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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: Completed Phase 2 study of Hepatocellular Carcinoma and Carcinoma, Hepatocellular, sponsored by National Cancer Institute (NCI).
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
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
Conditions Studied
Interventions
- DRUG TRC105
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center, 9000 Rockville Pike - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 11 participants |
| Start Date | 2011-06-22 |
| Est. Completion | 2015-12-01 |
| Phase | Phase 2 |
What the finished NCT01375569 record still lists
NCT01375569 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 11 participants, a relatively small participant target, below the 257-participant average among 145 other Hepatocellular Carcinoma trials with a reported enrollment target (96% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
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Where NCT01375569's enrollment target sits among peer trials
11 140th of 145 higher than 5 of 145 other Hepatocellular Carcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Hepatocellular Carcinoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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