University Medical Center | Hackensack | New Jersey | 07601 | United States |
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
| Penn State Milton S. Hershey Medical Center | Hershey | Pennsylvania | 17033 | United States |
| Albert Einstein Cancer Center | Philadelphia | Pennsylvania | 19141 | United States |
| Univ Of Texas Southwestern | Dallas | Texas | 75390 | United States |
| MD Anderson Cancer Center | Houston | Texas | 77030-4009 | United States |
| Md Anderson Cancer Center | Houston | Texas | 77030 | United States |
| Medical College Of Wisconsin | Milwaukee | Wisconsin | 53226 | United States |
| Local Institution | Marseille | 13273 | France |
| Local Institution | Reims | 51092 | France |
| Local Institution | Rennes | 35042 | France |
| Local Institution | Villejuif | 94805 | France |
| Local Institution | Shatin, Nt., | Hong Kong |
| Local Institution | Kampung Baharu Nilai | Negeri Sembilan | 71800 | Malaysia |
| Local Institution | Kuala Lumpur | 56000 | Malaysia |
| Local Institution | Cebu City | 6000 | Philippines |
| Local Institution | Davao City | 8000 | Philippines |
| Local Institution | Quezon | 1102 | Philippines |
| Local Institution | Singapore | 169610 | Singapore |
| Local Institution | Singapore | 308433 | Singapore |
| Local Institution | Gyeonggi-do | 410-769 | South Korea |
| Local Institution | Seoul | 135-710 | South Korea |
| Local Institution | Seoul | 138-736 | South Korea |
| Local Institution | Seoul | 152-703 | South Korea |
| Local Institution | Tainan | 704 | Taiwan |
| Local Institution | Taipei | 112 | Taiwan |
| FG002 | Group C (400 mg BID) | Participants with one prior regimen of angiogenesis inhibitor therapy treated with brivanib (400 mg) twice daily (BID). |
| FG003 | Cohort D: Doxorubicin | All participants who received at least 1 dose of doxorubicin prior to Protocol Amendment 7. Participants treated with doxorubicin from the original protocol were allowed to cross-over to recieve brivanib alaninate after unequivocal disease progression (no cross-over was allowed for toxicity alone) providing they still met the eligibility criteria and had recovered from doxorubicin toxicities. |
| Crossed Over From Doxorubicin to Recieve Brivanib Alaninate |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Group A (Brivanib 800 mg QD) | Participants with no prior systemic therapy receive brivanib (800 mg) daily (QD). |
| BG001 | Group B (Brivanib 800 mg QD) | Participants with one prior regimen of angiogenesis inhibitor therapy treated with brivanib (800 mg) daily (QD). |
| BG002 | Group C (400 mg BID) | Participants with one prior regimen of angiogenesis inhibitor therapy treated with brivanib (400 mg) twice daily (BID). |
| BG003 | Cohort D: Doxorubicin | All participants who received at least 1 dose of doxorubicin prior to Protocol Amendment 7. Participants treated with doxorubicin from the original protocol were allowed to cross-over to recieve brivanib alaninate after unequivocal disease progression (no cross-over was allowed for toxicity alone) providing they still met the eligibility criteria and had recovered from doxorubicin toxicities. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Progression Free Survival (PFS) Rate at 6 Months Per Independent Response Review Committee (IRRC) in Cohort A | The percent of participants who have not progressed or died prior to 6 months from the date of their first dose. Participants who have neither progressed nor died but had their last tumor assessment prior to 6 months will not be categorized as progression free and will not be included. Tumor response was measured by the IRRC using mWHO criteria. Progression is defined as a 25% or more increase in the sum of all index lesion areas taking as reference the smallest sum recorded at or following baseline. | All treated participants with no prior systemic therapy (Pre-specified in Group A participants only). | Posted | Number | 95% Confidence Interval | Percent of participants | From first dose up to approximately 6 months after first dose |
|
|
| |||||||||||||||||||||||||
| Primary | The Number of Participants Experiencing Adverse Events (AEs) | An Adverse Event (AE) is defined as any new untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have to have a causal relationship with this treatment. | Pre-specified for all treated participants in group A, B, and C only | Posted | Count of Participants | Participants | From first dose up to 30 days post last dose (up to approximately 34 months) |
|
| |||||||||||||||||||||||||||
| Secondary | Tumor Response Rate Per Independent Response Review Committee (IRRC) | The percent of participants whose best overall response is a partial response (PR) or complete response (CR). Tumor measurements by CT/ MRI of the chest, abdomen and pelvis will be obtained at pre-treatment (within 28 days prior to the start of treatment) and every 6 weeks. Complete Response (CR): Disappearance of all known disease. Must be confirmed 4 or more weeks later. Partial Response (PR): A 50% or more decrease in the sum of all index lesion areas compared to the baseline sum and no unequivocal progression of existing non-index lesions. In addition, there can be no appearance of new lesions. Must be confirmed 4 or more weeks later. | Pre-specified for all treated participants in group A, B, and C only | Posted | Number | 95% Confidence Interval | Percent of participants | From first dose to the date of the first documented response (up to approximately 34 months) |
| |||||||||||||||||||||||||||
