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Cedazuridine

Cedazuridine is an investigational drug currently being studied in clinical trials for the treatment of various blood cancers and solid tumors. It is often used in combination with other drugs, particularly decitabine, to potentially improve outcomes for patients with conditions such as myelodysplastic syndromes (MDS), acute myeloid leukemia (AML), and metastatic prostate cancer. This article summarizes the key findings from recent clinical trials exploring the use of cedazuridine in different cancer treatments.

Table of Contents

What is Cedazuridine?

Cedazuridine is a new drug being studied for the treatment of various blood cancers and related disorders. It is often referred to by its research name ASTX727 or E7727[1]. Cedazuridine is typically used in combination with another drug called decitabine. Together, they form a medication known as decitabine/cedazuridine, which is also called INQOVI[2].

How Does Cedazuridine Work?

Cedazuridine works by slowing down how quickly the body breaks down decitabine. This allows decitabine to remain active in the body for a longer time, potentially making it more effective at treating cancer[3]. Decitabine is a type of drug that can block abnormal cells or cancer cells from growing. Together, cedazuridine and decitabine may help control the growth of cancer cells in the body.

What Conditions Does Cedazuridine Treat?

Cedazuridine, in combination with decitabine, is being studied to treat several types of blood cancers and related disorders, including:

  • Myelodysplastic Syndromes (MDS): A group of disorders where the bone marrow doesn’t produce enough healthy blood cells[1]
  • Acute Myeloid Leukemia (AML): A type of blood and bone marrow cancer[1]
  • Chronic Myelomonocytic Leukemia (CMML): A type of blood cancer that affects certain white blood cells[1]
  • Mesothelioma: A type of cancer that develops in the lining that covers the outer surface of some of the body’s organs[2]

How is Cedazuridine Given?

Cedazuridine is typically given as an oral medication (taken by mouth) in the form of tablets or capsules. It is usually taken once daily for several days as part of a treatment cycle. The exact dosing schedule can vary depending on the specific condition being treated and the individual patient’s needs[1][3].

Cedazuridine in Combination Therapies

Cedazuridine is often used in combination with other cancer drugs to potentially enhance treatment effectiveness. Some combination therapies being studied include:

  • Cedazuridine + Decitabine + Venetoclax: This combination is being studied for treating acute myeloid leukemia[4][5]
  • Cedazuridine + Decitabine + Magrolimab: This combination is being researched for myelodysplastic syndromes[6]
  • Cedazuridine + Decitabine + Enzalutamide: This combination is being studied for prostate cancer[7]

Potential Side Effects

As with all medications, cedazuridine may cause side effects. The full range of potential side effects is still being studied in clinical trials. Common side effects of cancer treatments may include fatigue, nausea, decreased blood cell counts, and increased risk of infections. It’s important to discuss potential side effects with your healthcare provider[8].

Ongoing Research

Cedazuridine is still being actively studied in clinical trials. Researchers are investigating its effectiveness in treating various types of cancer, optimal dosing schedules, and potential combinations with other drugs. If you’re interested in participating in a clinical trial involving cedazuridine, talk to your doctor about whether you might be eligible[1][2][3].

Aspect Details
Primary Uses Treatment of blood cancers (MDS, AML, CMML) and solid tumors
Combination Therapies Often combined with decitabine; also studied with enzalutamide, venetoclax, and magrolimab
Administration Oral tablets, typically given daily for 3-5 days in 28-day cycles
Key Trials NCT04256317, NCT05960773, NCT04985656, NCT05037500
Primary Outcomes Overall response rate, complete remission rate, safety and tolerability
Secondary Outcomes Progression-free survival, overall survival, duration of response, pharmacokinetics
Safety Considerations Monitoring for adverse events, dose-limiting toxicities, and effect on cardiac repolarization (QTc)
Patient Populations Adults with various blood cancers, solid tumors, and healthy volunteers for some studies

FAQ

  • What is cedazuridine and how does it work? Cedazuridine is an oral cytidine deaminase inhibitor that is often used in combination with decitabine, a chemotherapy drug. It works by blocking enzymes needed for cell growth, potentially enhancing the effectiveness of other cancer treatments.
  • Which types of cancer are being studied with cedazuridine? Clinical trials are investigating cedazuridine for various blood cancers such as myelodysplastic syndromes (MDS), acute myeloid leukemia (AML), and chronic myelomonocytic leukemia (CMML). It is also being studied for solid tumors, including metastatic prostate cancer.
  • How is cedazuridine typically administered in clinical trials? Cedazuridine is usually given orally, often in combination with decitabine. The dosing schedule varies depending on the trial, but it's commonly administered daily for 3-5 days in each 28-day treatment cycle.
  • What are some potential side effects of cedazuridine? As with any drug in clinical trials, the full side effect profile is still being studied. However, common side effects observed in cancer treatments may include fatigue, nausea, decreased blood cell counts, and increased risk of infections. The trials are closely monitoring for any adverse events.
  • Are there any promising results from cedazuridine clinical trials? While specific results vary between trials, some studies have shown promising outcomes in terms of response rates and disease control for certain blood cancers. However, it's important to note that research is ongoing, and more data is needed to fully understand the drug's efficacy and safety profile.

