Phase 2 Study of ABT-869 in Advanced Hepatocellular Carcinoma (HCC)

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. Identifier: NCT00517920
Recruitment Status : Completed
First Posted : August 17, 2007
Last Update Posted : January 4, 2013
Genentech, Inc.
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )

Brief Summary:
Phase 2 Study of ABT-869 in Advanced Hepatocellular Carcinoma (HCC)

Condition or disease Intervention/treatment Phase
Advanced Hepatocellular Carcinoma Drug: ABT-869 Phase 2

Detailed Description:
An Open-label, Phase 2 study of efficacy and tolerability of ABT-869 in advanced hepatocellular carcinoma (HCC)

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 44 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label, Phase 2 Study of Efficacy and Tolerability of ABT-869 in Advanced Hepatocellular Carcinoma (HCC)
Study Start Date : September 2007
Actual Primary Completion Date : June 2011
Actual Study Completion Date : June 2012

Arm Intervention/treatment
Experimental: ABT-869 Drug: ABT-869
0.25 mg/kg QD

Primary Outcome Measures :
  1. Progression-Free Rate [ Time Frame: Week 16 ]
  2. Objective Response Rate [ Time Frame: Week 16 ]

Information from the National Library of Medicine

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

Inclusion Criteria

  • Subject must be greater than or equal to 18 years of age
  • Subject must be diagnosed with unresectable or metastatic HCC
  • Subjects must have a measurable lesion by RECIST on CT scan in at least one site which has not received radiation
  • Subject has an Eastern Cooperative Oncology Group (ECOG) Performance status of 0-2
  • No other active malignancy within the past 5 years

Exclusion Criteria

  • Subject has received targeted VEGF/PDGF/TKI therapy. Prior Avastin is allowed
  • Subject has Child-Pugh grade Class C hepatic impairment
  • The subject has proteinuria Common Toxicity Criteria (CTC) grade > 1 as measured by routine urinalysis or 24 hour urine collection during screening assessment
  • Subject currently exhibits symptomatic or persistent, uncontrolled hypertension defined as diastolic blood pressure > 100 mmHg or systolic blood pressure > 150 mmHg. Subjects may be re-screened if blood pressure is shown to be controlled with or without intervention
  • The subject has a documented left ventricular Ejection Fraction < 50%
  • Subject is receiving therapeutic anticoagulation therapy

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 identifier (NCT number): NCT00517920

United States, Pennsylvania
Site Reference ID/Investigator# 7726
Philadelphia, Pennsylvania, United States, 19107
Site Reference ID/Investigator# 7169
Toronto, Canada, M5G 2M9
Site Reference ID/Investigator# 5837
Vancouver, Canada, V5Z 4E6
Site Reference ID/Investigator# 5235
Singapore, Singapore, 119228
Site Reference ID/Investigator# 5611
Singapore, Singapore, 169610
Site Reference ID/Investigator# 6265
Taipei, Taiwan, 10002
Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
Genentech, Inc.
Study Director: Justin Ricker, MD AbbVie

Responsible Party: AbbVie (prior sponsor, Abbott) Identifier: NCT00517920     History of Changes
Other Study ID Numbers: M06-879
First Posted: August 17, 2007    Key Record Dates
Last Update Posted: January 4, 2013
Last Verified: January 2013

Additional relevant MeSH terms:
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases