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

Primary Purpose

Advanced Hepatocellular Carcinoma

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
ABT-869
Sponsored by
AbbVie (prior sponsor, Abbott)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Advanced Hepatocellular Carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Site Reference ID/Investigator# 7726
  • Site Reference ID/Investigator# 7169
  • Site Reference ID/Investigator# 5837
  • Site Reference ID/Investigator# 5235
  • Site Reference ID/Investigator# 5611
  • Site Reference ID/Investigator# 6265

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

ABT-869

Arm Description

Outcomes

Primary Outcome Measures

Progression-Free Rate
Objective Response Rate

Secondary Outcome Measures

Full Information

First Posted
August 16, 2007
Last Updated
January 2, 2013
Sponsor
AbbVie (prior sponsor, Abbott)
Collaborators
Genentech, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00517920
Brief Title
Phase 2 Study of ABT-869 in Advanced Hepatocellular Carcinoma (HCC)
Official Title
An Open-Label, Phase 2 Study of Efficacy and Tolerability of ABT-869 in Advanced Hepatocellular Carcinoma (HCC)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
September 2007 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
June 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AbbVie (prior sponsor, Abbott)
Collaborators
Genentech, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Phase 2 Study of ABT-869 in Advanced Hepatocellular Carcinoma (HCC)
Detailed Description
An Open-label, Phase 2 study of efficacy and tolerability of ABT-869 in advanced hepatocellular carcinoma (HCC)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Hepatocellular Carcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
44 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ABT-869
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
ABT-869
Intervention Description
0.25 mg/kg QD
Primary Outcome Measure Information:
Title
Progression-Free Rate
Time Frame
Week 16
Title
Objective Response Rate
Time Frame
Week 16

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Justin Ricker, MD
Organizational Affiliation
AbbVie
Official's Role
Study Director
Facility Information:
Facility Name
Site Reference ID/Investigator# 7726
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Site Reference ID/Investigator# 7169
City
Toronto
ZIP/Postal Code
M5G 2M9
Country
Canada
Facility Name
Site Reference ID/Investigator# 5837
City
Vancouver
ZIP/Postal Code
V5Z 4E6
Country
Canada
Facility Name
Site Reference ID/Investigator# 5235
City
Singapore
ZIP/Postal Code
119228
Country
Singapore
Facility Name
Site Reference ID/Investigator# 5611
City
Singapore
ZIP/Postal Code
169610
Country
Singapore
Facility Name
Site Reference ID/Investigator# 6265
City
Taipei
ZIP/Postal Code
10002
Country
Taiwan

12. IPD Sharing Statement

Learn more about this trial

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

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