| Secondary | Disease Control Rate Per Independent Response Review Committee (IRRC) | The percent of participants whose best response is a partial response (PR), complete response (CR) or stable disease (SD). Complete Response (CR): Disappearance of all known disease. Must be confirmed 4 or more weeks later. Partial Response (PR): A 50% or more decrease in the sum of all index lesion areas compared to the baseline sum and no unequivocal progression of existing non-index lesions. In addition, there can be no appearance of new lesions. Must be confirmed 4 or more weeks later. Stable Disease (SD): A decrease of 50% or more or an increase of 25% or more in the sum of all index lesion areas compared to baseline cannot be established. There can be no appearance of new lesions. Documentation must occur 6 weeks (42 days) or more from the baseline determination. | Pre-specified for all treated participants in group A, B, and C only | Posted | Number | 95% Confidence Interval | Percent of participants | From first dose to the date of the first documented response (up to approximately 34 months) |
| |||||||||||||||||||||||||||
| Secondary | Overall Survival for Participants With No Prior Systemic Therapy | The time (in months) from first dosing until the date of death. For those participants who have not died, survival duration will be censored at the last date the participant was known to be alive. | Pre-specified for all treated participants in group A only | Posted | Median | 95% Confidence Interval | Months | From first dose to the date of death (up to approximately 34 months) |
|
| ||||||||||||||||||||||||||
| Secondary | Overall Survival for Participants With One Prior Angiogenesis Inhibitor Therapy | The time (in months) from first dosing until the date of death. For those participants who have not died, survival duration will be censored at the last date the participant was known to be alive. | Pre-specified for all treated participants in group B and C only | Posted | Median | 95% Confidence Interval | Months | From first dose to the date of death (up to approximately 34 months) |
|
| ||||||||||||||||||||||||||
| Secondary | Progression Free Survival (PFS) Per Independent Response Review Committee (IRRC) | The time (in months) from first dosing date to the date of progression per IRRC. Participants who die without a reported prior progression will be considered to have progressed on their date of death (as found in the BMS clinical database). Participants who did not progress or die will be censored on the date of their last tumor assessment. Participants who have only baseline tumor assessment will be censored on the first dosing date. Progression is defined as a 25% or more increase in the sum of all index lesion areas taking as reference the smallest sum recorded at or following baseline. | Pre-specified for all treated participants in group A, B, and C only | Posted | Median | 95% Confidence Interval | Months | From first dose to the date of the first documented progression (up to approximately 34 months) |
| |||||||||||||||||||||||||||
| Secondary | Time to Response Per Independent Response Review Committee (IRRC) | The time from the first dose of study therapy until measurement criteria are first met for Partial response (PR) or complete response (CR), whichever is recorded first. Complete Response (CR): Disappearance of all known disease. Must be confirmed 4 or more weeks later. Partial Response (PR): A 50% or more decrease in the sum of all index lesion areas compared to the baseline sum and no unequivocal progression of existing non-index lesions. In addition, there can be no appearance of new lesions. Must be confirmed 4 or more weeks later. | Pre-specified for all treated participants in group A, B, and C only whose best response is either PR or CR | Posted | Median | Full Range | Months | From first dose to the date of the first documented response (up to approximately 34 months) |
|
| ||||||||||||||||||||||||||
| Secondary | Duration of Response Per Independent Response Review Committee (IRRC) | Duration of response will be computed as from time measurement criteria are met for PR or CR until the date of documented progressive disease or death. Participants who neither relapse nor die will be censored on the date of their last tumor assessment. Progression is defined as a 25% or more increase in the sum of all index lesion areas taking as reference the smallest sum recorded at or following baseline. Complete Response (CR): Disappearance of all known disease. Must be confirmed 4 or more weeks later. Partial Response (PR): A 50% or more decrease in the sum of all index lesion areas compared to the baseline sum and no unequivocal progression of existing non-index lesions. In addition, there can be no appearance of new lesions. Must be confirmed 4 or more weeks later. | Pre-specified for all treated participants in group A, B, and C only whose best response is either PR or CR | Posted | Median | Full Range | Months | From first dose to the date of documented progressive disease or death (up to approximately 34 months) |
| |||||||||||||||||||||||||||
| Secondary | Change From Baseline to End of Treatment in FHSI-8 Total Score | FHSI-8 (Functional Assessment of Cancer Therapy, Hepatobiliary, Symptom Index) was used to assess HCC-related symptoms. The FHSI-8 includes eight items representing HCC-related symptoms; each symptom is rated by participants on a scale of from 0 to 4. The FHSI-8 total score ranges in value from 0 to 32, with higher scores representing fewer symptoms and lower scores representing more symptoms. | Pre-specified for all treated participants in group A, B, and C only with baseline and end of treatment measurements | Posted | Mean | Standard Deviation | Change from baseline in FSHI-8 score | Baseline and end of treatment (up to approximately 33 months) |
|
All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Group A (Brivanib 800 mg QD) | Participants with no prior systemic therapy receive brivanib (800 mg) daily (QD). | 39 | 55 | 24 | 55 | 54 | 55 |
| EG001 | Group B (Brivanib 800 mg QD) | Participants with one prior regimen of angiogenesis inhibitor therapy treated with brivanib (800 mg) daily (QD). | 37 | 46 | 17 | 46 | 45 | 46 |
| EG002 | Group C (400 mg BID) | Participants with one prior regimen of angiogenesis inhibitor therapy treated with brivanib (400 mg) twice daily (BID). | 13 | 22 | 5 | 22 | 22 | 22 |
