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

January 2, 2013 updated by: AbbVie (prior sponsor, Abbott)

An Open-Label, Phase 2 Study of Efficacy and Tolerability of ABT-869 in Advanced Hepatocellular Carcinoma (HCC)

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

44

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
      • Toronto, Canada, M5G 2M9
        • Site Reference ID/Investigator# 7169
      • Vancouver, Canada, V5Z 4E6
        • Site Reference ID/Investigator# 5837
  • Singapore
      • Singapore, Singapore, 119228
        • Site Reference ID/Investigator# 5235
      • Singapore, Singapore, 169610
        • Site Reference ID/Investigator# 5611
  • Taiwan
      • Taipei, Taiwan, 10002
        • Site Reference ID/Investigator# 6265
  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Site Reference ID/Investigator# 7726

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ABT-869
Drug: ABT-869
0.25 mg/kg QD

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Progression-Free Rate
Time Frame: Week 16
Week 16
Objective Response Rate
Time Frame: Week 16
Week 16

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AbbVie (prior sponsor, Abbott)

Collaborators

Genentech, Inc.

Investigators

  • Study Director: Justin Ricker, MD, AbbVie

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2007

Primary Completion (Actual)

June 1, 2011

Study Completion (Actual)

June 1, 2012

Study Registration Dates

First Submitted

August 16, 2007

First Submitted That Met QC Criteria

August 16, 2007

First Posted (Estimate)

August 17, 2007

Study Record Updates

Last Update Posted (Estimate)

January 4, 2013

Last Update Submitted That Met QC Criteria

January 2, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M06-879

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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