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Slow Accrual
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This research study is a Phase IV clinical trial. Phase IV trials are used to further test and monitor the safety of a drug approved by the FDA and to see if the drug has any other indications that can be used to treat different diseases.
Sorafenib is a new drug, which is approved under the brand name Nexavar for the treatment of liver cancer. It is also currently being tested in various other cancers. Sorafenib works by slowing down and/or stopping the development of new cancer cells and new blood vessels. By slowing down and/or stopping the growth of new blood vessels around a tumor, it is believed that sorafenib prevents or slows down the growth of tumors.
The researchers of this study would like to study the effects of sorafenib on hepatitis C by drawing additional research blood samples from people infected with hepatitis C who are receiving sorafenib treatment for liver cancer. These tests will measure certain proteins in the blood (HCV-RNA) which may indicate if sorafenib has any effect on the hepatitis C virus.
This is a prospective, open-label, non-interventional trial to evaluate HCV-RNA levels during treatment with Sorafenib in patients with advanced hepatocellular carcinoma.
Participants will receive Sorafenib 400mg orally twice daily. HCV-RNA (Hepatitis C Virus - Ribonucleic Acid) levels will be measured at baseline, week 2 of sorafenib, week 4 of sorafenib, week 6 of sorafenib, week 8 of sorafenib, week 12 of sorafenib, and 2 weeks after discontinuing sorafenib. HCV-RNA levels will be measured by drawing about 2 tablespoons of blood
During the study period, tumor assessments will be done by MRI (magnetic resonance imaging) or CT (computed tomography) scans at baseline and every 8 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Arm | Experimental | Sorafenib taken orally twice per day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sorafenib | Drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Decline in HCV-RNA Level | Successful decline in HCV (hepatitis C virus)-RNA level, with success defined as a decrease of at least two logs of HCV-RNA between baseline and any subsequent measurement. | up to 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Radiological Tumor Progression | Time to radiological tumor progression is defined as the time period between enrollment and the earlier of tumor progression and death. Participants who are alive and progression-free at the date of last contact will be censored at this date. | 2 years |
| Overall Survival |
| Measure | Description | Time Frame |
|---|---|---|
| Decrease Alpha-fetoprotein(AFP) Level > 20% From the Baseline | The proportion of participants with a decrease of greater than 20% in AFP (alpha-fetoprotein) level between baseline and any subsequent measurement following treatment with sorafenib will be reported. | 2 years |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andrew Zhu, MD, PhD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02214 | United States | ||
| Brigham and Women's Hospital |
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Participants were enrolled between December 2013 and December 2015
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| ID | Title | Description |
|---|---|---|
| FG000 | Sorafenib | Sorafenib taken orally twice per day Sorafenib |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Sorafenib | Sorafenib taken orally twice per day Sorafenib |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| 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 | Decline in HCV-RNA Level | Successful decline in HCV (hepatitis C virus)-RNA level, with success defined as a decrease of at least two logs of HCV-RNA between baseline and any subsequent measurement. | Posted | Count of Participants | Participants | up to 2 years |
|
|
Participants are monitored for adverse events throughout their entire time on study. This was a maximum of 13 months.
Only events possibly, probably, or definitely related to administration of sorafenib are listed here.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Sorafenib | Sorafenib taken orally twice per day Sorafenib |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| diarrhea | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
Study was terminated early due to slow accrual, therefore a small number of participants were analyzed and the data are not statistically significant.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Andrew Zhu | Massachusetts General Hospital | 617-724-4000 | azhu@partners.org |
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| ID | Term |
|---|---|
| D008113 | Liver Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D000077157 | Sorafenib |
| ID | Term |
|---|---|
| D010671 | Phenylurea Compounds |
| D014508 | Urea |
| D000577 | Amides |
| D009930 | Organic Chemicals |
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Overall survival is defined as the time period between enrollment and the date of death. Participants who are still alive at last contact will be censored at this date. |
| 2 years |
| Boston |
| Massachusetts |
| 02215 |
| United States |
| Dana-Farber Cancer Institute | Boston | Massachusetts | 02215 | United States |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| Secondary | Time to Radiological Tumor Progression | Time to radiological tumor progression is defined as the time period between enrollment and the earlier of tumor progression and death. Participants who are alive and progression-free at the date of last contact will be censored at this date. | Study was terminated early due to slow accrual. | Posted | Mean | Full Range | months | 2 years |
|
|
|
| Secondary | Overall Survival | Overall survival is defined as the time period between enrollment and the date of death. Participants who are still alive at last contact will be censored at this date. | Posted | Mean | Full Range | months | 2 years |
|
|
|
| Other Pre-specified | Decrease Alpha-fetoprotein(AFP) Level > 20% From the Baseline | The proportion of participants with a decrease of greater than 20% in AFP (alpha-fetoprotein) level between baseline and any subsequent measurement following treatment with sorafenib will be reported. | AFP levels were not available for one participant. | Posted | Count of Participants | Participants | 2 years |
|
|
|
| 0 |
| 3 |
| 3 |
| 3 |
| fatigue | General disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| palmar-plantar erythrodysesthesia | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| nausea | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| platelet count decreased | Investigations | CTCAE (4.0) | Non-systematic Assessment |
|
| epistaxis | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Hoarseness | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| anorexia | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| erythema | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| GI bleed | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| low phosphorus | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| elevated bilirubin | Investigations | CTCAE (4.0) | Non-systematic Assessment |
|
| elevated alkaline phosphatase | Investigations | CTCAE (4.0) | Non-systematic Assessment |
|
| hypertension | Vascular disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| facial rash | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| vomiting | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| weight loss | Investigations | CTCAE (4.0) | Non-systematic Assessment |
|
| abdominal pain | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| bloating | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| anemia | Blood and lymphatic system disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| anxiety | Psychiatric disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| ascites | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| chills | General disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| dyspepsia | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| periodontal disease | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment | gum bleeding |
|
| headache | Nervous system disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| hyperglycemia | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| hyperkalemia | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| hypoalbuminemia | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| hypocalcemia | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| hypoglycemia | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| hypomagnesemia | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| hyponatremia | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| non-cardiac chest pain | General disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| pruritis | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| SGOT increased | Investigations | CTCAE (4.0) | Non-systematic Assessment |
|
| SGPT increased | Investigations | CTCAE (4.0) | Non-systematic Assessment |
|
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| D008107 |
| Liver Diseases |
| D001555 |
| Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009536 | Niacinamide |
| D009539 | Nicotinic Acids |
| D000147 | Acids, Heterocyclic |
| D006571 | Heterocyclic Compounds |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |