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

This study is ongoing, but not recruiting participants.

First Received: August 16, 2007 Last Updated: April 20, 2009 History of Changes

Sponsors and Collaborators:	Abbott Genentech
Information provided by:	Abbott
ClinicalTrials.gov Identifier:	NCT00517920

Purpose

The primary objectives of this study are to determine the efficacy of ABT-869 using RECIST criteria and to establish the safety/tolerability profile of ABT-869 in subjects with advanced HCC. The secondary objectives of this study are to identify potential biomarkers that correlate and/or predict efficacy and toxicity in subjects with advanced or metastatic HCC.

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

Drug Information available for: ABT 869

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
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 Abbott:

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:	August 2007
Estimated Primary Completion Date:	April 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
ABT-869: Experimental	Drug: ABT-869 0.25 mg/kg

Detailed Description:

RECIST - Response Evaluation Criteria in Solid Tumors

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, California
Pacific Coast Hematology Oncology Medical Group, Inc.
Fountain Valley, California, United States, 92708
United States, Pennsylvania
Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19017
Canada, British Columbia
British Columbia Cancer Agency
Vancouver, British Columbia, Canada, V5Z 4E6
Canada, Ontario
Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9
Singapore
National University Hospital
Singapore, Singapore, 119074
National Cancer Centre
Singapore, Singapore, 169610
Taiwan
National Taiwan University Hospital
Taipei, Taiwan, 104

Sponsors and Collaborators

Abbott

Genentech

Investigators

Study Director:

Justin Ricker, MD

Abbott

More Information

No publications provided

Responsible Party:	Abbott Laboratories ( Rod Humerickhouse, MD, Global Project Head )
Study ID Numbers:	M06-879
Study First Received:	August 16, 2007
Last Updated:	April 20, 2009
ClinicalTrials.gov Identifier:	NCT00517920 History of Changes
Health Authority:	United States: Food and Drug Administration; Singapore: Health Sciences Authority

Study placed in the following topic categories:

Liver Neoplasms
Liver Diseases
Digestive System Diseases
Digestive System Neoplasms
Carcinoma, Hepatocellular

Gastrointestinal Neoplasms
Hepatocellular Carcinoma
Adenocarcinoma
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:

Liver Neoplasms
Liver Diseases
Neoplasms
Digestive System Diseases
Neoplasms by Site
Digestive System Neoplasms

Neoplasms by Histologic Type
Carcinoma, Hepatocellular
Adenocarcinoma
Neoplasms, Glandular and Epithelial
Carcinoma

ClinicalTrials.gov processed this record on May 07, 2009