Status:
TERMINATED
HCV-RNA Kinetics During Sorafenib for Hepatocellular Carcinoma (HCC)
Lead Sponsor:
Massachusetts General Hospital
Conditions:
Hepatocellular Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
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 ca...
Detailed Description
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 So...
Eligibility Criteria
Inclusion
- Histologically and/or radiologically confirmed advanced HCC
- Detectable HCV RNA with anti-HCV-positivity
- Life expectancy of at least 3 months
- Willing to use adequate contraception
Exclusion
- Pregnant or breastfeeding
- Undetectable HCV RNA
- Uncontrolled hypertension
- Active or clinically significant cardiac disease
- Thrombolic, embolic, venous or arterial events within 6 months of informed consent
- Pulmonary hemorrhage/bleeding event (NCI-CTCAE grade 2 or higher) within 4 weeks before study entry
- Previously untreated or concurrent cancer except cervical cancer in situ, treated basal cell carcinoma or superficial bladder tumor
- Presence of non-healing wound, ulcer or bone fracture
- History of organ allograft
- Known or suspected allergy or hypersensitivity to any of the study drugs
- Any malabsorption condition
- Inability to comply with the protocol and/or not willing or not available for follow up
- Major surgery within 30 days prior to start of study drug
Key Trial Info
Start Date :
May 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2017
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT01849588
Start Date
May 1 2013
End Date
January 1 2017
Last Update
April 19 2017
Active Locations (3)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02214
2
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02215
3
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215