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NCT01375569 · ClinicalTrials.gov registry record · Phase 2

TRC105 for Liver Cancer That Has Not Responded to Sorafenib

A Phase 2 study of Hepatocellular Carcinoma and Carcinoma, Hepatocellular, sponsored by National Cancer Institute (NCI).

Completed
Registry status
Phase 2
Development phase
11
Enrollment target
1
Study location

NCT01375569 is a Phase 2 study of Hepatocellular Carcinoma and Carcinoma, Hepatocellular that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 11 participants, below the 257-participant average among 145 other Hepatocellular Carcinoma trials with a reported enrollment target (96% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT01375569, a Phase 2 study of Hepatocellular Carcinoma and Carcinoma, Hepatocellular, has completed, sponsored by National Cancer Institute (NCI).

COMPLETED
Registry status
Phase 2
Development phase
11 participants
Enrollment target
1
Study location

Study 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.

Interventions

  • DRUG TRC105

Study Locations (1)

Maryland

  • National Institutes of Health Clinical Center, 9000 Rockville Pike - Bethesda

Trial Details

FieldValue
Enrollment Target 11 participants
Start Date 2011-06-22
Est. Completion 2015-12-01
Phase Phase 2

Sponsor

National Cancer Institute (NCI)

3,257 total trials

What the Registry Record Tells You About NCT01375569

The ClinicalTrials.gov registry entry for NCT01375569 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 11 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 257-participant average among 145 other Hepatocellular Carcinoma trials with a reported enrollment target (96% lower). The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.

The record links to 3 conditions, with Hepatocellular Carcinoma appearing as the primary indexed condition, and to 1 intervention - of which TRC105 is the first listed.

NCT01375569 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.

Frequently Asked Questions

What is clinical trial NCT01375569 about?

NCT01375569 is a clinical study titled "TRC105 for Liver Cancer That Has Not Responded to Sorafenib". 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 ...

What is the current status of trial NCT01375569?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 11 participants. The study started on 2011-06-22. Estimated completion is 2015-12-01.

What conditions does trial NCT01375569 study?

This clinical trial studies the following conditions: Hepatocellular Carcinoma, Carcinoma, Hepatocellular, Hepatocellular Cancer.

What interventions are being tested in trial NCT01375569?

The interventions under investigation include: TRC105 (DRUG).

Who is sponsoring clinical trial NCT01375569?

This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01375569 being conducted?

This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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