Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01306058 · ClinicalTrials.gov registry record · Phase 1
Sorafenib and TRC105 in Hepatocellular Cancer
A Phase 1 study of Carcinoma, Hepatocellular and Liver Neoplasms, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 1
- Development phase
- 27
- Enrollment target
- 1
- Study location
NCT01306058 is a Phase 1 study of Carcinoma, Hepatocellular and Liver Neoplasms that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 27 participants, below the 612-participant average among 27 other Carcinoma, Hepatocellular trials with a reported enrollment target (96% lower). The trial reports 1 study location across 1 state.
The verdict
NCT01306058, a Phase 1 study of Carcinoma, Hepatocellular and Liver Neoplasms, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 27 participants
- Enrollment target
- 1
- Study location
Study Summary
Background: Sorafenib is a drug that has been approved to treat kidney and liver cancer (hepatocellular carcinoma, or HCC) and has been shown to prolong survival in patients with HCC. It works by slowing the spread of cancer cells, but it does not fully prevent the cancer from growing again. Researchers are interested in combining sorafenib with the experimental drug TRC105, which has been designed to block the growth of blood vessels that lead to tumor growth, in order to determine whether this drug combination stops tumor growth and reduces tumor size better than sorafenib alone. Objectives: To determine the safety and effectiveness of the combination of sorafenib and TRC105 as a treatment for hepatocellular cancer that has not responded to other treatments. Eligibility: Individuals at least 18 years of age who have been diagnosed with hepatocellular cancer that has not responded to other treatments, and who are not considered to be candidates for liver transplantation. Patients cannot be receiving anticoagulant therapy with the exception of low dose aspirin. No history of bleeding problems or peptic ulcer disease. Design: Participants will be screened with a full medical history and physical examination, blood and urine tests, and tumor imaging studies. Participants will have a tumor biopsy or provide previously collected tumor tissue for study. An examination of the esophagus to look for problems with blood vessels will be completed in patients with a history of cirrhosis. Participants will receive sorafenib tablets twice every day, in the morning and at night, with a full glass of water. Participants will receive TRC 105 infusions once every two weeks on days 1 and 15 of a 28 day cycle. At each visit during the first cycle, participants will have a physical examination and blood tests. Participants will continue to have blood tests and a urine test every cycle to monitor the effects of treatment, including tests of kidney function. Participants will h
Conditions Studied
Interventions
- DRUG Sorafenib
- DRUG TRC 105
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center, 9000 Rockville Pike - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 27 participants |
| Start Date | 2011-02-11 |
| Est. Completion | 2017-06-09 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01306058
The ClinicalTrials.gov registry entry for NCT01306058 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 27 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 612-participant average among 27 other Carcinoma, Hepatocellular 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 5 conditions, with Carcinoma, Hepatocellular appearing as the primary indexed condition, and to 2 interventions - of which Sorafenib is the first listed.
NCT01306058 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.
Frequently Asked Questions
What is clinical trial NCT01306058 about?
NCT01306058 is a clinical study titled "Sorafenib and TRC105 in Hepatocellular Cancer". Background: Sorafenib is a drug that has been approved to treat kidney and liver cancer (hepatocellular carcinoma, or HCC) and has been shown to prolong survival in patients with HCC. It works by slowing the spread of cancer cells, but it does not fully prevent the cancer from growing again. Resear...
What is the current status of trial NCT01306058?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 27 participants. The study started on 2011-02-11. Estimated completion is 2017-06-09.
What conditions does trial NCT01306058 study?
This clinical trial studies the following conditions: Carcinoma, Hepatocellular, Liver Neoplasms, Hepatoma, Adenoma, Liver Cell, Liver Neoplasms, Experimental.
What interventions are being tested in trial NCT01306058?
The interventions under investigation include: Sorafenib (DRUG), TRC 105 (DRUG).
Who is sponsoring clinical trial NCT01306058?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01306058 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
Similar trials for Carcinoma, Hepatocellular
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
-
ABX196 in Combination With Nivolumab in Patients With Hepatocellular Carcinoma
RECRUITING · Phase 1
-
CAR-macrophages for the Treatment of HER2 Overexpressing Solid Tumors
ACTIVE NOT RECRUITING · Phase 1
-
A Study of E7386 in Combination With Other Anticancer Drug(s) in Participants With Solid Tumor
ACTIVE NOT RECRUITING · Phase 1
-
A Study of Nivolumab and Relatlimab in Combination With Bevacizumab in Advanced Liver Cancer
COMPLETED · Phase 1
-
Use of TheraSphere® Yttrium-90 Glass Microspheres for Primary and Metastatic Liver Tumors
COMPLETED · Phase 1
-
A Study Evaluating Safety, Pharmacokinetics, Pharmacodynamics, And Clinical Activity Of RO7119929 (TLR7 Agonist) In Participants With Unresectable Advanced Or Metastatic Hepatocellular Carcinoma, Biliary Tract Cancer, Or Solid Tumors With Hepatic Metastases
COMPLETED · Phase 1
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.