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Niraparib

Niraparib, a promising drug in cancer treatment, is being extensively studied in various clinical trials. These trials aim to evaluate its effectiveness, safety, and potential applications across different types of cancers. The research focuses on using Niraparib as a maintenance therapy, in combination with other drugs, and for specific genetic mutations in cancer patients.

Table of Contents

What is Niraparib?

Niraparib, also known by its brand name Zejula, is a medication that belongs to a class of drugs called PARP inhibitors. PARP stands for poly(ADP-ribose) polymerase, which is a protein in our body that helps repair damaged DNA. Niraparib works by blocking this protein, which can be beneficial in treating certain types of cancers[1][2].

How Niraparib Works

Niraparib targets cancer cells by interfering with their ability to repair DNA damage. In normal cells, PARP proteins help fix minor damage to DNA. However, in cancer cells, especially those with certain genetic mutations, blocking PARP can lead to the accumulation of DNA damage, eventually causing the cancer cells to die. This approach is particularly effective in cancers with mutations in genes involved in DNA repair, such as BRCA1, BRCA2, or PALB2[3][4].

Conditions Treated with Niraparib

Niraparib is primarily used to treat several types of cancers, including:

  • Ovarian Cancer: Niraparib is approved for maintenance treatment in women with advanced ovarian cancer who have responded to platinum-based chemotherapy[5].
  • Breast Cancer: Clinical trials are exploring its use in certain types of breast cancer, especially those with BRCA mutations[6].
  • Pancreatic Cancer: Research is ongoing to evaluate niraparib’s effectiveness in pancreatic cancer patients with specific genetic mutations[2].
  • Colorectal Cancer: Studies are investigating niraparib as a maintenance treatment for metastatic colorectal cancer[7].
  • Other Solid Tumors: Clinical trials are exploring niraparib’s potential in treating various advanced solid tumors with specific genetic mutations, including lung, urologic, esophageal, endometrial, and head and neck cancers[4].

How Niraparib is Administered

Niraparib is typically taken orally as a capsule or tablet, once daily. The dosage may vary depending on factors such as body weight, platelet count, and individual patient characteristics. Some key points about niraparib administration include:

  • The usual starting dose ranges from 200 mg to 300 mg per day, but this can be adjusted based on how well a patient tolerates the medication[1].
  • It’s often used as a maintenance therapy, which means it’s given after initial treatment (such as chemotherapy) to help keep cancer from coming back[5].
  • In some cases, doctors may use a dose escalation approach, starting with a lower dose and gradually increasing it to find the best balance between effectiveness and side effects[8].

Current Clinical Trials

Niraparib is the subject of numerous ongoing clinical trials aimed at expanding its use and understanding its effects in various cancer types. Some notable areas of research include:

  • Combination Therapies: Studies are exploring the use of niraparib in combination with other cancer treatments, such as immunotherapy drugs[3].
  • Expanded Cancer Types: Researchers are investigating niraparib’s potential in treating a wider range of cancers, especially those with specific genetic mutations[4].
  • Optimizing Dosage: Trials are looking at different dosing strategies to maximize effectiveness while minimizing side effects[8].
  • Long-term Effects: Studies are assessing the long-term benefits and safety of niraparib maintenance therapy[5].

Potential Side Effects

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

  • Fatigue: Feeling unusually tired or weak is a common side effect[5].
  • Nausea and Vomiting: These symptoms can often be managed with additional medications[1].
  • Blood Count Changes: Niraparib can affect blood cell counts, potentially leading to anemia (low red blood cells) or thrombocytopenia (low platelets)[8].
  • Headache: Some patients may experience headaches while taking niraparib[1].

It’s important to discuss any side effects with your healthcare provider, as they can often be managed through dose adjustments or supportive care measures[1].

Aspect Details
Drug Name Niraparib (also known as Zejula)
Drug Class PARP (poly ADP ribose polymerase) inhibitor
Primary Cancers Studied Ovarian, breast, pancreatic, colorectal, and other solid tumors
Key Study Objectives Efficacy, safety, tolerability, pharmacokinetics, biomarker analysis
Common Outcome Measures Progression-free survival, overall survival, objective response rate, duration of response
Administration Oral, typically once daily
Notable Trial Designs Maintenance therapy, combination with other drugs, focus on specific genetic mutations (e.g., BRCA, PALB2)
Safety Monitoring Adverse events, with special attention to hematologic toxicities

FAQ

  • What is Niraparib? Niraparib is a type of drug called a PARP inhibitor. It works by blocking a protein in the body that helps repair damaged DNA in cancer cells, potentially causing those cells to die.
  • What types of cancer is Niraparib being tested for? Niraparib is being tested for various cancers including ovarian cancer, breast cancer, pancreatic cancer, colorectal cancer, and other solid tumors. Some trials are specifically looking at its effectiveness in cancers with certain genetic mutations.
  • How is Niraparib administered in these trials? In most trials, Niraparib is given as an oral medication, usually taken once daily. The dosage may vary depending on the specific trial and the patient's characteristics.
  • What are some of the potential side effects of Niraparib? Common side effects being monitored in these trials include changes in blood cell counts (like thrombocytopenia), fatigue, and nausea. The trials are carefully assessing the safety and tolerability of Niraparib.
  • How long do patients typically take Niraparib in these trials? The duration varies by trial. Some studies use Niraparib as a maintenance therapy for extended periods, while others may have shorter treatment periods. Many trials continue treatment until disease progression or unacceptable toxicity occurs.

