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Pancreatic CancerPhase 2NIRA-PANCNCT03553004

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

A Phase 2 study testing Niraparib Treatment in people with Pancreatic Cancer, run by University of Kansas Medical Center at 6 sites in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Pancreatic Cancer
What is being tested?
Niraparib Treatment
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
18 participants
Where
6 sitesUnited States
Study dates
22 Jan 2019to 1 Feb 2025
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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.
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  • 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)

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

United States6 sites

  • University of Kansas Cancer Center - Clinical Research Center

    Fairway, Kansas, 66208

  • University of Kansas Cancer Center - West

    Kansas City, Kansas, 66112

  • University of Kansas Cancer Center - North

    Kansas City, Missouri, 64154

  • University of Kansas Cancer Center - Lee's Summit

    Lee's Summit, Missouri, 64064

  • University of Kansas Cancer Center - Overland Park

    Overland Park, Kansas, 66210

  • The University of Kansas Cancer Center

    Westwood, Kansas, 66205

Other trials in United States

About this study

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.

Being tested
Niraparib Treatment
Keywords
Metastatic pancreatic cancer, germline mutation, somatic mutation, Niraparib, pancreas
Medical subject headings
Pancreatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Niraparib TreatmentDrug

    Niraparib treatment by mouth (oral)

Study groups in NCT03553004
Study groupRoleWhat they receive
Niraparib TreatmentExperimental* 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)).
Receives: Drug: Niraparib Treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

    Measured: 8 weeks

Secondary outcomes (5)

  1. Progression Free Survival (PFS)

    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).

    Measured: Up to 5 years

  2. Overall Survival (OS)

    Calculated as the average length of time of survival from the time of initial study treatment until the time of death from any cause.

    Measured: Up to 5 years

  3. Disease Control

    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

    Measured: 8 weeks

  4. Duration of Response

    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).

    Measured: Up to 5 years

  5. Proportion of participants with adverse events (AEs)

    Defined per Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.

    Measured: Up to 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Jun 2018
  2. Study start22 Jan 2019
  3. Primary completion25 Apr 2023
  4. Study completion1 Feb 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
18 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03553004
Sponsor's protocol ID
IIT-2017-NIRA-PANC
Acronym
NIRA-PANC
Status last verified
May 2023
First submitted
30 May 2018
Last updated
19 May 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Kasi A, Al-Rajabi RMT, Baranda JC, Saeed A, Dai J, Chalise P, Weir S, Sear B, Carroll E, Bradbury S, Tripathi A, Hyter S, Beeki V, McKittrick RJ, Kumer S, Schmitt T, Soper S, Godwin AK, Sun W. Niraparib in pancreatic cancer with germline or somatic DNA damage repair (DDR) gene alterations (BRCA and beyond): a phase II study (NIRA-PANC). Oncologist. 2026 Jul 8;31(8):oyag225. doi: 10.1093/oncolo/oyag225.

    PubMed 42249558

  • 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.

    PubMed 37759489

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Niraparib Treatment in people with Pancreatic Cancer, run by University of Kansas Medical Center at 6 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 19 May 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Response Rate (ORR) (time frame: 8 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03553004, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2023.

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