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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00355238
Recruitment Status : Completed
First Posted : July 21, 2006
Last Update Posted : October 9, 2015
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Brief 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.

Condition or disease Intervention/treatment Phase
Hepatocellular Carcinoma (HCC) Drug: brivanib (active) Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 135 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Open Label Study of Brivanib (BMS582664), Administered Orally At A Dose of 800 mg Daily In Subjects With Unresectable, Locally Advanced or Metastatic Hepatocellular Carcinoma Who Have Received Either No Prior Systemic Therapy or One Prior Regimen of Angiogenesis Inhibitor Therapy
Study Start Date : December 2006
Actual Primary Completion Date : April 2010
Actual Study Completion Date : April 2010

Arm Intervention/treatment
Experimental: 1
no comparator to brivanib
Drug: brivanib (active)
Tablet, Oral, Brivanib 800 mg, once daily, until progression
Other Name: BMS-582664




Primary Outcome Measures :
  1. To estimate the 6 month progression free locally advanced or metastatic hepatocellular carcinoma (HCC) with no prior chemotherapy for HCC treated with BMS-582664. [ Time Frame: throughout the study ]

Secondary Outcome Measures :
  1. Estimate tumor response rate, time to response, duration of response, overall survival, progression free survival & disease control rate for subjects with no prior systemic therapy & for subjects with 1 prior regimen of angiogenesis inhibitor therapy. [ Time Frame: throughout the study ]
  2. To estimate the safety and tolerability for all BMS582664 (brivanib) treated patients [ Time Frame: throughout the study ]
  3. To obtain population PK, PD [ Time Frame: throughout the study ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 <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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00355238


Locations
Show Show 33 study locations
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00355238    
Other Study ID Numbers: CA182-006
First Posted: July 21, 2006    Key Record Dates
Last Update Posted: October 9, 2015
Last Verified: September 2015
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases