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

Basic Trial Information
Trial Description
Summary
Eligibility Criteria
Trial Contact Information

Basic Trial Information

Phase
Type
Status
Age
Sponsor
Protocol IDs

Phase II

Treatment

Closed

18 and over

Pharmaceutical / Industry

M06-879
NCT00517920

Trial Description

Summary

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.

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

Trial Contact Information

Trial Lead Organizations/Sponsors

Abbott Laboratories

Genentech Incorporated

Joyce Steinberg, MD

Study Director

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00517920
Information obtained from ClinicalTrials.gov on October 10, 2008

Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.