NCT03553004

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
18

participants targeted

Target at below P25 for phase_2 pancreatic-cancer

Timeline
Completed

Started Jan 2019

Longer than P75 for phase_2 pancreatic-cancer

Geographic Reach
1 country

6 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 30, 2018

Completed
13 days until next milestone

First Posted

Study publicly available on registry

June 12, 2018

Completed
7 months until next milestone

Study Start

First participant enrolled

January 22, 2019

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 25, 2023

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2025

Completed
Last Updated

May 19, 2023

Status Verified

May 1, 2023

Enrollment Period

4.3 years

First QC Date

May 30, 2018

Last Update Submit

May 18, 2023

Conditions

Pancreatic Cancer

Keywords

Metastatic pancreatic cancergermline mutationsomatic mutationNiraparibpancreas

Outcome Measures

Primary Outcomes (1)

  • Objective Response Rate (ORR)

    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)

    8 weeks

Secondary Outcomes (5)

  • Progression Free Survival (PFS)

    Up to 5 years

  • Overall Survival (OS)

    Up to 5 years

  • Disease Control

    8 weeks

  • Duration of Response

    Up to 5 years

  • Proportion of participants with adverse events (AEs)

    Up to 5 years

Study Arms (1)

Niraparib Treatment

EXPERIMENTAL

* 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

Interventions

Niraparib TreatmentDRUG

Niraparib treatment by mouth (oral)

Niraparib Treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

University of Kansas Cancer Center - Clinical Research Center

Fairway, Kansas, 66208, United States

Location

University of Kansas Cancer Center - West

Kansas City, Kansas, 66112, United States

Location

University of Kansas Cancer Center - Overland Park

Overland Park, Kansas, 66210, United States

Location

The University of Kansas Cancer Center

Westwood, Kansas, 66205, United States

Location

University of Kansas Cancer Center - North

Kansas City, Missouri, 64154, United States

Location

University of Kansas Cancer Center - Lee's Summit

Lee's Summit, Missouri, 64064, United States

Location

Related Publications (1)

  • Freed IM, Kasi A, Fateru O, Hu M, Gonzalez P, Weatherington N, Pathak H, Hyter S, Sun W, Al-Rajabi R, Baranda J, Hupert ML, Chalise P, Godwin AK, A Witek M, Soper SA. Circulating Tumor Cell Subpopulations Predict Treatment Outcome in Pancreatic Ductal Adenocarcinoma (PDAC) Patients. Cells. 2023 Sep 13;12(18):2266. doi: 10.3390/cells12182266.

    PMID: 37759489DERIVED

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System Diseases

Study Officials

  • Anup Kasi, MD

    The University of Kansas Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 30, 2018

First Posted

June 12, 2018

Study Start

January 22, 2019

Primary Completion

April 25, 2023

Study Completion

February 1, 2025

Last Updated

May 19, 2023

Record last verified: 2023-05

Locations

US(6)