Advanced Hepatocellular CarcinomaPhase 2NCT00517920
Phase 2 Study of ABT-869 in Advanced Hepatocellular Carcinoma (HCC)
A Phase 2 study testing ABT-869 in people with Advanced Hepatocellular Carcinoma, run by AbbVie (prior sponsor, Abbott) at 6 sites in 4 countries.
Trial summary
Phase 2 Study of ABT-869 in Advanced Hepatocellular Carcinoma (HCC) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Hepatocellular Carcinoma
- What is being tested?
- ABT-869
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 6 sitesin 4 countries
- Study dates
- Sep 2007to Jun 2012
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
6 sites in 4 countries.
6 sites in 4 countries
Canada2 sites
Site Reference ID/Investigator# 7169
Toronto, M5G 2M9
Site Reference ID/Investigator# 5837
Vancouver, V5Z 4E6
Singapore2 sites
Site Reference ID/Investigator# 5235
Singapore, 119228
Site Reference ID/Investigator# 5611
Singapore, 169610
United States1 site
Site Reference ID/Investigator# 7726
Philadelphia, Pennsylvania, 19107
About this study
Official title: An Open-Label, Phase 2 Study of Efficacy and Tolerability of ABT-869 in Advanced Hepatocellular Carcinoma (HCC)
Phase 2 Study of ABT-869 in Advanced Hepatocellular Carcinoma (HCC)
Read the detailed description
An Open-label, Phase 2 study of efficacy and tolerability of ABT-869 in advanced hepatocellular carcinoma (HCC)
- Conditions
- Advanced Hepatocellular Carcinoma
- Being tested
- ABT-869
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABT-869Drug
0.25 mg/kg QD
| Study group | Role | What they receive |
|---|---|---|
| ABT-869 | Experimental | Not described Receives: Drug: ABT-869 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-Free Rate
Measured: Week 16
Objective Response Rate
Measured: Week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2007 (estimated)
- Study startSep 2007
- Primary completionJun 2011
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Hepatocellular CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbbVie (prior sponsor, Abbott)
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Genentech, Inc.
- Responsible party
- Sponsor
- Investigators
- Justin Ricker, MD, Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00517920
- Sponsor's protocol ID
- M06-879
- Status last verified
- Jan 2013
- First submitted
- 16 Aug 2007
- Last updated
- 4 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Phase 2 Study of Efficacy and Tolerability of ABT-869 in Advanced Hepatocellular Carcinoma (HCC)
- ClinicalTrials.gov ID
- NCT00517920
- Acronym / sponsor ID
- M06-879
- Conditions
- Advanced Hepatocellular Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- AbbVie (prior sponsor, Abbott)Industry (pharma, biotech, devices)
- Collaborators
- Genentech, Inc.
- Study start
- Sep 2007
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 17 Aug 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Phase 2 Study of ABT-869 in Advanced Hepatocellular Carcinoma (HCC)
Detailed description
An Open-label, Phase 2 study of efficacy and tolerability of ABT-869 in advanced hepatocellular carcinoma (HCC)
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ABT-869 | Experimental | Drug: ABT-869 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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%
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ABT-8690.25 mg/kg QD | Drug | ABT-869 |
Primary outcome
Progression-Free Rate
Time frame: Week 16
Objective Response Rate
Time frame: Week 16
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2013.
Related trials for Advanced Hepatocellular Carcinoma
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
Not yet recruitingPhase 2
A Clinical Study Evaluating the Safety and Efficacy of Ivonescimab as Second-line Treatment in Patients With Advanced Hepatocellular Carcinoma
Hepatocellular Carcinoma (HCC), HCC - Hepatocellular Carcinoma
Active, not recruitingPhase 2
Durvalumab and Tremelimumab in Combination With Propranolol and Chemotherapy for Treatment of Advanced Hepatopancreabiliary Tumors (BLOCKED)
Pancreatic Cancer, Hepatocellular Cancer
RecruitingPhase 1/2
A Phase 1 and 2 Study of VMD-102 in Hepatocellular Carcinoma and Other Solid Tumors
Hepatocellular Carcinoma (HCC), Metastatic Uveal Melanoma
Not yet recruitingPhase 2
Study Evaluating the Efficacy and Safety of BGB-B2033 in Participants With Advanced Hepatocellular Carcinoma
Hepatocellular Cancer, Liver Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Justin Ricker, MD study director
AbbVie
6 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ABT-869 in people with Advanced Hepatocellular Carcinoma, run by AbbVie (prior sponsor, Abbott) at 6 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Canada, Singapore, United States, Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-Free Rate (time frame: Week 16). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jan 2013; AzTrials last refreshed its copy on 7 Nov 2026.