Know Cancer

or
forgot password

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


Phase 2
18 Years
N/A
Not Enrolling
Both
Advanced Hepatocellular Carcinoma

Thank you

Trial Information

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


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

Inclusion 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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Progression-Free Rate

Outcome Time Frame:

Week 16

Safety Issue:

No

Principal Investigator

Justin Ricker, MD

Investigator Role:

Study Director

Investigator Affiliation:

AbbVie

Authority:

United States: Food and Drug Administration

Study ID:

M06-879

NCT ID:

NCT00517920

Start Date:

September 2007

Completion Date:

June 2012

Related Keywords:

  • Advanced Hepatocellular Carcinoma
  • Carcinoma
  • Carcinoma, Hepatocellular

Name

Location

Site Reference ID/Investigator# 7726Philadelphia, Pennsylvania  19107