CompletedPhase 2

A Phase II Open Label Study of BMS-582664 in Locally Advanced or Metastatic Hepatocellular Cancer

United States, France, Hong Kong137 participantsStarted 2006-12-31

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 \<150/100 mmHg, Left Ventricular Ejection Fraction (LVEF) \>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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Progression Free Survival (PFS) Rate at 6 Months Per Independent Response Review Committee (IRRC) in Cohort A

Timeframe: From first dose up to approximately 6 months after first dose

The Number of Participants Experiencing Adverse Events (AEs)

Timeframe: From first dose up to 30 days post last dose (up to approximately 34 months)

Trial details

NCT IDNCT00355238

SponsorBristol-Myers Squibb

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2010-04-30

Results submitted2023-11-10

View on ClinicalTrials.gov More Hepatocellular Carcinoma (HCC) trials