NCT00517920

Brief Summary

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

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Sep 2007

Longer than P75 for phase_2

Geographic Reach
4 countries

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 16, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 17, 2007

Completed
15 days until next milestone

Study Start

First participant enrolled

September 1, 2007

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
Last Updated

January 4, 2013

Status Verified

January 1, 2013

Enrollment Period

3.8 years

First QC Date

August 16, 2007

Last Update Submit

January 2, 2013

Conditions

Advanced Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (2)

  • Progression-Free Rate

    Week 16

  • Objective Response Rate

    Week 16

Study Arms (1)

ABT-869

EXPERIMENTAL
Drug: ABT-869

Interventions

ABT-869DRUG

0.25 mg/kg QD

ABT-869

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Site Reference ID/Investigator# 7726

Philadelphia, Pennsylvania, 19107, United States

Location

Site Reference ID/Investigator# 7169

Toronto, M5G 2M9, Canada

Location

Site Reference ID/Investigator# 5837

Vancouver, V5Z 4E6, Canada

Location

Site Reference ID/Investigator# 5235

Singapore, 119228, Singapore

Location

Site Reference ID/Investigator# 5611

Singapore, 169610, Singapore

Location

Site Reference ID/Investigator# 6265

Taipei, 10002, Taiwan

Location

MeSH Terms

Interventions

linifanib

Study Officials

  • Justin Ricker, MD

    AbbVie

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 16, 2007

First Posted

August 17, 2007

Study Start

September 1, 2007

Primary Completion

June 1, 2011

Study Completion

June 1, 2012

Last Updated

January 4, 2013

Record last verified: 2013-01

Locations

US(1)CA(2)TW(1)SG(2)