CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 11 enrolled
Drug / intervention
TRC105drug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01375569
NCT01375569Phase 2Completed

A Phase II Study of TRC105 in Patients With Hepatocellular Carcinoma (HCC) Who Have Progressed on Sorafenib

National Cancer Institute (NCI)·interventional·Posted Jun 17, 2011·Updated Jul 28, 2017

In Brief

A Phase 2 clinical trial evaluating TRC105 for Hepatocellular Carcinoma and 2 related conditions. Completed, enrolled 11 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedJun 17, 2011
Enrollment StartJun 22, 2011
Primary CompletionFeb 1, 2014
Study CompletionDec 1, 2015
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 15.0 years ago

Interventions

TRC105drug