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Niraparib Tosilate Monohydrate

Niraparib Tosilate Monohydrate is an innovative drug being studied in several clinical trials for various types of cancer, including ovarian, breast, lung, and endometrial cancers. This article explores the ongoing research into this promising treatment, highlighting its potential benefits and applications across different cancer types and stages. We’ll examine how Niraparib is being tested in combination with other therapies and as a maintenance treatment to improve outcomes for cancer patients.

Table of Contents

What is Niraparib?

Niraparib tosilate monohydrate, commonly known as niraparib, is a medication used in the treatment of certain types of cancer. It belongs to a class of drugs called PARP inhibitors, which work by interfering with cancer cell growth and survival[1]. Niraparib is marketed under the brand name Zejula and is available as hard capsules or film-coated tablets[2].

How Niraparib Works

Niraparib is a highly selective poly adenosine diphosphate (ADP)-ribose polymerase (PARP) inhibitor. PARP enzymes play a crucial role in repairing damaged DNA in cells. By blocking these enzymes, niraparib makes it harder for cancer cells to repair their DNA, ultimately leading to their death[1]. This mechanism is particularly effective in cancers with defects in DNA repair pathways, such as those with BRCA mutations or homologous recombination deficiency (HRD).

Approved Uses

Niraparib is primarily approved for the treatment of advanced ovarian cancer. Specifically, it is used as a maintenance treatment for patients who have responded to platinum-based chemotherapy in the following situations:

  • Advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer
  • Recurrent ovarian cancer
  • BRCA-mutated ovarian cancer

In some cases, niraparib may also be used to treat certain types of advanced breast cancer with BRCA mutations[3].

Ongoing Research

Clinical trials are exploring the potential of niraparib in various cancer types and treatment scenarios. Some areas of ongoing research include:

  • Use in small cell lung cancer (SCLC) with high SLFN11 expression[1]
  • Combination therapy with immunotherapy drugs for ovarian cancer[2]
  • Treatment of advanced endometrial cancer[4]
  • Maintenance therapy in newly diagnosed advanced ovarian cancer[5]
  • Potential use in advanced breast and prostate cancers[6]

How Niraparib is Administered

Niraparib is taken orally, usually once daily. The typical starting dose is 200-300 mg per day, but this may vary based on individual factors such as body weight and platelet count[5]. It’s important to take niraparib exactly as prescribed by your healthcare provider.

Potential Side Effects

Like all medications, niraparib can cause side effects. Common side effects may include:

  • Fatigue
  • Nausea
  • Decreased appetite
  • Low blood cell counts (anemia, thrombocytopenia, neutropenia)
  • Headache
  • Insomnia
  • Vomiting
  • Abdominal pain

More serious side effects, though less common, can include bone marrow problems, high blood pressure, and liver problems. It’s crucial to report any side effects to your healthcare provider[6].

Important Considerations for Patients

If you’re considering or currently taking niraparib, keep these points in mind:

  • Inform your doctor about all medications, supplements, and herbal products you’re taking.
  • Regular blood tests will be necessary to monitor your blood cell counts.
  • Use effective contraception during treatment and for several months after, as niraparib can harm an unborn baby.
  • Do not breastfeed while taking niraparib and for at least 1 month after the last dose.
  • Avoid grapefruit and grapefruit juice while taking niraparib, as they may interact with the medication.

Remember, niraparib is a powerful medication that has shown significant benefits for many cancer patients. However, it’s essential to work closely with your healthcare team to monitor your progress and manage any side effects that may occur.

Aspect Details
Drug Name Niraparib Tosilate Monohydrate
Drug Class PARP (poly ADP-ribose polymerase) inhibitor
Main Cancer Types Studied Ovarian, breast, lung, endometrial, prostate
Key Trial Phases Phase 1b, 2, and 3
Common Trial Designs Randomized, double-blind, placebo-controlled
Primary Endpoints Progression-free survival (PFS), Overall survival (OS)
Secondary Endpoints Objective response rate, Duration of response, Quality of life measures
Dosage Forms Oral capsules or tablets
Typical Dosing 200-300 mg daily, adjusted based on weight and platelet count
Treatment Duration Varies by trial, often until disease progression or unacceptable toxicity

FAQ

  • What is Niraparib Tosilate Monohydrate? Niraparib Tosilate Monohydrate is a type of drug called a PARP inhibitor. It works by blocking an enzyme that cancer cells use to repair their DNA, which can help stop cancer growth and potentially kill cancer cells.
  • What types of cancer is Niraparib being studied for? Niraparib is being investigated for several types of cancer, including advanced ovarian cancer, breast cancer, small cell lung cancer, endometrial cancer, and prostate cancer.
  • How is Niraparib given to patients in clinical trials? In most trials, Niraparib is given as an oral medication, usually in the form of capsules or tablets. The dosage and frequency may vary depending on the specific trial and the patient's condition.
  • What are some potential side effects of Niraparib? Common side effects may include fatigue, nausea, low blood cell counts, and changes in blood pressure. However, the full range of side effects is still being studied in clinical trials.
  • How long do patients typically take Niraparib in clinical trials? The duration of treatment varies depending on the trial design and the patient's response. Some trials investigate Niraparib as a maintenance therapy, which means patients may take it for extended periods, sometimes up to 3 years or more, as long as they continue to benefit from the treatment.

