A Phase II Study of TRC105 in Patients With Hepatocellular Carcinoma (HCC) Who Have Progressed on Sorafenib
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Enrollment
- 11
- Locations
- 1
- Primary Endpoint
- Time to Tumor Progression (TTP) for TRC105 in Hepatocellular Carcinoma (HCC).
Study Overview
Brief Summary
Background:
- TRC105 is an experimental cancer drug. It is designed to slow or stop the growth of tumors. It does this by preventing the growth of new blood vessels that feed these tumors. People with hepatocellular carcinoma (or liver cancer) sometimes do not respond to standard treatments. This includes the cancer drug sorafenib.
Objectives:
- To test the safety and effectiveness of TRC105 to treat liver cancer that has not responded to standard therapy.
Eligibility:
- People at least 18 years of age who have hepatocellular carcinoma (or liver cancer) that has not responded to standard therapy. Participants also will not be eligible for a liver transplant.
- No anticoagulation therapy is allowed with the exception of low-dose aspirin.
- No history of bleeding disorders, peptic ulcer disease or gastritis.
Design:
- Participants will have a physical exam and medical history. They will also have blood and urine tests, and imaging studies.
- Participants will receive TRC105 once a week. They will also have two daily doses of a steroid the day before each treatment. This will help prevent known side effects.
- Participants will be monitored with blood and urine tests. They will also have imaging studies every two months to study the effect of the drug on tumor growth.
- Participants will continue to have TRC105 as long as they do not have severe side effects and their liver cancer stops growing or shrinks. After stopping TRC105, they will have yearly visits with physical exams and blood tests.
Detailed Description
Background:
- Worldwide, hepatocellular carcinoma (HCC) is the fifth most common malignancy with a median survival of 6-9 months. The Study of Heart and Renal Protection (SHARP) study established Sorafenib as a standard consideration in this disease and set the bar for future studies of systemic therapy. There is no standard therapy for patients whose disease has progressed despite Sorafenib therapy.
- TRC105 is a chimeric, anti-angiogenic monoclonal antibody that binds CD105, a transmembrane receptor overexpressed by proliferating endothelial cells. TRC105 binds to CD105-expressing endothelial cells and mediates growth inhibition, apoptosis and antibody-dependent cell-mediated cytotoxicity (ADCC).
Objectives:
Primary:
-To evaluate time to tumor progression (TTP) for TRC105 in HCC.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
TRC105 in Liver Cancer
TRC105 is an experimental cancer drug designed to slow or stop the growth of tumors. It does this by preventing the growth of new blood vessels that feed these tumors. This drug is being used to test the safety and effectiveness to treat liver cancer that has not responded to standard therapy. TRC105 will be given as an intravenous infusion every two weeks.
Intervention: TRC105 (Drug)
Outcomes
Primary Outcomes
Time to Tumor Progression (TTP) for TRC105 in Hepatocellular Carcinoma (HCC).
Time Frame: 2 years
Time to tumor progression is defined as the proportion of participants who are progression free after 4 months on study. Progression is defined by the Response Evaluation Criteria in Solid Tumors (RECIST) criteria. Progression is at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5mm. (Note: the appearance of one or more new lesions is also considered progressions).
Secondary Outcomes
- Count of Participants With Adverse Events(25 months, 15 days)
Investigators
Tim Greten, M.D.
Principal Investigator
National Institutes of Health Clinical Center (CC)