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Belinostat

Belinostat is an investigational drug being studied in clinical trials for various types of cancer, including lymphomas, solid tumors, and blood disorders. As a histone deacetylase (HDAC) inhibitor, belinostat works by blocking enzymes involved in cancer cell growth and survival. This article summarizes key findings from clinical trials evaluating belinostat’s safety, efficacy, and optimal dosing in different patient populations.

Table of Contents

What is Belinostat?

Belinostat is an experimental cancer treatment drug that is being studied for its potential to treat various types of cancer. It is also known by its brand name Beleodaq[1] and was previously referred to as PXD101 in some clinical trials[2]. Belinostat belongs to a class of drugs called histone deacetylase (HDAC) inhibitors[3].

How Belinostat Works

Belinostat works by helping to turn on genes that limit cell growth and survival of cancer cells. In many tumors, these genes are often switched off, allowing cancer cells to grow uncontrollably. By inhibiting histone deacetylases (HDACs), which are enzymes frequently deregulated in cancer cells, Belinostat can help restore normal cell function and potentially stop or slow down cancer growth[4].

Conditions Treated with Belinostat

Belinostat is being studied for the treatment of various types of cancer, including:

  • T-cell lymphomas: Including peripheral T-cell lymphoma (PTCL) and cutaneous T-cell lymphoma (CTCL)[2]
  • B-cell lymphomas: Such as diffuse large B-cell lymphoma and Burkitt lymphoma[5]
  • Solid tumors: Various types of solid tumors that have not responded to standard treatments[1]
  • Myelodysplastic syndromes (MDS): A group of blood disorders that can lead to leukemia[3]
  • Liver cancer: Specifically, hepatocellular carcinoma that cannot be removed by surgery[6]
  • Metastatic uveal melanoma: A rare type of eye cancer that has spread to other parts of the body[7]

How Belinostat is Administered

Belinostat is typically administered as an intravenous (IV) infusion, which means it is given directly into a vein. The most common dosing schedule observed in clinical trials is:

  • Given once daily for 5 consecutive days
  • Followed by a rest period
  • This cycle is usually repeated every 21 days

The exact dose and schedule may vary depending on the specific condition being treated and the individual patient’s characteristics. For example, in some trials, patients received 1000 mg/m² of Belinostat over a 30-minute infusion on days 1-5 of a 21-day cycle[8].

Belinostat in Clinical Trials

Belinostat has been and continues to be studied in various clinical trials to determine its safety and effectiveness. These trials have included:

  • Phase I trials: To determine the safe dose and identify potential side effects[1]
  • Phase II trials: To further evaluate the drug’s effectiveness in specific types of cancer[8]
  • Combination trials: Studying Belinostat in combination with other drugs, such as Binimetinib for metastatic uveal melanoma[7]

Potential Side Effects

As with any medication, Belinostat can cause side effects. Some of the most common side effects reported in clinical trials include:

  • Nausea
  • Fatigue
  • Fever (pyrexia)
  • Anemia (low red blood cell count)
  • Vomiting
  • Thrombocytopenia (low platelet count)
  • Difficulty breathing (dyspnea)
  • Neutropenia (low white blood cell count)
  • Low potassium levels (hypokalemia)[1]

More serious side effects have also been reported, including pneumonia, blood clots, and changes in kidney function. It’s important to discuss all potential risks and side effects with your healthcare provider[1].

Special Considerations

Researchers are studying how Belinostat affects patients with different levels of liver and kidney function. This is important because Belinostat is processed by the liver, and its safety and effectiveness may be different in patients with liver or kidney problems[1][4].

Additionally, some studies are looking at how a patient’s genetic makeup might affect their response to Belinostat. For example, variations in a gene called UGT1A1 are being studied to see if they impact how patients process the drug[9].

