Clinical Trials /

Niraparib in Metastatic Pancreatic Cancer After Previous Chemotherapy (NIRA-PANC): a Phase 2 Trial

NCT03553004

Description:

The goal of this clinical research study is to learn if Niraparib can help to control metastatic pancreatic cancer. The safety of this drug will also be studied. Niraparib is FDA approved and commercially available for the treatment of ovarian cancer. Its use in this study is investigational.

Related Conditions:
  • Pancreatic Adenocarcinoma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Niraparib in Metastatic Pancreatic Cancer After Previous Chemotherapy (NIRA-PANC): a Phase 2 Trial
  • Official Title: Niraparib in Metastatic Pancreatic Cancer After Previous Chemotherapy (NIRA-PANC): a Phase 2 Trial

Clinical Trial IDs

  • ORG STUDY ID: IIT-2017-NIRA-PANC
  • NCT ID: NCT03553004

Conditions

  • Pancreatic Cancer

Interventions

DrugSynonymsArms
Niraparib TreatmentNiraparib Treatment

Purpose

The goal of this clinical research study is to learn if Niraparib can help to control metastatic pancreatic cancer. The safety of this drug will also be studied. Niraparib is FDA approved and commercially available for the treatment of ovarian cancer. Its use in this study is investigational.

Trial Arms

NameTypeDescriptionInterventions
Niraparib TreatmentExperimentalNiraparib 300 milligrams (mg) by mouth daily for 28 days (1 cycle = 28 days) (Dose reduced to 200mg dose for participants whose baseline weight is less than 77 kilograms (kg) [169.756 pounds (lbs)] or baseline platelet count is less than 150,000 microliters (µL)).
  • Niraparib Treatment

Eligibility Criteria

        Key Inclusion Criteria:

          -  Screening tumor tissue analysis positive with germline or somatic mutation in genes
             involved in DNA repair.

          -  Ability of participant or Legally Authorized Representative (LAR) to understand this
             study, and participant or LAR willingness to sign a written informed consent.

          -  Able to swallow oral study drug

          -  Histologically or cytologically confirmed adenocarcinoma of the exocrine pancreas

          -  Measurable disease

          -  Patients with history of other, non-pancreatic cancers with no evidence of active
             disease are eligible.

          -  Participants who have had any prior chemotherapy as first line and/or second line
             therapy for metastatic disease are eligible to seek enrollment. Patients who refuse
             chemotherapy or do not tolerate chemotherapy are eligible.

          -  Patients must have adequate organ function

          -  Women must have a negative serum pregnancy test within 72 hours to taking study
             treatment.

          -  Women of child-bearing potential and men with partners of child-bearing potential must
             agree to practice sexual abstinence, or to use approved forms of contraception prior
             to study entry, for the duration of study participation, and for 180 days following
             completion of therapy.

        Key Exclusion Criteria:

          -  Patients simultaneously enrolled in any therapeutic clinical trial

          -  Patients have had investigational therapy administered within the past 4 weeks

          -  Current or anticipated use of other investigational agents while participating in this
             study.

          -  Patient has had prior treatment with a known poly polymerase inhibitor

          -  Psychiatric illness/social situations that would limit compliance with study
             requirements.

          -  Pregnant, breast feeding or expecting to conceive children while receiving study
             treatment and for 180 days after the last dose of study treatment. There is a
             potential for congenital abnormalities and for this regimen to harm breast feeding
             infants.

          -  Patients must not have a known hypersensitivity to the components of niraparib or the
             excipients

          -  Patients must not have had major surgery within the last 3 weeks of starting the study
             and patient must have recovered from any effects of any major surgery

          -  Patients must not have had radiotherapy encompassing more than 20% of the bone marrow
             within 2 weeks or any radiation therapy within 1 week prior to Day 1 of protocol
             therapy

          -  Patients must not be immuno-compromised. Patients with splenectomy are allowed.

          -  Patients must not have received a transfusion (platelets or red blood cells) within 4
             weeks of the first dose of study treatment

          -  Patients must not have current evidence of any condition, therapy, or laboratory
             abnormality that might confound the results of the study or interfere with the
             patient's participation for the full duration of the study treatment or that makes it
             not in the best interest of the patient to participate

          -  Patients must not have known, symptomatic brain or leptomeningeal metastases

          -  Patient must not have any known history of myelodysplastic syndrome (MDS) or acute
             myeloid leukemia (AML)
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Objective Response Rate (ORR)
Time Frame:8 weeks
Safety Issue:
Description:Defined as the percentage of participants with overall response to therapy at 8 weeks, defined as Partial Response or Complete Response (PR + CR) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1)

Secondary Outcome Measures

Measure:Progression Free Survival (PFS)
Time Frame:Up to 5 years
Safety Issue:
Description:Calculated as the percentage of participants with PFS from the time of initial study treatment until the time of progression, defined per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1).
Measure:Overall Survival (OS)
Time Frame:Up to 5 years
Safety Issue:
Description:Calculated as the average length of time of survival from the time of initial study treatment until the time of death from any cause.
Measure:Disease Control
Time Frame:8 weeks
Safety Issue:
Description:Calculated as the percentage of participants that achieve any of the following at 8 weeks: complete response, partial response, or stable disease, as defined by RECIST v1.1
Measure:Duration of Response
Time Frame:Up to 5 years
Safety Issue:
Description:Calculated as the average length of time between response to treatment and disease progression, defined per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1).
Measure:Proportion of participants with adverse events (AEs)
Time Frame:Up to 5 years
Safety Issue:
Description:Defined per Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:University of Kansas Medical Center

Trial Keywords

  • Metastatic pancreatic cancer
  • germline mutation
  • somatic mutation
  • Niraparib
  • pancreas

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