Ongoing Clinical Trials on Cedazuridine

  • Study Comparing Oral Azacitidine and Cedazuridine with Subcutaneous Azacitidine for Patients with Myelodysplastic Syndromes, Chronic Myelomonocytic Leukemia, or Acute Myeloid Leukemia

    Recruiting

    3 1 1 1
    Investigated diseases:
    Investigated drugs:
    Czechia France Germany Hungary Italy Poland +1

  • Study of azacitidine combined with low-dose venetoclax treatment for patients with acute myeloid leukemia

    Recruiting

    2 1 1 1
    Investigated diseases:
    Investigated drugs:
    Denmark Finland Norway Sweden

  • Title: Long-term treatment study of oral decitabine and cedazuridine combination for patients with AML, MDS, CMML, or solid tumors who previously received ASTX727

    Recruiting

    2 1 1
    Investigated diseases:
    Investigated drugs:
    Austria Bulgaria Germany Hungary Poland Romania +2

  • Study of Nivolumab, Ipilimumab, and ASTX727 for Melanoma and Lung Cancer Patients Resistant to Anti-PD-1/PD-L1 Therapy

    Recruiting

    2 1 1 1
    Investigated drugs:
    Italy

  • A study to evaluate the safety and efficacy of ivosidenib, decitabine, and cedazuridine in adults with newly diagnosed acute myeloid leukemia who are older than 60 or cannot receive intensive chemotherapy.

    Not yet recruiting

    2 1 1 1
    Investigated diseases:
    Investigated drugs:
    Spain

  • Pharmacokinetic, Safety, and Efficacy Evaluation of ASTX727 and Venetoclax in Adult Patients with Acute Myeloid Leukemia

    Not recruiting

    2 1 1 1
    Investigated diseases:
    Investigated drugs:
    Spain

  • Study of decitabine and cedazuridine combination in patients with lower-risk myelodysplastic syndromes

    Not recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Belgium Germany Spain

  • Study of Tolinapant with Decitabine and Cedazuridine for Patients with Relapsed or Refractory Peripheral T-cell Lymphoma

    Not recruiting

    1 1 1
    Investigated drugs:
    France Hungary Italy Poland Spain

  • Study of ASTX727 and Donor Lymphocyte Infusions for Patients with High-Risk Myelodysplastic Syndrome or Acute Myeloid Leukemia After Stem Cell Transplant

    Not recruiting

    2 1 1
    Investigated drugs:
    France

Glossary

  • Myelodysplastic Syndromes (MDS): A group of blood disorders where the bone marrow doesn't produce enough healthy blood cells. It can lead to anemia, infections, and bleeding problems.
  • Acute Myeloid Leukemia (AML): A type of cancer that starts in the bone marrow and quickly moves into the blood. It affects the production of normal blood cells.
  • Chronic Myelomonocytic Leukemia (CMML): A type of blood cancer that affects the production of certain white blood cells called monocytes and myeloid cells.
  • Cytidine Deaminase Inhibitor: A substance that blocks the action of cytidine deaminase, an enzyme involved in the metabolism of certain drugs and genetic material.
  • Decitabine: A chemotherapy drug used to treat certain blood cancers by interfering with the DNA of cancer cells.
  • Metastatic Castrate Resistant Prostate Cancer: An advanced form of prostate cancer that has spread to other parts of the body and no longer responds to hormone therapy.
  • Pharmacokinetics: The study of how a drug moves through the body, including its absorption, distribution, metabolism, and excretion.
  • QTc Interval: A measurement on an electrocardiogram that represents the time it takes for the heart's electrical system to recharge between beats.
  • Complete Remission (CR): The disappearance of all signs of cancer in response to treatment.
  • Overall Response Rate (ORR): The proportion of patients whose cancer shrinks or disappears after treatment.

References

  1. https://clinicaltrials.eu/trial/study-comparing-oral-azacitidine-and-cedazuridine-with-subcutaneous-azacitidine-for-patients-with-myelodysplastic-syndromes-chronic-myelomonocytic-leukemia-or-acute-myeloid-leukemia/
  2. https://clinicaltrials.gov/study/NCT05960773
  3. https://clinicaltrials.gov/study/NCT03875287
  4. https://clinicaltrials.gov/study/NCT04975919
  5. https://clinicaltrials.gov/study/NCT04746235
  6. https://clinicaltrials.gov/study/NCT05835011
  7. https://clinicaltrials.gov/study/NCT05037500
  8. https://clinicaltrials.gov/study/NCT04953923