| EG003 | Cohort D: Doxorubicin | All participants who received at least 1 dose of doxorubicin prior to Protocol Amendment 7. Participants treated with doxorubicin from the original protocol were allowed to cross-over to recieve brivanib alaninate after unequivocal disease progression (no cross-over was allowed for toxicity alone) providing they still met the eligibility criteria and had recovered from doxorubicin toxicities. | 4 | 14 | 5 | 14 | 14 | 14 |
| EG004 | Doxorubicin Cross-Over Participants | Participants who were randomized into the doxorubicin arm, prior to Amendment 7, and crossed-over to brivanib alaninate after disease progression (not failure of doxorubicin therapy due to toxicity alone), provided that they progressed either during doxorubicin therapy or after doxorubicin and no other therapy for HCC had been subsequently administered. | 3 | 6 | 5 | 6 | 6 | 6 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Polycythaemia | Blood and lymphatic system disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Myocardial Ischaemia | Cardiac disorders | MedDRA 14.0 | Systematic Assessment |
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| Hypothyroidism | Endocrine disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Abdominal Pain | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Abdominal Pain Upper | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Mesenteric Vein Thrombosis | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Oesophageal Varices Haemorrhage | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Rectal Haemorrhage | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 14.0 | Systematic Assessment |
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| Gait Disturbance | General disorders | MedDRA 14.0 | Systematic Assessment |
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| General Physical Health Deterioration | General disorders | MedDRA 14.0 | Systematic Assessment |
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| Mucosal Inflammation | General disorders | MedDRA 14.0 | Systematic Assessment |
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| Oedema | General disorders | MedDRA 14.0 | Systematic Assessment |
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| Oedema Peripheral | General disorders | MedDRA 14.0 | Systematic Assessment |
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| Cholecystitis Acute | Hepatobiliary disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Gallbladder Disorder | Hepatobiliary disorders | MedDRA 14.0 | Systematic Assessment |
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| Hepatic Failure | Hepatobiliary disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Hepatic Function Abnormal | Hepatobiliary disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Jaundice | Hepatobiliary disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Jaundice Hepatocellular | Hepatobiliary disorders | MedDRA 14.0 | Systematic Assessment |
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| Bacteraemia | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Biliary Tract Infection | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Clostridium Difficile Colitis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Enterocolitis Infectious | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Peritoneal Infection | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Salmonella Bacteraemia | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Subcutaneous Abscess | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
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| Ammonia Increased | Investigations | MedDRA 14.0 | Systematic Assessment |
| |
| Blood Creatinine Increased | Investigations | MedDRA 14.0 | Systematic Assessment |
| |
| Haemoglobin Decreased | Investigations | MedDRA 14.0 | Systematic Assessment |
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| International Normalised Ratio Increased | Investigations | MedDRA 14.0 | Systematic Assessment |
| |
| Neutrophil Count Decreased | Investigations | MedDRA 14.0 | Systematic Assessment |
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| Platelet Count Decreased | Investigations | MedDRA 14.0 | Systematic Assessment |
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| White Blood Cell Count Decreased | Investigations | MedDRA 14.0 | Systematic Assessment |
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| Decreased Appetite | Metabolism and nutrition disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 14.0 | Systematic Assessment |
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| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 14.0 | Systematic Assessment |
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| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Bone Pain | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Muscular Weakness | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Metastases To Central Nervous System | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | Systematic Assessment |
| |
| Metastatic Pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | Systematic Assessment |
| |
| Neoplasm Malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | Systematic Assessment |
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| Convulsion | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Encephalopathy | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
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| Hepatic Encephalopathy | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
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| Lethargy | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
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| Peripheral Sensory Neuropathy | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
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| Spinal Cord Compression | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
