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Dacomitinib

Dacomitinib is an oral medication being studied in clinical trials for various types of cancer, particularly non-small cell lung cancer (NSCLC). As a pan-HER inhibitor, it targets multiple proteins involved in cancer growth. This article summarizes key findings from clinical trials investigating dacomitinib’s safety, efficacy, and pharmacokinetics in different patient populations.

Table of Contents

What is Dacomitinib?

Dacomitinib is a medication used in the treatment of certain types of cancer. It is also known by other names such as PF-00299804, VIZIMPRO, and DACOPLICE[1][2]. Dacomitinib belongs to a class of drugs called kinase inhibitors, which work by blocking specific proteins that contribute to cancer growth[3].

How Dacomitinib Works

Dacomitinib is what’s known as a pan-HER inhibitor. This means it targets and blocks multiple proteins in the HER (Human Epidermal Growth Factor Receptor) family, including EGFR (Epidermal Growth Factor Receptor)[4]. These proteins are often overactive in cancer cells, causing them to grow and divide uncontrollably. By inhibiting these proteins, dacomitinib can help slow down or stop the growth of cancer cells.

Conditions Treated with Dacomitinib

Dacomitinib is primarily used to treat certain types of non-small cell lung cancer (NSCLC). Specifically, it is indicated for:

  • First-line treatment of metastatic NSCLC with specific EGFR gene mutations (exon 19 deletion or exon 21 L858R substitution mutations)[3]. Metastatic means the cancer has spread to other parts of the body.
  • Advanced NSCLC in patients who have previously been treated with chemotherapy or other targeted therapies[5].

In addition to lung cancer, dacomitinib has also been studied for use in other types of cancer, such as:

  • Advanced or metastatic squamous cell carcinoma of the penis[4]. This is a rare type of cancer that affects the skin and tissues of the penis.

How Dacomitinib is Administered

Dacomitinib is taken orally in the form of tablets. The typical dosage is:

  • 45 mg taken once daily[6]
  • It should be taken at approximately the same time each day
  • Treatment continues until the disease progresses or unacceptable side effects occur

In some cases, the dosage may be adjusted based on individual patient factors or side effects. For example, some studies have explored different dosing schedules, such as intermittent dosing (taking the medication for a few days, then having a break) to manage side effects[7].

Effectiveness of Dacomitinib

Clinical trials have shown that dacomitinib can be effective in treating certain types of NSCLC. In a large study comparing dacomitinib to another drug called gefitinib:

  • Patients taking dacomitinib had a longer progression-free survival (the time during which the cancer did not worsen) compared to those taking gefitinib[3].
  • Some patients experienced a significant reduction in tumor size (called an objective response) with dacomitinib treatment[3].

It’s important to note that the effectiveness can vary from person to person, and your doctor will consider various factors when deciding if dacomitinib is the right treatment for you.

Side Effects and Safety

Like all medications, dacomitinib can cause side effects. Some of the most common side effects include:

  • Skin-related issues: Such as rash, dry skin, and nail problems[5]
  • Diarrhea[5]
  • Mouth sores[5]
  • Decreased appetite
  • Fatigue

In some cases, these side effects can be severe. Your healthcare team will monitor you closely and may adjust your treatment if needed. They may also prescribe additional medications to help manage side effects[5].

Special Considerations

There are some important things to consider when taking dacomitinib:

  • Liver function: Dacomitinib is processed by the liver, so people with liver problems may need special monitoring or dosage adjustments[1][8].
  • Pregnancy and breastfeeding: Dacomitinib can harm an unborn baby, so it should not be used during pregnancy. It’s also not known if it passes into breast milk, so breastfeeding is not recommended while taking this medication.
  • Drug interactions: Dacomitinib can interact with other medications, so it’s important to tell your doctor about all drugs and supplements you’re taking.
  • Monitoring: Regular check-ups and tests will be needed to monitor your response to the treatment and check for side effects.

Remember, this information is general, and your experience with dacomitinib may be different. Always consult with your healthcare provider for personalized advice and information about your treatment.

