Phase 2
N=137
A Phase II Open Label Study of BMS-582664 in Locally Advanced or Metastatic Hepatocellular Cancer
Hepatocellular Carcinoma (HCC)
Bottom Line
View on ClinicalTrials.gov: NCT00355238 ↗Enrolled (actual)
137
Serious AEs
39.2%
Results posted
Dec 2023
Primary outcome: Primary: Progression Free Survival (PFS) Rate at 6 Months Per Independent Response Review Committee (IRRC) in Cohort A — 22.4 Percent of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- brivanib (active) (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Bristol-Myers Squibb
- Primary completion
- Apr 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression Free Survival (PFS) Rate at 6 Months Per Independent Response Review Committee (IRRC) in Cohort A |
22.4 | — |
| PRIMARY The Number of Participants Experiencing Adverse Events (AEs) |
54; 46; 22 | — |
| SECONDARY Tumor Response Rate Per Independent Response Review Committee (IRRC) |
7.3; 4.3; 0.0 | — |
| SECONDARY Disease Control Rate Per Independent Response Review Committee (IRRC) |
50.9; 45.7; 54.5 | — |
| SECONDARY Overall Survival for Participants With No Prior Systemic Therapy |
9.95 | — |
| SECONDARY Overall Survival for Participants With One Prior Angiogenesis Inhibitor Therapy |
9.79; 8.25 | — |
| SECONDARY Progression Free Survival (PFS) Per Independent Response Review Committee (IRRC) |
2.69; 2.0; 2.96 | — |
| SECONDARY Time to Response Per Independent Response Review Committee (IRRC) |
10.4; 1.4 | — |
| SECONDARY Duration of Response Per Independent Response Review Committee (IRRC) |
2.9; 4.2 | — |
| SECONDARY Change From Baseline to End of Treatment in FHSI-8 Total Score |
-4.01; -2.40; -1.06 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- Diagnosis of hepatocellular carcinoma (HCC) ≥ 2cm based on:
- Biopsy OR
- Radiological evidence of HCC by contrast-enhanced CT scan or contrast-enhanced AND
- Blood test positive for Hepatitis B or C AND
- Alpha fetoprotein above > 400 mg/L
- Not appropriate for curative surgery
- Screening Blood Pressure 50%
Exclusion Criteria
- Heart Attack within 12 months, uncontrolled chest pain within 6 months
- Ascites resistant to diuretic medication therapy
- Portal-systemic encephalopathy
- Portal hypertension with bleeding esophageal or gastric varices within the past 2 months
- Deficiency of sodium in the blood with sodium < 125 mEq/L
- Subjects with serious non-healing wounds, ulcers or bone fractures
Data sourced from ClinicalTrials.gov (NCT00355238). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.