Not provided
Not provided
Not provided
Not provided
Not provided
Lack of efficacy
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Abbott | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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).
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Temozolomide | Drug | Temozolomide 150 mg/m2/day PO Days 1-5 every 28 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Benefit Rate | complete response at any time + partial response at any time + stable disease after 8 weeks of treatment based on RECIST Criteria | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival | the number of months between a patient's enrollment and his/her date of death | 2 years |
| Progression Free Survival | The number of months between a patient's enrollment and his/her disease progression |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Aiwu R He, MD PhD | Georgetown University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lombardi Comprehensive Cancer Center at Georgetown University Medical Center | Washington D.C. | District of Columbia | 20007 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26449224 | Derived | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | ABT-888 and Temozolomide | ABT-888 40 mg daily day 1-7/28 and temozolomide 150 mg/m2/day day 1-5/28 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Temozolomide + ABT-888 | Temozolomide and ABT-888 temozolomide + ABT-888: Temozolomide 150 mg/m2/day PO Days 1-5 every 28 days ABT-888 40 mg BID PO Days 1-7 every 28 days Patents with stable disease or continued response to therapy will be treated and followed for a total of 6 cycles (6 months). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Clinical Benefit Rate | complete response at any time + partial response at any time + stable disease after 8 weeks of treatment based on RECIST Criteria | Posted | Number | participants | 8 weeks |
|
|
6 months
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Temozolomide + ABT-888 | Temozolomide and ABT-888 temozolomide + ABT-888: Temozolomide 150 mg/m2/day PO Days 1-5 every 28 days ABT-888 40 mg BID PO Days 1-7 every 28 days Patents with stable disease or continued response to therapy will be treated and followed for a total of 6 cycles (6 months). |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| nausea, vomit | Gastrointestinal disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| fatigue | General disorders | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Aiwu Ruth He | Georgetown University Medical Center | 202-444-8642 | arh29@georgetown.edu |
Not provided
| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| D008113 | Liver Neoplasms |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077204 | Temozolomide |
| C521013 | veliparib |
| ID | Term |
|---|---|
| D003606 | Dacarbazine |
| D014226 | Triazenes |
| D009930 | Organic Chemicals |
| D007093 | Imidazoles |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ABT-888 | Drug | ABT-888 40 mg BID PO Days 1-7 every 28 days |
|
|
| 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 | 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. | 6 months |
| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
|
| Secondary | Overall Survival | the number of months between a patient's enrollment and his/her date of death | Posted | Median | 95% Confidence Interval | months | 2 years |
|
|
|
| Secondary | Progression Free Survival | The number of months between a patient's enrollment and his/her disease progression | Posted | Median | 95% Confidence Interval | months | 2 years |
|
|
|
| Secondary | Number of Participants Who Had Grade 3 or 4 Adverse Events | Record of all toxicities graded according to the NCI CTCAE version 3.0 | grade 3 or 4 adverse events | Posted | Number | participants | 6 months |
|
|
|
| Secondary | 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. | Since the treatment showed no significant efficacy against HCC, therefore study of biomarker that predict responsiveness of the treatment was not carried out. | Posted | 6 months |
|
|
| 6 |
| 16 |
| 16 |
| 16 |
| fatigue | General disorders | Non-systematic Assessment |
|
| bleeding | Gastrointestinal disorders | Non-systematic Assessment | rupture of the primary tumor |
|
| multiorgan failure | Renal and urinary disorders | Non-systematic Assessment | hepato-renal syndrome from large quantity paracentesis |
|
| platelet count decrease | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| low neutrophil | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| low lymphocyte | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| nausea, vomit | Gastrointestinal disorders | Non-systematic Assessment |
|
| diarrhea | Gastrointestinal disorders | Non-systematic Assessment |
|
| constipation | Gastrointestinal disorders | Non-systematic Assessment |
|
Not provided
| D009369 | Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |
| D001393 |
| Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |