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

Advanced Hepatocellular Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00517920
• Other study ID #: M06-879
• Status: Completed
• Phase: Phase 2
• First received: August 16, 2007
• Last updated: January 2, 2013
• Start date: September 2007
• Est. completion date: June 2012

Study information

• Verified date: January 2013
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationCanada: Health CanadaTaiwan: Department of Health
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: June 2012
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Advanced Hepatocellular Carcinoma
• Carcinoma
• Carcinoma, Hepatocellular

Intervention

Drug:
• ABT-869
0.25 mg/kg QD

Locations

Country	Name	City	State
Canada	Site Reference ID/Investigator# 7169	Toronto
Canada	Site Reference ID/Investigator# 5837	Vancouver
Singapore	Site Reference ID/Investigator# 5235	Singapore
Singapore	Site Reference ID/Investigator# 5611	Singapore
Taiwan	Site Reference ID/Investigator# 6265	Taipei
United States	Site Reference ID/Investigator# 7726	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
AbbVie (prior sponsor, Abbott)	Genentech, Inc.

Countries where clinical trial is conducted

United States,  Canada,  Singapore,  Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-Free Rate		Week 16	No
Primary	Objective Response Rate		Week 16	No