Ongoing Clinical Trials on Niraparib

  • 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 the Effectiveness of Tepotinib and Drug Combination for Patients with Advanced Cancer

    Recruiting

    2 1 1 1
    Investigated drugs:
    Norway

  • Study on Niraparib and Dostarlimab for Patients with HPV-Negative Head and Neck Squamous Cell Carcinoma

    Recruiting

    2 1 1 1
    Investigated diseases:
    Investigated drugs:
    Italy

  • Study on Niraparib and Dostarlimab for Patients with Recurrent Ovarian, Fallopian Tube, or Primary Peritoneal Cancer Not Suitable for Platinum Treatment

    Recruiting

    3 1 1 1
    Investigated diseases:
    Investigated drugs:
    Czechia France Germany Italy

  • 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

  • Study on the Effectiveness of Abiraterone, Capivasertib, and Enzalutamide in Patients with Metastatic Prostate Cancer

    Recruiting

    3 1 1 1
    Investigated diseases:
    Investigated drugs:
    Belgium Norway Sweden

  • Study on Maintenance Therapy with Cisplatin, Durvalumab, and Trastuzumab for Patients with Advanced Biliary Cancer

    Recruiting

    3 1 1 1
    Investigated drugs:
    Belgium France

  • Study on the Effect of Metastasis-Directed Therapy with Lutetium (177Lu) Zadavotide Guraxetan in Patients with Advanced Prostate Cancer and Up to 5 Progressive Lesions

    Recruiting

    3 1 1 1
    Investigated diseases:
    Investigated drugs:
    Belgium

  • Study of Niraparib and Dostarlimab for Patients with Advanced Non-Small Cell Lung Cancer or Malignant Pleural Mesothelioma with Specific Genetic Mutations

    Not yet recruiting

    2 1 1 1
    Investigated diseases:
    Investigated drugs:
    Italy

  • Study on Niraparib and Dostarlimab for Patients with DNA Repair-Deficient or Platinum-Sensitive Solid Tumors

    Not recruiting

    2 1 1 1
    Investigated drugs:
    France

Glossary

  • PARP inhibitor: A type of drug that blocks the activity of poly (ADP-ribose) polymerase (PARP) enzymes, which help repair DNA damage in cells. By inhibiting PARP, these drugs can prevent cancer cells from repairing their DNA, leading to cell death.
  • Maintenance therapy: Treatment given to help keep cancer from coming back after it has disappeared following the initial therapy. It may include treatment with drugs, vaccines, or antibodies that kill cancer cells, and it may be given for a long time.
  • Progression-free survival (PFS): The length of time during and after treatment that a patient lives with cancer without it worsening. This is an important measure of how well a cancer treatment works.
  • Overall survival (OS): The length of time from either the date of diagnosis or the start of treatment for a disease that patients are still alive.
  • 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. In cancer, a biomarker may be used to see how well the body responds to a treatment for a disease or condition.
  • Homologous recombination deficiency (HRD): A defect in a type of DNA repair mechanism called homologous recombination. Tumors with HRD may be more sensitive to certain treatments, including PARP inhibitors.
  • RECIST criteria: Response Evaluation Criteria in Solid Tumors, a standard way to measure how well a cancer patient responds to treatment. It is based on whether tumors shrink, stay the same, or get bigger.
  • Dose-limiting toxicity (DLT): Side effects of a drug or other treatment that are serious enough to prevent an increase in dose or level of that treatment.
  • Pharmacokinetics (PK): The study of how a drug is absorbed, distributed, metabolized, and eliminated by the body.
  • Objective response rate (ORR): The proportion of patients whose cancer shrinks or disappears after treatment.

References

  1. https://clinicaltrials.gov/study/NCT03329001
  2. https://clinicaltrials.gov/study/NCT03601923
  3. https://clinicaltrials.gov/study/NCT04655183
  4. https://clinicaltrials.gov/study/NCT05169437
  5. https://clinicaltrials.gov/study/NCT03752216
  6. https://clinicaltrials.gov/study/NCT04544995
  7. https://clinicaltrials.gov/study/NCT05412706
  8. https://clinicaltrials.gov/study/NCT05961124