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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03553004
Recruitment Status : Recruiting
First Posted : June 12, 2018
Last Update Posted : May 3, 2021
Sponsor:
Collaborator:
Tesaro, Inc.
Information provided by (Responsible Party):
University of Kansas Medical Center

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Pancreatic Cancer Drug: Niraparib Treatment Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 18 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Niraparib in Metastatic Pancreatic Cancer After Previous Chemotherapy (NIRA-PANC): a Phase 2 Trial
Actual Study Start Date : January 22, 2019
Estimated Primary Completion Date : June 28, 2023
Estimated Study Completion Date : February 1, 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Niraparib Treatment
  • Niraparib 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)).
 Drug: Niraparib Treatment
Niraparib treatment by mouth (oral)


Outcome Measures
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Primary Outcome Measures :
  1. Objective Response Rate (ORR) [ Time Frame: 8 weeks ]
    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 :
  1. Progression Free Survival (PFS) [ Time Frame: Up to 5 years ]
    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).

  2. Overall Survival (OS) [ Time Frame: Up to 5 years ]
    Calculated as the average length of time of survival from the time of initial study treatment until the time of death from any cause.

  3. Disease Control [ Time Frame: 8 weeks ]
    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

  4. Duration of Response [ Time Frame: Up to 5 years ]
    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).

  5. Proportion of participants with adverse events (AEs) [ Time Frame: Up to 5 years ]
    Defined per Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03553004


Contacts
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Contact: Clinical Trials Nurse Navigator 913-588-3671 navigation@kumc.edu

Locations
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United States, Kansas
University of Kansas Cancer Center - Clinical Research Center Recruiting
Fairway, Kansas, United States, 66208
Contact: kerry hepler    913-945-7552    ctnursenav@kumc.edu   
University of Kansas Cancer Center - West Recruiting
Kansas City, Kansas, United States, 66112
Contact: Kerry Hepler    913-945-7552    ctnursenav@kumc.edu   
University of Kansas Cancer Center - Overland Park Recruiting
Overland Park, Kansas, United States, 66210
Contact: kerry hepler    913-945-7552    ctnursenav@kumc.edu   
The University of Kansas Cancer Center Recruiting
Westwood, Kansas, United States, 66205
Contact: Kerry Hepler, RN    913-945-7552    ctnursenav@kumc.edu   
Principal Investigator: Anup Kasi, MD         
United States, Missouri
University of Kansas Cancer Center - North Recruiting
Kansas City, Missouri, United States, 64154
Contact: kerr hepler    913-945-7552    ctnursenav@kumc.edu   
Principal Investigator: Anup Kasi, MD         
University of Kansas Cancer Center - Lee's Summit Recruiting
Lee's Summit, Missouri, United States, 64064
Contact: Kerry Hepler    913-945-7552    ctnursenav@kumc.edu   
Sponsors and Collaborators
University of Kansas Medical Center
Tesaro, Inc.
Investigators
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Principal Investigator: Anup Kasi, MD The University of Kansas Cancer Center
More Information
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Responsible Party: University of Kansas Medical Center
ClinicalTrials.gov Identifier: NCT03553004    
Other Study ID Numbers: IIT-2017-NIRA-PANC
First Posted: June 12, 2018    Key Record Dates
Last Update Posted: May 3, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Kansas Medical Center:
Metastatic pancreatic cancer
germline mutation
somatic mutation
Niraparib
pancreas
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
 Endocrine System Diseases
Niraparib
Poly(ADP-ribose) Polymerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents