#1 Clinical Trials Search in Europe

Nintedanib

Nintedanib is a drug being studied in clinical trials for its potential to treat various types of cancer and lung diseases. It works by blocking enzymes involved in tumor growth and blood vessel formation. This article summarizes key information from several clinical trials investigating nintedanib’s effectiveness, safety, and optimal dosing in conditions like lung cancer, mesothelioma, and idiopathic pulmonary fibrosis.

Table of Contents

Introduction

Nintedanib is an innovative medication that has shown promise in treating various types of cancer and lung conditions. This article will provide a comprehensive overview of Nintedanib, including its uses, how it works, and what patients can expect when taking this medication.

What is Nintedanib?

Nintedanib is a type of drug known as a tyrosine kinase inhibitor. It is also referred to by its brand names Vargatef and OFEV[1][2]. This medication works by blocking specific enzymes that cancer cells need to grow and spread. By doing so, Nintedanib can help slow down or stop the progression of certain cancers and lung conditions.

Conditions Treated with Nintedanib

Nintedanib has been studied for its effectiveness in treating several conditions, including:

  • Cervical cancer: Advanced or recurrent cervical cancer[1]
  • Breast cancer: HER-negative metastatic or locally recurrent breast cancer[2]
  • Malignant pleural mesothelioma: A type of cancer that affects the lining of the lungs[4]
  • Small cell lung cancer: A fast-growing type of lung cancer[5]

These studies suggest that Nintedanib may be effective in treating various types of cancer, particularly those that have not responded well to other treatments or have recurred after initial treatment.

How Nintedanib Works

Nintedanib works by targeting multiple enzymes involved in cancer growth and progression. Specifically, it inhibits:

  • VEGFR (Vascular Endothelial Growth Factor Receptor): This helps prevent the formation of new blood vessels that feed tumors
  • FGFR (Fibroblast Growth Factor Receptor): This can help slow down cancer cell growth and division
  • PDGFR (Platelet-Derived Growth Factor Receptor): This can interfere with cancer cell survival and spread[5]

By targeting these multiple pathways, Nintedanib aims to provide a comprehensive approach to fighting cancer growth and spread.

Clinical Trials and Research

Several clinical trials have been conducted to evaluate the effectiveness and safety of Nintedanib in various cancer types:

  • A study combining Nintedanib with standard chemotherapy (carboplatin and paclitaxel) for advanced or recurrent cervical cancer[1]
  • A trial testing Nintedanib in combination with docetaxel for breast cancer treatment[2]
  • Research on Nintedanib for recurrent malignant pleural mesothelioma[4]
  • A study evaluating Nintedanib in small cell lung cancer patients who previously benefited from platinum-based chemotherapy[5]

These trials aim to determine how well Nintedanib works in different cancer types, its safety profile, and how it compares to or enhances standard treatments.

Dosage and Administration

Nintedanib is typically taken orally in the form of capsules. The dosage and administration can vary depending on the specific condition being treated and the individual patient. Some common dosing regimens observed in clinical trials include:

  • 200 mg twice daily[1][2]
  • Continuous daily dosing, with cycles typically lasting 21-28 days[4][5]

It’s important to note that dosage may be adjusted based on how well a patient tolerates the medication. Always follow your doctor’s instructions regarding dosage and administration.

Potential Side Effects

As with any medication, Nintedanib may cause side effects. Common side effects reported in clinical trials include:

  • Gastrointestinal issues (e.g., diarrhea, nausea)
  • Fatigue
  • Decreased appetite
  • Liver enzyme elevations

Your healthcare team will monitor you closely for any side effects and may adjust your dosage or provide supportive care as needed[2][4].

Frequently Asked Questions

How long do patients typically take Nintedanib?

The duration of Nintedanib treatment can vary depending on the specific condition and how well a patient responds to the medication. In some clinical trials, patients continued treatment until disease progression or unacceptable toxicity, which could be several months or even years[1].

Can Nintedanib be used alone or is it always combined with other treatments?

Nintedanib has been studied both as a standalone treatment and in combination with other therapies. For example, it has been tested in combination with chemotherapy for cervical and breast cancers[1][2], but also as a single agent in mesothelioma[4]. The best approach depends on the specific cancer type and individual patient factors.

How do I know if Nintedanib is working for me?

Your healthcare team will monitor your progress through regular check-ups and imaging tests. They will look for signs of tumor shrinkage or stabilization, as well as improvements in symptoms. The effectiveness is often measured in terms of “progression-free survival,” which is the length of time during and after treatment that the cancer does not grow or spread[4].

Summary

Aspect Details
Drug Name Nintedanib (also known as Vargatef, OFEV, BIBF 1120)
Drug Type Tyrosine kinase inhibitor
Main Uses Treatment of various cancers (cervical, breast, mesothelioma, small cell lung cancer)
How It Works Inhibits VEGFR, FGFR, and PDGFR to slow cancer growth and spread
Administration Oral capsules, typically 200 mg twice daily
Common Side Effects Gastrointestinal issues, fatigue, decreased appetite, liver enzyme elevations

Glossary

  • Tyrosine kinase inhibitor – A type of drug that blocks specific enzymes called tyrosine kinases, which are involved in many cell functions, including cell signaling, growth, and division.
  • VEGFR – Vascular Endothelial Growth Factor Receptor, a protein involved in the formation of new blood vessels.
  • FGFR – Fibroblast Growth Factor Receptor, a protein involved in cell growth and division.
  • PDGFR – Platelet-Derived Growth Factor Receptor, a protein involved in cell growth and survival.
  • Progression-free survival – The length of time during and after treatment that a patient lives with the disease but it does not get worse.

