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

This study has been completed.
Sponsor:
Collaborator:
Genentech
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT00517920
First received: August 16, 2007
Last updated: January 2, 2013
Last verified: January 2013
History of Changes
  Purpose

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)

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)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 ClinicalTrials.gov identifier: NCT00517920

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

No publications provided

Responsible Party: AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov 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
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

ClinicalTrials.gov processed this record on May 19, 2013