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

This study has been completed.
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) ) Identifier:
First received: August 16, 2007
Last updated: January 2, 2013
Last verified: January 2013

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

Condition Intervention Phase
Advanced Hepatocellular Carcinoma
Drug: ABT-869
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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)

Resource links provided by NLM:

Further study details as provided by AbbVie:

Primary Outcome Measures:
  • Progression-Free Rate [ Time Frame: Week 16 ] [ Designated as safety issue: No ]
  • Objective Response Rate [ Time Frame: Week 16 ] [ Designated as safety issue: No ]

Enrollment: 44
Study Start Date: September 2007
Study Completion Date: June 2012
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ABT-869 Drug: ABT-869
0.25 mg/kg QD

Detailed Description:

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


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its identifier: 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)
Study Director: Justin Ricker, MD AbbVie
  More Information

No publications provided

Responsible Party: AbbVie ( AbbVie (prior sponsor, Abbott) ) Identifier: NCT00517920     History of Changes
Other Study ID Numbers: M06-879
Study First Received: August 16, 2007
Last Updated: January 2, 2013
Health Authority: United States: Food and Drug Administration
Canada: Health Canada
Taiwan: Department of Health

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 processed this record on April 17, 2014