Ongoing Clinical Trials on Niraparib Tosilate Monohydrate

  • Comparison of Niraparib alone versus Niraparib with Bevacizumab in patients with newly diagnosed advanced ovarian cancer after chemotherapy with carboplatin and paclitaxel

    Recruiting

    3 1 1 1
    Investigated drugs:
    Belgium Czechia Germany Italy

  • Study on Niraparib with Immunotherapy for Patients with SLFN11-Positive Extensive-Stage Small Cell Lung Cancer

    Recruiting

    2 1 1 1
    Investigated diseases:
    Investigated drugs:
    France Germany Italy Romania Spain

  • Study on Niraparib, Carboplatin, and Paclitaxel for Advanced Ovarian Cancer Patients After Tumor Removal

    Recruiting

    2 1 1 1
    Investigated diseases:
    Investigated drugs:
    Austria Belgium Czechia Germany Italy Spain

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

    Recruiting

    2 1 1 1
    Investigated diseases:
    Investigated drugs:
    The Netherlands

  • Study of drug combination in patients with advanced cancer based on genomic profiling – ProTarget Danish nationwide trial

    Recruiting

    2 1 1 1
    Investigated drugs:
    Denmark

  • Study on the Effectiveness of Niraparib Rechallenge After Surgery in Ovarian Cancer Patients with Limited Metastasis

    Recruiting

    2 1 1
    Investigated diseases:
    Investigated drugs:
    Spain

  • Study of Paclitaxel, Carboplatin, and Bevacizumab with Niraparib for Patients with Advanced Ovarian, Tubal, or Peritoneal Cancer After Surgery

    Recruiting

    2 1 1 1
    Investigated diseases:
    Investigated drugs:
    Belgium France Italy Spain

  • Long-term Safety Study of Niraparib for Patients with Advanced Ovarian, Breast, or Prostate Cancer Who Completed a Previous Niraparib Study

    Recruiting

    2 1 1 1
    Investigated diseases:
    Investigated drugs:
    Austria France Germany Italy Romania Spain

  • Study on Dostarlimab and Niraparib for Patients with Metastatic or Recurrent Endometrial or Ovarian Carcinosarcoma

    Recruiting

    2 1 1 1
    Investigated diseases:
    Investigated drugs:
    France Italy Spain

  • Phase 3 Randomized Study of Niraparib Tosilate Monohydrate vs. Temozolomide in Newly Diagnosed MGMT Unmethylated Glioblastoma

    Not yet recruiting

    3 1 1 1
    Investigated diseases:
    Investigated drugs:
    Denmark France Germany Ireland Italy The Netherlands +2

Glossary

  • PARP inhibitor: A type of drug that blocks an enzyme called poly (ADP-ribose) polymerase, which helps repair DNA damage in cells. By blocking this enzyme, PARP inhibitors may prevent cancer cells from repairing their damaged DNA, leading to cell death.
  • Homologous Recombination Deficiency (HRD): A condition in which cells have trouble repairing certain types of DNA damage. Some cancers with HRD may be more sensitive to treatments like PARP inhibitors.
  • Maintenance therapy: Treatment given to help keep cancer from coming back after it has responded to initial treatment. It may include chemotherapy, hormone therapy, or other treatments.
  • Progression-free survival (PFS): The length of time during and after treatment that a patient lives with cancer without it getting worse. This is often used to measure how well a cancer treatment works.
  • Overall survival (OS): The length of time from the start of treatment or diagnosis that patients are still alive. This is an important measure of how effective a cancer treatment is.
  • 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.
  • Biomarker: A biological molecule found in blood, other body fluids, or tissues that is a sign of a normal or abnormal process, or of a condition or disease. Biomarkers may be used to see how well the body responds to a treatment for a disease or condition.
  • Neoadjuvant therapy: Treatment given before the main treatment, usually to shrink a tumor before surgery.
  • Adjuvant therapy: Additional cancer treatment given after the primary treatment to lower the risk that the cancer will come back.
  • Cytotoxic therapy: Treatment that kills cells, including cancer cells. Traditional chemotherapy drugs are cytotoxic agents.

References

  1. http://clinicaltrials.eu/trial/study-on-niraparib-with-immunotherapy-for-patients-with-slfn11-positive-extensive-stage-small-cell-lung-cancer/
  2. http://clinicaltrials.eu/trial/study-on-niraparib-carboplatin-and-paclitaxel-for-advanced-ovarian-cancer-patients-after-tumor-removal/
  3. http://clinicaltrials.eu/trial/study-on-niraparib-for-patients-with-her2-negative-brca-mutated-or-triple-negative-breast-cancer-with-molecular-disease-detected-by-ctdna/
  4. http://clinicaltrials.eu/trial/study-on-dostarlimab-carboplatin-and-paclitaxel-for-patients-with-recurrent-or-advanced-endometrial-cancer/
  5. http://clinicaltrials.eu/trial/study-on-niraparib-for-maintenance-treatment-in-patients-with-advanced-ovarian-cancer-after-initial-chemotherapy-response/
  6. http://clinicaltrials.eu/trial/long-term-safety-study-of-niraparib-for-patients-with-advanced-ovarian-breast-or-prostate-cancer-who-completed-a-previous-niraparib-study/