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Quizartinib Dihydrochloride

Quizartinib Dihydrochloride, also known as Quizartinib, is a drug currently being studied in clinical trials for the treatment of acute myeloid leukemia (AML), particularly in patients with FLT3-ITD mutations. This article explores the ongoing research and potential benefits of Quizartinib in treating this aggressive form of blood cancer.

Table of Contents

What is Quizartinib?

Quizartinib Dihydrochloride, also known simply as Quizartinib, is a medication being developed to treat certain types of blood cancers[1]. It is classified as a selective FLT3 inhibitor, which means it targets a specific protein that is often involved in the growth of cancer cells[2].

What Condition Does Quizartinib Treat?

Quizartinib is primarily being developed to treat Acute Myeloid Leukemia (AML) with specific genetic mutations[1]. AML is a type of cancer that affects the blood and bone marrow, causing rapid growth of abnormal white blood cells. Specifically, Quizartinib targets AML with FLT3-ITD mutations. This means it’s designed for patients whose leukemia cells have a particular genetic change in the FLT3 gene[1].

The drug is being studied for use in cases where:

  • The leukemia has come back after previous treatment (relapsed AML)
  • The leukemia has not responded well to other therapies (refractory AML)

Additionally, research suggests that Quizartinib may also have potential in treating myelodysplastic syndrome (MDS), another type of blood disorder[2].

How Does Quizartinib Work?

Quizartinib works by targeting and inhibiting the FLT3 protein, which is often overactive in AML cells with the FLT3-ITD mutation. By blocking this protein, Quizartinib may help to slow down or stop the growth of these cancer cells[1].

How is Quizartinib Administered?

Quizartinib is taken orally in the form of tablets. In clinical trials, it is typically administered once daily in continuous 28-day cycles[1]. The exact dosage is determined by the treating physician based on individual patient factors.

Current Clinical Trials

Quizartinib is currently undergoing various clinical trials to evaluate its effectiveness and safety. It has been granted Fast Track Status in the US and an Orphan Drug Indication in the United States, Europe, and Asia, which highlights its potential importance in treating AML[1].

Expanded Access Program

An Expanded Access Program (EAP) is available for Quizartinib in several countries. This program allows doctors to give the medicine to eligible patients before it receives full approval from health authorities[1]. The EAP for Quizartinib includes the following key points:

  • It’s available for adult patients with relapsed or refractory FLT3-ITD mutated AML
  • Patients can receive Quizartinib if their doctor submits a request and they meet eligibility criteria
  • Treatment can continue until there’s a lack of clinical benefit or unacceptable side effects occur
  • The program is available in several countries including parts of Europe, Asia, and the United States

Bioavailability Study

A recent study was conducted to determine the absolute oral bioavailability of Quizartinib. Bioavailability refers to how much of a drug enters the bloodstream and is available to have an active effect[2]. This study involved:

  • Healthy male subjects
  • Administration of both oral and intravenous (IV) Quizartinib
  • Detailed measurements of drug concentrations in the blood over time
  • Assessment of safety and tolerability

This type of study helps researchers understand how the body processes Quizartinib, which is crucial for determining the most effective dosing strategies[2].

Aspect Details
Drug Name Quizartinib Dihydrochloride (Quizartinib)
Target Condition Acute Myeloid Leukemia (AML) with FLT3-ITD mutations
Administration Oral tablets, once daily
Clinical Trial Phase Expanded Access Program and Bioavailability Study
Key Features Selective FLT3 inhibitor, potential treatment for relapsed/refractory AML
Regulatory Status Fast Track Status (US), Orphan Drug Indication (US, Europe, Asia)
Ongoing Research Efficacy, safety, pharmacokinetics, bioavailability

FAQ

  • What is Quizartinib Dihydrochloride? Quizartinib Dihydrochloride, also called Quizartinib, is a selective FLT3 inhibitor being developed to treat acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS). It's specifically designed for patients with FLT3-ITD mutations in their AML.
  • How is Quizartinib administered? Quizartinib is administered as tablets for once daily oral consumption. The dose is recommended by the doctor and is taken in continuous 28-day cycles.
  • What type of patients are eligible for Quizartinib clinical trials? Clinical trials for Quizartinib focus on adult patients with relapsed or refractory acute myeloid leukemia (AML) who have FLT3-ITD mutations. This includes patients whose AML has returned after treatment or is resistant to other therapies.
  • What is an Expanded Access Program (EAP) for Quizartinib? An Expanded Access Program allows doctors to give Quizartinib to eligible patients before it's officially approved by health authorities. This program is available in several countries and depends on physician request, country eligibility, and local regulations.
  • What are researchers studying about Quizartinib? Researchers are studying various aspects of Quizartinib, including its effectiveness in treating AML, its safety profile, and how the body processes the drug (pharmacokinetics). They're also investigating its absolute oral bioavailability, which helps understand how much of the drug enters the bloodstream when taken orally.

Ongoing Clinical Trials on Quizartinib Dihydrochloride

  • A study comparing venetoclax, azacitidine, and quizartinib versus venetoclax and azacitidine in newly diagnosed acute myeloid leukemia patients not suitable for standard chemotherapy

    Recruiting

    3 1 1
    Investigated diseases:
    Investigated drugs:
    Spain

  • Study of Quizartinib with Chemotherapy for Adults with Newly Diagnosed FLT3-ITD Negative Acute Myeloid Leukemia

    Recruiting

    3 1 1
    Investigated drugs:
    Austria Belgium Bulgaria Croatia Czechia France +9

  • Study on the Safety and Effectiveness of Quizartinib for Children with Newly Diagnosed FLT3-ITD Positive AML and Normal NPM1

    Recruiting

    2 1 1
    Investigated diseases:
    Investigated drugs:
    Belgium Denmark Estonia Finland Iceland Latvia +6

  • Study on the Safety of Low-Dose Cytarabine or Azacitidine with Venetoclax and Quizartinib for Acute Myeloid Leukemia in Patients Aged 60+ Ineligible for Standard Chemotherapy

    Not recruiting

    1 1 1 1
    Investigated drugs:
    Spain

  • Study on the Safety and Effectiveness of Quizartinib for Children and Young Adults with Acute Myeloid Leukemia (AML)

    Not recruiting

    1 1 1
    Investigated drugs:
    Belgium Denmark France Italy The Netherlands Spain +1

Glossary

  • Acute Myeloid Leukemia (AML): A type of cancer that affects the blood and bone marrow, characterized by the rapid growth of abnormal white blood cells.
  • FLT3-ITD mutation: A genetic mutation in the FLT3 gene that can occur in some AML patients, often associated with a poorer prognosis.
  • Relapsed/Refractory: Refers to cancer that has returned after treatment (relapsed) or is resistant to treatment (refractory).
  • Bioavailability: The proportion of a drug that enters the circulation when introduced into the body and is able to have an active effect.
  • Pharmacokinetics (PK): The study of how a drug moves through the body, including its absorption, distribution, metabolism, and excretion.
  • Expanded Access Program (EAP): A program that allows patients to receive experimental treatments before they are officially approved by regulatory agencies.
  • Allogeneic hematopoietic stem cell transplantation (HSCT): A procedure where a patient receives blood-forming stem cells from a genetically similar, but not identical, donor.
  • Orphan Drug Indication: A special status given to drugs developed to treat rare diseases, which can help expedite their development and approval process.

References

  1. https://clinicaltrials.gov/study/NCT03746912
  2. https://clinicaltrials.gov/study/NCT04796831