Study on Niraparib for Cancer Spread to the Central Nervous System (CNS)

Sponsor: Massachusetts General Hospital

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04992013

Provider View

This clinical trial is testing the effectiveness of the drug niraparib in treating cancer that has spread to the brain and spinal cord. The study aims to see if niraparib can help control these types of cancer.

Patient Parameters

Program Overview

This study is exploring the use of niraparib, a drug not yet approved for cancer that has spread to the central nervous system (CNS), to see if it can help treat these cancers. Niraparib is a PARP inhibitor, which means it works by preventing cancer cells from repairing their DNA, potentially leading to their death. Participants will receive the drug for up to two years, or until their cancer worsens or they experience unacceptable side effects. The study will involve about 20 participants, who will be monitored regularly to assess the drug's effectiveness and safety. GlaxoSmithKline is funding this research.

Description

This clinical trial is designed to test the safety and effectiveness of niraparib in treating cancers that have spread to the central nervous system (CNS), such as the brain and spinal cord. Niraparib is a type of medication known as a PARP inhibitor, which can help kill cancer cells by preventing them from repairing their DNA. Although niraparib is approved for other uses, it is not yet approved for treating CNS metastases.

Participants in this study will receive niraparib for up to two years, unless their cancer progresses, they experience severe side effects, or they meet other criteria for stopping the treatment. The study includes regular check-ups and follow-up visits every four months for up to two years after treatment ends.

Approximately 20 people will participate in this study, which is supported by GlaxoSmithKline, a pharmaceutical company providing the study drug and funding.

Eligibility Criteria

Inclusion Criteria

  • Must have a confirmed diagnosis of cancer from any solid tumor.
  • Must have cancer that has spread to the CNS and is either not causing symptoms or causing minimal symptoms for at least 7 days before starting the study.
  • Must have at least one measurable tumor in the CNS that is 10 mm or larger.
  • Must have progressive CNS tumors, with specific conditions for eligibility.
  • Must have certain types of cancer, such as triple-negative breast cancer or ovarian cancer, or specific genetic changes related to DNA repair.
  • Must be over 18 years old.
  • Must have a performance status score of 2 or lower, indicating the ability to carry out daily activities.
  • Must have normal organ and bone marrow function based on specific blood test results.
  • Female participants must have a negative pregnancy test and agree to use effective birth control during the study and for 180 days after the last dose.
  • Must agree not to breastfeed during the study and for 30 days after the last dose.
  • Must be able to understand and sign a consent form.
  • Must provide tissue samples for genetic testing if available.
  • Must agree not to donate blood during the study and for 90 days after the last dose.
  • Must be on a stable dose of corticosteroids for at least 7 days.
  • Must be able to swallow capsules.

Exclusion Criteria

  • Cannot have been treated with a PARP inhibitor before.
  • Cannot have had chemotherapy, immunotherapy, or radiotherapy within 2 weeks before starting the study, unless on specific medications.
  • Cannot have had major surgery within 3 weeks before starting the study.
  • Cannot have received investigational therapy within 4 weeks before starting the study.
  • Cannot have had radiation therapy affecting more than 20% of the bone marrow within 2 weeks before starting the study.
  • Cannot have a known allergy to niraparib or its components.
  • Cannot have received a blood transfusion within 4 weeks before starting the study.
  • Cannot have received certain growth factors within 4 weeks before starting the study.
  • Cannot have had severe blood disorders related to previous chemotherapy.
  • Cannot have a history of myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML).
  • Cannot have serious, uncontrolled medical conditions or infections.
  • Cannot have been diagnosed with another type of cancer within 2 years before starting the study, except for certain skin or cervical cancers.
  • Cannot undergo MRI scans.

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