Hepatocellular CarcinomaPhase 2NCT01205828
ABT-888 and Temozolomide for Liver Cancer
A Phase 2 study testing Temozolomide and ABT-888 in people with Hepatocellular Carcinoma, run by Georgetown University at 1 site in United States.
Trial summary
This study is for people with liver cancer (also called hepatocellular carcinoma, or HCC in abbreviation). The purpose of this study is to test the efficacy (effectiveness) of a new combination of drugs, ABT-888 and temozolomide for patients with liver cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- Temozolomide and ABT-888
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2010to Oct 2014
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Pathological confirmation of HCC or noninvasive criteria following AASLD guidelines
- Measurable or evaluable disease based on RECIST criteria
- Progressive disease on sorafenib or intolerance to sorafenib
- ECOG performance status 0-2
- Child Pugh Class A or B
- Adequate hepatic, bone marrow, and renal function
Who cannot join
- Prior ABT-888 or other PARP inhibitor treatment
- Anticipation of need for major surgery during the study
- Any of the following within 6 months before enrollment: myocardial infarction, severe/unstable angina, congestive heart failure, or severe pulmonary disease
- Women who are pregnant or lactating
- Women and men of child-bearing potential who are not using a reliable form of contraception
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to ABT-888 and temozolomide
- Concurrent malignancy (i.e. malignancy other than hepatocellular cancer) unless 1) the subject has been curatively treated and disease free for at least 2 years or 2) the cancer was non-melanoma skin cancer or early cervical cancer.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection (excluding active hepatitis B or C) or psychiatric illness/ social situations that would limit compliance with study requirements
Trial locations and contacts
1 site in 1 country.
United States1 site
Lombardi Comprehensive Cancer Center at Georgetown University Medical Center
Washington D.C., District of Columbia, 20007
About this study
Official title: Phase II Study of ABT-888 and Temozolomide in Patients With Advanced Hepatocellular Carcinoma (HCC) Progressing Following Sorafenib Treatment or Intolerant to Sorafenib
This study is for people with liver cancer (also called hepatocellular carcinoma, or HCC in abbreviation).
The purpose of this study is to test the efficacy (effectiveness) of a new combination of drugs, ABT-888 and temozolomide for patients with liver cancer. Temozolomide acts by damaging deoxyribonucleic acid (DNA) in rapidly dividing cells, in other words, cancer cells. ABT-888 inhibits an enzyme called "PARP" which helps to fix damaged DNA. By inhibiting this enzyme, ABT-888 prevents cancer cells from repairing the damage caused by the temozolomide and will hopefully increase the killing of cancer cells, and decrease the tumors in the body.
Read more
ABT-888 is an investigational or experimental anti-cancer agent that has not yet been approved by the Food and Drug Administration (FDA) for use in liver cancer.
This study will help find out what effects (good and bad) the combination of drugs, temozolomide and ABT-888, has on liver cancer.
This research is being done because it is not known if ABT-888 will increase the effectiveness of temozolomide in liver cancer.
Read the detailed description
Patients with hepatocellular carcinoma seen at Lombardi Cancer Center were evaluated for the eligibility of this study.
The Georgetown Lombardi Comprehensive Cancer Center was responsible for the data and safety monitoring of this trial. As this study is an investigator initiated study Phase II study utilizing a non-FDA approved drug for which the PI held the IND it was considered a high risk study which had real-time monitoring by the PI and study team and quarterly reviews by the LCCC Data and Safety Monitoring Committee (DSMC).
- Conditions
- Hepatocellular Carcinoma
- Being tested
- Temozolomide, ABT-888
- Keywords
- liver cancer, hepatocellular, temozolomide, veliparib
- Medical subject headings
- Carcinoma, Hepatocellular, Liver Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TemozolomideDrug
Also called Temodar
Temozolomide 150 mg/m2/day PO Days 1-5 every 28 days
ABT-888Drug
Also called Veliparib
ABT-888 40 mg BID PO Days 1-7 every 28 days
| Study group | Role | What they receive |
|---|---|---|
| Temozolomide and ABT-888 in HCC patients | Experimental | Temozolomide 150 mg/m2/day PO Days 1-5 every 28 days ABT-888 40 mg BID PO Days 1-7 every 28 days Receives: Drug: Temozolomide; Drug: ABT-888 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Benefit Rate
complete response at any time + partial response at any time + stable disease after 8 weeks of treatment based on RECIST Criteria
Measured: 8 weeks
Secondary outcomes (4)
Overall Survival
the number of months between a patient's enrollment and his/her date of death
Measured: 2 years
Progression Free Survival
The number of months between a patient's enrollment and his/her disease progression
Measured: 2 years
Number of Participants Who Had Grade 3 or 4 Adverse Events
Record of all toxicities graded according to the NCI CTCAE version 3.0
Measured: 6 months
Biomarker Analysis
To evaluate biological correlation with response to ABT-888 and temozolomide, including evaluation of loss of heterozygosity (LOH) of 13q, decreased expression of or mutations in BRCA-1 or -2, and a select assortment of DNA repair genes.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2010 (estimated)
- Study startAug 2010
- Primary completionOct 2014
- Study completionOct 2014
Why it stopped: Lack of efficacy
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- More trials run by Georgetown UniversityThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Georgetown University
- Sponsor type
- University, hospital or other
- Collaborators
- Abbott
- Responsible party
- Sponsor
- Investigators
- Aiwu R He, MD PhD, Principal investigator, Georgetown University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01205828
- Sponsor's protocol ID
- 2009-268
- Status last verified
- Jan 2017
- First submitted
- 18 Sep 2010
- Last updated
- 12 Feb 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Gabrielson A, Tesfaye AA, Marshall JL, Pishvaian MJ, Smaglo B, Jha R, Dorsch-Vogel K, Wang H, He AR. Phase II study of temozolomide and veliparib combination therapy for sorafenib-refractory advanced hepatocellular carcinoma. Cancer Chemother Pharmacol. 2015 Nov;76(5):1073-9. doi: 10.1007/s00280-015-2852-2. Epub 2015 Oct 8.
