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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
137
Tablet, Oral, Brivanib 800 mg, once daily, until progression
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.
Time frame: 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.
Time frame: From first dose up to 30 days post last dose (up to approximately 34 months)
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.
Time frame: 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)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
City Of Hope National Medical Center
Duarte, California, United States
City Of Hope National Medical Center
Duarte, California, United States
Harbor UCLA Medical Center
Los Angeles, California, United States
Harbor-Ucla Medical Center
Los Angeles, California, United States
Christiana Care Health Services
Newark, Delaware, United States
University Of Miami Miller School Of Medicine
Miami, Florida, United States
Northwestern University Feinberg School Of Medicine
Chicago, Illinois, United States
University Of Chicago
Chicago, Illinois, United States
University Of Iowa Hospitals And Clinics
Iowa City, Iowa, United States
Wayne State University
Detroit, Michigan, United States
...and 27 more locations
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline and end of treatment (up to approximately 33 months)