Aspect Details
Drug Name Belinostat (also known as PXD101, Beleodaq)
Drug Class Histone deacetylase (HDAC) inhibitor
Administration Intravenous infusion, typically over 30 minutes
Common Dosing 1000 mg/m2 on days 1-5 of a 21-day cycle
Cancer Types Studied T-cell lymphomas, solid tumors, myelodysplastic syndromes, hepatocellular carcinoma, B-cell lymphomas
Key Efficacy Measures Objective response rate, progression-free survival, overall survival, duration of response
Common Side Effects Nausea, fatigue, fever, anemia, vomiting, low platelet counts, difficulty breathing
Special Populations Studies ongoing in patients with liver dysfunction to determine appropriate dosing
Biomarker Studies Some trials examining histone acetylation status and gene expression changes

FAQ

  • What types of cancer is belinostat being studied for? Belinostat is being investigated for several cancer types, including cutaneous and peripheral T-cell lymphomas, solid tumors, myelodysplastic syndromes, hepatocellular carcinoma, and aggressive B-cell non-Hodgkin's lymphoma.
  • How is belinostat administered in clinical trials? In most trials, belinostat is administered intravenously over 30 minutes on days 1-5 of a 21-day cycle. The typical dose ranges from 750-1000 mg/m2, though this may vary based on liver function and other factors.
  • What are some common side effects of belinostat? Common side effects observed in clinical trials include nausea, fatigue, fever, anemia, vomiting, low platelet counts, and difficulty breathing. The severity and frequency of side effects may vary depending on the dose and individual patient factors.
  • How is the effectiveness of belinostat measured in clinical trials? Effectiveness is typically measured by assessing tumor response using criteria like RECIST or Cheson criteria. Researchers look at metrics such as objective response rate, time to progression, duration of response, and overall survival.
  • Are there any special considerations for patients with liver problems? Yes, some trials are specifically studying belinostat in patients with varying degrees of liver dysfunction to determine appropriate dosing. Patients with moderate to severe liver impairment may receive lower doses of belinostat compared to those with normal liver function.

Ongoing Clinical Trials on Belinostat

  • Study on the Effectiveness and Safety of Belinostat and Pralatrexate with Drug Combination for Newly Diagnosed Peripheral T-Cell Lymphoma Patients

    Recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    Germany Hungary Italy Poland Spain

Glossary

  • Histone deacetylase (HDAC) inhibitor: A class of drugs that block enzymes involved in removing acetyl groups from histone proteins, which can affect gene expression and cell growth. Belinostat is an HDAC inhibitor.
  • Pharmacokinetics (PK): The study of how a drug is absorbed, distributed, metabolized, and eliminated by the body. PK studies help determine appropriate dosing and administration of medications.
  • Maximum Tolerated Dose (MTD): The highest dose of a drug that can be given without causing unacceptable side effects. Determining the MTD is an important goal of early-phase clinical trials.
  • Objective Response Rate (ORR): The proportion of patients whose cancer shrinks or disappears after treatment. ORR includes both complete and partial responses.
  • Progression-Free Survival (PFS): The length of time during and after treatment that a patient lives without their cancer getting worse.
  • RECIST criteria: Response Evaluation Criteria in Solid Tumors, a standardized method for measuring tumor response in cancer clinical trials.
  • Dose-Limiting Toxicity (DLT): Side effects severe enough to prevent further dose increases of a drug in a clinical trial.
  • Myelodysplastic Syndromes (MDS): A group of blood disorders where the bone marrow doesn't produce enough healthy blood cells.
  • Hepatocellular Carcinoma (HCC): The most common type of primary liver cancer.
  • Non-Hodgkin's Lymphoma (NHL): A type of cancer that starts in white blood cells called lymphocytes, part of the body's immune system.

References

  1. https://clinicaltrials.gov/study/NCT02679131
  2. https://clinicaltrials.gov/study/NCT00274651
  3. https://clinicaltrials.gov/study/NCT00357162
  4. https://clinicaltrials.gov/study/NCT01273155
  5. https://clinicaltrials.gov/study/NCT00303953
  6. https://clinicaltrials.gov/study/NCT00321594
  7. https://clinicaltrials.gov/study/NCT05170334
  8. https://clinicaltrials.gov/study/NCT00865969
  9. https://clinicaltrials.gov/study/NCT04184869