PubMed 26449224
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of ABT-888 and Temozolomide in Patients With Advanced Hepatocellular Carcinoma (HCC) Progressing Following Sorafenib Treatment or Intolerant to Sorafenib
- ClinicalTrials.gov ID
- NCT01205828
- Acronym / sponsor ID
- 2009-268
- Conditions
- Hepatocellular Carcinoma
- Keywords
- liver cancer, hepatocellular, temozolomide, veliparib
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of efficacy
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Georgetown UniversityUniversity, hospital or other
- Collaborators
- Abbott
- Study start
- Aug 2010
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 21 Sep 2010 (estimated)
- Results
- Posted 1 Apr 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is for people with liver cancer (also called hepatocellular carcinoma, or HCC in abbreviation).
The purpose of this study is to test the efficacy (effectiveness) of a new combination of drugs, ABT-888 and temozolomide for patients with liver cancer. Temozolomide acts by damaging deoxyribonucleic acid (DNA) in rapidly dividing cells, in other words, cancer cells. ABT-888 inhibits an enzyme called "PARP" which helps to fix damaged DNA. By inhibiting this enzyme, ABT-888 prevents cancer cells from repairing the damage caused by the temozolomide and will hopefully increase the killing of cancer cells, and decrease the tumors in the body.
ABT-888 is an investigational or experimental anti-cancer agent that has not yet been approved by the Food and Drug Administration (FDA) for use in liver cancer.
This study will help find out what effects (good and bad) the combination of drugs, temozolomide and ABT-888, has on liver cancer.
This research is being done because it is not known if ABT-888 will increase the effectiveness of temozolomide in liver cancer.
Detailed description
Patients with hepatocellular carcinoma seen at Lombardi Cancer Center were evaluated for the eligibility of this study.
The Georgetown Lombardi Comprehensive Cancer Center was responsible for the data and safety monitoring of this trial. As this study is an investigator initiated study Phase II study utilizing a non-FDA approved drug for which the PI held the IND it was considered a high risk study which had real-time monitoring by the PI and study team and quarterly reviews by the LCCC Data and Safety Monitoring Committee (DSMC).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Temozolomide and ABT-888 in HCC patients | Experimental | Drug: Temozolomide, Drug: ABT-888Temozolomide 150 mg/m2/day PO Days 1-5 every 28 days ABT-888 40 mg BID PO Days 1-7 every 28 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Pathological confirmation of HCC or noninvasive criteria following AASLD guidelines
- Measurable or evaluable disease based on RECIST criteria
- Progressive disease on sorafenib or intolerance to sorafenib
- ECOG performance status 0-2
- Child Pugh Class A or B
Key exclusion criteria (8 listed)
- Prior ABT-888 or other PARP inhibitor treatment
- Anticipation of need for major surgery during the study
- Any of the following within 6 months before enrollment: myocardial infarction, severe/unstable angina, congestive heart failure, or severe pulmonary disease
- Women who are pregnant or lactating
- Women and men of child-bearing potential who are not using a reliable form of contraception
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 |
|---|---|---|
| TemozolomideAlso: TemodarTemozolomide 150 mg/m2/day PO Days 1-5 every 28 days | Drug | Temozolomide and ABT-888 in HCC patients |
| ABT-888Also: VeliparibABT-888 40 mg BID PO Days 1-7 every 28 days | Drug | Temozolomide and ABT-888 in HCC patients |
Primary outcome
Clinical Benefit Rate
Time frame: 8 weeks
complete response at any time + partial response at any time + stable disease after 8 weeks of treatment based on RECIST Criteria
4 secondary outcomes
Overall Survival
Time frame: 2 years
Progression Free Survival
Time frame: 2 years
Number of Participants Who Had Grade 3 or 4 Adverse Events
Time frame: 6 months
Biomarker Analysis
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 26449224Gabrielson A, Tesfaye AA, Marshall JL, Pishvaian MJ, Smaglo B, Jha R, Dorsch-Vogel K, Wang H, He AR. Phase II study of temozolomide and veliparib combination therapy for sorafenib-refractory advanced hepatocellular carcinoma. Cancer Chemother Pharmacol. 2015 Nov;76(5):1073-9. doi: 10.1007/s00280-015-2852-2. Epub 2015 Oct 8.
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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.
Aiwu R He, MD PhD principal investigator
Georgetown University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Temozolomide and ABT-888 in people with Hepatocellular Carcinoma, run by Georgetown University at 1 site in United States.
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 6 inclusion and 8 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: stopped early, as of the sponsor's last update on 12 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
Yes. Results are posted in the registry (first posted 1 Apr 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Clinical Benefit Rate (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01205828, which also lists 1 linked publication.
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 12 Feb 2025.