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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00517920
• Date of registration: 16/08/2007
• Prospective Registration: Yes
• Primary sponsor: AbbVie (prior sponsor, Abbott)
• Public title: Phase 2 Study of ABT-869 in Advanced Hepatocellular Carcinoma (HCC)
• Scientific title: An Open-Label, Phase 2 Study of Efficacy and Tolerability of ABT-869 in Advanced Hepatocellular Carcinoma (HCC)
• Date of first enrolment: September 2007
• Target sample size: 44
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00517920
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 2

Countries of recruitment

Canada, China, Hong Kong, Singapore, Taiwan, United States

Contacts

• Name: Justin Ricker, MD
• Affiliation: AbbVie

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Advanced Hepatocellular Carcinoma

Intervention(s)

Drug: ABT-869

Primary Outcome(s)

Objective Response Rate [Time Frame: Week 16]

Progression-Free Rate [Time Frame: Week 16]

Secondary ID(s)

M06-879

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Genentech, Inc.