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Clinical trialNCT01273155CompletedPhase 1Interventional

Belinostat for Solid Tumors and Lymphomas in Patients With Varying Degrees of Hepatic Dysfunction

SponsorNational Cancer Institute (NCI)Enrollment72LymphomasNeoplasms
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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 collection and imaging studies to evaluate the cancer's response to treatment. * Participants may continue to take belinostat for as long as the cancer responds to the treatment.

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

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Sites

7 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States
  • University of California, Davis

    Davis, California, United States

  • City of Hope National Medical Center

    Duarte, California, United States

  • Usc Norris Cancer Center

    Los Angeles, California, United States

  • Emory University

    Atlanta, Georgia, United States

  • National Institutes of Health Clinical Center, 9000 Rockville Pike

    Bethesda, Maryland, United States

  • Karmanos Cancer Institute

    Detroit, Michigan, United States

  • Albert Einstein College of Medicine

    The Bronx, New York, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
10 Jan 2011
Primary completion
25 Oct 2017
Completion
25 Oct 2017
Last update posted
26 Mar 2019
Registered enrollment
72
Registry id
NCT01273155

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.