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NCT01273155 · ClinicalTrials.gov registry record · Phase 1
Belinostat for Solid Tumors and Lymphomas in Patients With Varying Degrees of Hepatic Dysfunction
A Phase 1 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 1
- Development phase
- 72
- Enrollment target
NCT01273155: Completed Phase 1 study, sponsored by National Cancer Institute (NCI).
NCT01273155 is a Phase 1 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 72 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01273155, a Phase 1 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 72 participants
- Enrollment target
Study Summary
Background: \- Belinostat is an experimental cancer treatment drug that works by helping to turn on genes that limit cell growth and survival of cancer cells. These genes are often switched off in tumors. Belinostat has been given to patients with different types of cancer to measure its safety and effectiveness, but it has not been given in a formal trial to cancer patients who have abnormal liver function. Because belinostat is processed by the liver, its safety and effectiveness needs to be established in individuals who have abnormal liver function. Researchers are interested in comparing the effects of belinostat as a cancer treatment drug in individuals with normal and abnormal liver function. Objectives: * To test the safety and effectiveness of belinostat in individuals who have solid tumors and lymphomas and who also have abnormal liver function. * To compare the results of belinostat treatment in individuals with normal and abnormal liver function. Eligibility: * Individuals at least 18 years of age who have been diagnosed with solid tumors or lymphomas that have not responded to standard treatment. * Individuals with normal liver function and varying degrees of abnormal liver function (mild, moderate, severe) are eligible. Design: * Participants will be screened with a full medical history and physical examination, as well as blood and urine tests, and tumor imaging studies. Participants will then be divided into study groups based on their liver function. * Participants will receive belinostat in cycles of treatment. Except for cycle 1, all cycles will last 21 days. Cycle 1 will last 28 days. For cycle 1 only, participants will receive a single dose of belinostat 1 week before the regular 21-day treatment cycle starts. * In each cycle, participants will receive belinostat once a day for 5 days, and will be asked to keep a medication diary to record any side effects. * Participants will have regular clinic visits with blood and urine sample collect
Interventions
- DRUG Belinostat
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 72 participants |
| Start Date | 2011-01-10 |
| Est. Completion | 2017-10-25 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01273155
The ClinicalTrials.gov registry entry for NCT01273155 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 72 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Belinostat is the first listed.
NCT01273155 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01273155 about?
NCT01273155 is a clinical study titled "Belinostat for Solid Tumors and Lymphomas in Patients With Varying Degrees of Hepatic Dysfunction". Background: \- Belinostat is an experimental cancer treatment drug that works by helping to turn on genes that limit cell growth and survival of cancer cells. These genes are often switched off in tumors. Belinostat has been given to patients with different types of cancer to measure its safety and...
What is the current status of trial NCT01273155?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 72 participants. The study started on 2011-01-10. Estimated completion is 2017-10-25.
What interventions are being tested in trial NCT01273155?
The interventions under investigation include: Belinostat (DRUG).
Who is sponsoring clinical trial NCT01273155?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
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