Aspect Details
Main Indications Non-small cell lung cancer (NSCLC), particularly with EGFR mutations
Other Studied Cancers Penile squamous cell carcinoma, recurrent glioblastoma
Administration Oral, typically 30-45 mg daily
Key Efficacy Measures Progression-free survival, overall response rate, overall survival
Common Side Effects Skin reactions, diarrhea, fatigue
Special Populations Studied Patients with hepatic impairment, specific EGFR mutations (e.g., T790M)
Combination Studies Dacomitinib plus anlotinib for advanced NSCLC
Pharmacokinetic Assessments Studies in healthy volunteers and those with hepatic impairment

FAQ

  • What types of cancer is dacomitinib being studied for? Dacomitinib is primarily being studied for non-small cell lung cancer (NSCLC), especially in patients with EGFR mutations. It has also been investigated for other cancers like penile squamous cell carcinoma and recurrent glioblastoma.
  • How is dacomitinib administered? Dacomitinib is taken orally, usually once daily. The typical dose in clinical trials ranges from 30 mg to 45 mg per day, though some studies have explored different dosing schedules.
  • What are the main side effects of dacomitinib? Common side effects observed in clinical trials include skin reactions, diarrhea, and fatigue. The severity and frequency of side effects are closely monitored in all studies to ensure patient safety.
  • How effective is dacomitinib in treating NSCLC? Clinical trials have shown promising results for dacomitinib in NSCLC patients, particularly those with specific EGFR mutations. Measures like progression-free survival and overall response rate have been used to assess its effectiveness.
  • Are there any ongoing studies combining dacomitinib with other treatments? Yes, some clinical trials are exploring the combination of dacomitinib with other cancer treatments. For example, one study is investigating dacomitinib plus anlotinib for advanced NSCLC with EGFR mutations.

Ongoing Clinical Trials on Dacomitinib

  • Study on EGFR-Mutated Lung Cancer: Evaluating Dacomitinib, Afatinib, and Osimertinib for Patients Not Suitable for Curative Treatment

    Recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    Sweden

  • Study on the Effectiveness of Entrectinib and Other Drug Combinations for Patients with Advanced Solid Tumors, Multiple Myeloma, or Non-Hodgkin Lymphoma

    Recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    The Netherlands

  • Study on the Best Treatment Sequence for Advanced Non-Small Cell Lung Cancer with EGFR Mutations Using Dacomitinib and Osimertinib

    Not yet recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Italy Spain

Glossary

  • Dacomitinib: An oral medication that belongs to a class of drugs called pan-HER inhibitors, which target multiple proteins involved in cancer cell growth and survival.
  • EGFR: Epidermal Growth Factor Receptor, a protein found on the surface of some cells that can contribute to cancer growth when mutated or overactive.
  • Non-small cell lung cancer (NSCLC): A type of lung cancer that is the most common form of the disease, accounting for about 80-85% of all lung cancers.
  • Pharmacokinetics: The study of how a drug is absorbed, distributed, metabolized, and eliminated by the body.
  • Progression-free survival (PFS): The length of time during and after treatment that a patient lives with cancer without it worsening.
  • Overall response rate (ORR): The proportion of patients whose cancer shrinks or disappears after treatment.
  • Adverse event: Any unfavorable and unintended sign, symptom, or disease temporarily associated with the use of a medical treatment or procedure.
  • T790M mutation: A specific mutation in the EGFR gene that can cause resistance to some EGFR-targeted therapies in lung cancer.
  • Pan-HER inhibitor: A type of drug that blocks multiple members of the HER (human epidermal growth factor receptor) family of proteins.
  • Hepatic impairment: Reduced function of the liver, which can affect how drugs are processed and eliminated from the body.

References

  1. https://clinicaltrials.gov/study/NCT03865446
  2. https://clinicaltrials.gov/study/NCT04511533
  3. https://clinicaltrials.gov/study/NCT01774721
  4. https://clinicaltrials.gov/study/NCT01728233
  5. https://clinicaltrials.gov/study/NCT01465802
  6. https://clinicaltrials.gov/study/NCT02382796
  7. https://clinicaltrials.gov/study/NCT01858389
  8. https://clinicaltrials.gov/study/NCT01571388