Study on Niraparib for Treating Pancreatic Cancer

Sponsor: Dana-Farber Cancer Institute

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT03601923

Provider View

This clinical trial is exploring the use of niraparib, a drug not yet approved for pancreatic cancer, to see if it can help treat this disease. Niraparib is already used for other conditions and works by blocking a protein that helps repair DNA in cancer cells, potentially causing them to die.

Patient Parameters

Program Overview

This study is a Phase II clinical trial, which means it is testing the safety and effectiveness of niraparib in treating pancreatic cancer. Niraparib is a type of drug known as a PARP inhibitor, which blocks a protein that repairs DNA in cells. By blocking this protein, niraparib may help kill cancer cells that grow quickly. The study focuses on patients with pancreatic cancer who have a specific genetic marker that suggests their cancer might respond well to niraparib.

Description

This Phase II clinical trial is investigating the use of niraparib, a drug that has not been approved for pancreatic cancer but is used for other conditions. Niraparib is a PARP inhibitor, which means it blocks a protein that helps repair DNA in cells. This can be beneficial in cancer treatment because it may cause cancer cells to die. The trial aims to test the effectiveness of niraparib in patients with pancreatic cancer who have a specific mutation in a DNA repair gene, indicating that their cancer might be susceptible to this treatment. Participants will receive niraparib and be monitored for safety and effectiveness.

Eligibility Criteria

Inclusion Criteria

  • Must have advanced pancreatic cancer that cannot be cured with standard treatments.
  • Must have specific genetic mutations in DNA repair genes like BRCA1, BRCA2, PALB2, CHEK2, or ATM.
  • Must have received at least one previous treatment for pancreatic cancer.
  • Must not have progressed on treatments containing oxaliplatin.
  • Must have measurable disease that can be tracked with scans.
  • Must be 18 years or older.
  • Must have good overall health with an ECOG performance status of 0 or 1.
  • Must have adequate organ and bone marrow function based on specific blood test results.
  • Women must not be pregnant and must agree to use effective birth control during and after the study.
  • Men must agree to use effective birth control during and after the study.
  • Must agree not to donate blood during and after the study.
  • Must be able to swallow pills and understand the study requirements.
  • Must be willing to undergo a tumor biopsy before starting treatment.

Exclusion Criteria

  • Must not have had recent chemotherapy, radiation, or other cancer treatments within the last 2 weeks.
  • Must not have received investigational therapy within the last 4 weeks.
  • Must not have been treated with a PARP inhibitor before.
  • Must not have untreated brain metastases.
  • Must not have a history of severe allergic reactions to niraparib.
  • Must not be immunocompromised.
  • Must not have received a blood transfusion within the last 4 weeks.
  • Must not have a history of certain blood disorders like myelodysplastic syndrome or acute myeloid leukemia.
  • Must not have uncontrolled illnesses or infections.
  • Must not be HIV-positive.
  • Must not have gastrointestinal disorders that affect drug absorption.
  • Must not have had another significant cancer within the last 2 years, except for certain skin cancers or carcinoma in situ.
  • Must not be on anticoagulant therapy unless deemed safe by the investigator.
  • Must not have received colony stimulating factors within the last 4 weeks.
  • Must not have had severe blood cell count issues from previous chemotherapy.

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