Trial sources

  • [1]: https://clinicaltrials.gov/study/NCT02009579
  • [2]: https://clinicaltrials.gov/study/NCT01658462
  • [3]: https://clinicaltrials.gov/study/NCT02572752
  • [4]: https://clinicaltrials.gov/study/NCT02568449
  • [5]: https://clinicaltrials.gov/study/NCT02152059
Aspect Details
Drug Name Nintedanib (also known as BIBF1120, Ofev, Vargatef)
Mechanism of Action Triple receptor tyrosine kinase inhibitor (targets VEGFR, FGFR, PDGFR)
Conditions Studied Non-small cell lung cancer, small cell lung cancer, mesothelioma, salivary gland cancer, endometrial cancer, idiopathic pulmonary fibrosis
Common Dosage 100-200 mg twice daily, orally
Primary Outcomes Measured Progression-free survival, overall survival, tumor response rates, safety/adverse events
Common Side Effects Diarrhea, nausea, vomiting, liver enzyme elevations
Special Populations Studied Patients with hepatic impairment, various cancer types at different stages

FAQ

  • What is nintedanib and how does it work? Nintedanib is a drug that blocks enzymes called tyrosine kinases, which are involved in tumor growth and blood vessel formation. It targets receptors like VEGFR, FGFR, and PDGFR to potentially slow or stop cancer growth and spread.
  • What types of conditions is nintedanib being studied for in clinical trials? Nintedanib is being investigated for various cancers including non-small cell lung cancer, small cell lung cancer, mesothelioma, salivary gland cancer, and endometrial cancer. It's also being studied for lung diseases like idiopathic pulmonary fibrosis.
  • How is nintedanib typically administered in clinical trials? In most trials, nintedanib is given orally as capsules, usually twice daily. The dosage often ranges from 100 mg to 200 mg twice a day, though this can vary depending on the specific trial and condition being studied.
  • What are some common side effects of nintedanib observed in trials? Common side effects can include diarrhea, nausea, vomiting, and liver enzyme elevations. The trials closely monitor patients for these and other adverse events to assess the drug's safety profile.
  • How do researchers measure if nintedanib is working in clinical trials? Researchers typically measure effectiveness through outcomes like progression-free survival, overall survival, tumor response rates, and changes in lung function tests (for lung diseases). They also assess quality of life and monitor side effects.

Ongoing Clinical Trials on Nintedanib

  • Study to evaluate the safety and effectiveness of inhaled nintedanib in patients with idiopathic pulmonary fibrosis

    Recruiting

    2 1
    Investigated drugs:
    Germany Italy Spain

  • Study on Nintedanib for Adults with Unicentric Castleman Disease

    Recruiting

    2 1 1 1
    Investigated diseases:
    Investigated drugs:
    France

  • Long-Term Study on Early Stage Breast Cancer Patients Using Capecitabine, Gemcitabine, and Paclitaxel

    Recruiting

    3 1 1 1
    Investigated drugs:
    Spain

  • Study on the Effects of Wharton’s Jelly Mesenchymal Stem Cells, Pirfenidone, and Nintedanib for Patients with Fibrotic Interstitial Lung Disease

    Recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Poland

  • Study on the Effectiveness of Nintedanib for Treating Nosebleeds in Patients with Hereditary Hemorrhagic Telangiectasia

    Not recruiting

    2 1 1
    Investigated drugs:
    France

  • Study on the Long-Term Safety of Nintedanib for Children and Adolescents with Interstitial Lung Disease

    Not recruiting

    3 1 1
    Investigated diseases:
    Investigated drugs:
    Belgium Czechia France Greece Italy Norway +2

  • Study on Idiopathic Pulmonary Fibrosis: Evaluating Pirfenidone and Nintedanib for Patients with Progressive Disease

    Not recruiting

    3 1 1 1
    Investigated diseases:
    Investigated drugs:
    France

  • Study on the Effectiveness of Nintedanib and Tocilizumab for Patients with Systemic Sclerosis and Interstitial Lung Disease

    Not recruiting

    3 1 1 1 1
    Investigated drugs:
    Poland

Glossary

  • Bioequivalence: A state where two medications with the same active ingredient have essentially the same bioavailability and produce the same effect at the site of action.
  • Progression-free survival (PFS): The length of time during and after treatment that a patient lives with the disease but it does not get worse.
  • RECIST criteria: Response Evaluation Criteria In Solid Tumors – a standard way to measure how well a cancer patient responds to treatment based on whether tumors shrink, stay the same, or get bigger.
  • Forced Vital Capacity (FVC): The total amount of air exhaled during a forced breath, used to assess lung function in conditions like idiopathic pulmonary fibrosis.
  • Child-Pugh classification: A scoring system used to assess the prognosis of chronic liver disease and cirrhosis, categorizing patients into classes A, B, and C based on severity.
  • Pharmacokinetics: The study of how a drug is absorbed, distributed, metabolized, and eliminated by the body over time.
  • Dose-limiting toxicity (DLT): Side effects of a drug that are severe enough to prevent an increase in dose or require a dose reduction in clinical trials.
  • Maximum Tolerated Dose (MTD): The highest dose of a drug that can be given without causing unacceptable side effects.