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| Confusional State | Psychiatric disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Nephropathy Toxic | Renal and urinary disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Renal Failure | Renal and urinary disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Renal Failure Acute | Renal and urinary disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Renal Infarct | Renal and urinary disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Pleural Effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Venous Occlusion | Vascular disorders | MedDRA 14.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Left Ventricular Hypertrophy | Cardiac disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Myocardial Infarction | Cardiac disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Sinus Bradycardia | Cardiac disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Supraventricular Extrasystoles | Cardiac disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Ventricular Arrhythmia | Cardiac disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Abdominal Discomfort | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Abdominal Distension | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Abdominal Pain | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Abdominal Pain Upper | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Dry Mouth | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Faeces Discoloured | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Gastrooesophageal Reflux Disease | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Oesophagitis | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Chest Pain | General disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Influenza Like Illness | General disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Mucosal Inflammation | General disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Oedema | General disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Oedema Peripheral | General disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Cholangitis | Hepatobiliary disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Hepatic Function Abnormal | Hepatobiliary disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Hordeolum | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Laryngitis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Upper Respiratory Tract Infection | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Alanine Aminotransferase Increased | Investigations | MedDRA 14.0 | Systematic Assessment |
| |
| Aspartate Aminotransferase Increased | Investigations | MedDRA 14.0 | Systematic Assessment |
| |
| Blood Alkaline Phosphatase Increased | Investigations | MedDRA 14.0 | Systematic Assessment |
| |
| Blood Bilirubin Increased | Investigations | MedDRA 14.0 | Systematic Assessment |
| |
| Ejection Fraction Decreased | Investigations | MedDRA 14.0 | Systematic Assessment |
| |
| Electrocardiogram St-T Change | Investigations | MedDRA 14.0 | Systematic Assessment |
| |
| Gamma-Glutamyltransferase Increased | Investigations | MedDRA 14.0 | Systematic Assessment |
| |
| Neutrophil Count Decreased | Investigations | MedDRA 14.0 | Systematic Assessment |
| |
| Platelet Count Decreased | Investigations | MedDRA 14.0 | Systematic Assessment |
| |
| Qrs Axis Abnormal | Investigations | MedDRA 14.0 | Systematic Assessment |
| |
| Weight Decreased | Investigations | MedDRA 14.0 | Systematic Assessment |
| |
| Weight Increased | Investigations | MedDRA 14.0 | Systematic Assessment |
| |
| White Blood Cell Count Decreased | Investigations | MedDRA 14.0 | Systematic Assessment |
| |
| Decreased Appetite | Metabolism and nutrition disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Flank Pain | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Muscle Spasms | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Muscular Weakness | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Musculoskeletal Chest Pain | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Musculoskeletal Pain | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Pain In Extremity | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Neuropathy Peripheral | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Peripheral Sensory Neuropathy | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Confusional State | Psychiatric disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Laryngeal Oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Pulmonary Congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Rhinitis Allergic | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Blister | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Dry Skin | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Exfoliative Rash | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Palmar-Plantar Erythrodysaesthesia Syndrome | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Venous Occlusion | Vascular disorders | MedDRA 14.0 | Systematic Assessment |
|
This study protocol was amended to discontinue the doxorubicin arm, since doxorubicin was now considered an obsolete standard of care. The protocol was amended to add a third cohort of second-line participants receiving 400-mg brivanib alaninate BID for a total daily dose of 800 mg. The analyses for both cohorts are considered exploratory.
Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Bristol-Myers Squibb Study Director | Bristol-Myers Squibb | Please email | Clinical.Trials@bms.com |
| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C509922 | brivanib |
| D015444 | Exercise |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
Not provided
Not provided
| >= 65 |
|
| Male |
|
| Black/ African American |
|
| Chinese |
|
| Korean |
|
| Malaysian |
|
| White |
|
| Native Hawaiian/ Other Pacific Islander |
|
| Counts |
|---|
| Participants |
|
|
Participants with one prior regimen of angiogenesis inhibitor therapy treated with brivanib (400 mg) twice daily (BID). |
|
|
| OG002 |
| Group C (400 mg BID) |
Participants with one prior regimen of angiogenesis inhibitor therapy treated with brivanib (400 mg) twice daily (BID). |
|
|
|
|
Participants with one prior regimen of angiogenesis inhibitor therapy treated with brivanib (400 mg) twice daily (BID).
|
|
| Participants |
|
|
|
|
|
|