← Back to Search

PARP Inhibitor

Niraparib for Pancreatic Cancer

Phase 2
Waitlist Available
Led By James Cleary, MD, PhD
Research Sponsored by Dana-Farber Cancer Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients must have molecular characteristics that fulfill specific requirements related to germline and somatic mutations in BRCA1, BRCA2, PALB2, CHEK2, or ATM, with testing performed in CLIA approved laboratories.
Age ≥ 18 years.
Must not have
Participants with a history of a clinically relevant second primary malignancy within the past 2 years.
Participant must not have any known history of myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
No Placebo-Only Group

Summary

This trial is studying how well niraparib works in treating patients with pancreatic cancer.

Who is the study for?
This trial is for adults with advanced pancreatic cancer who've had at least one prior treatment. They must have measurable disease, be in good physical condition (ECOG 0 or 1), and have proper organ function. Women of childbearing potential must test negative for pregnancy and agree to contraception; men also need to commit to using birth control. Participants can't join if they've recently received certain therapies, have specific blood disorders, are immunocompromised, or have untreated brain metastases.
What is being tested?
The study is testing Niraparib as a potential treatment for pancreatic cancer in patients who meet certain genetic criteria related to mutations in genes like BRCA1/2. It's an investigational therapy which means it hasn’t been approved yet for general use. Patients will take the oral medication and their response will be monitored over time.
What are the potential side effects?
While not explicitly listed here, common side effects of drugs similar to Niraparib may include nausea, fatigue, low blood cell counts leading to increased infection risk or bleeding problems, heartburn, and changes in liver function tests.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My cancer has specific genetic changes in BRCA1, BRCA2, PALB2, CHEK2, or ATM.
Select...
I am 18 years old or older.
Select...
I can swallow and keep down pills.
Select...
My pancreatic cancer cannot be cured with standard treatments.
Select...
I am fully active or can carry out light work.
Select...
My blood tests show my organs and bone marrow are working well.
Select...
I am willing to have a new biopsy before treatment starts.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have had another type of cancer in the last 2 years.
Select...
I have never been diagnosed with MDS or AML.
Select...
I do not have any serious ongoing illnesses that could interfere with the study.
Select...
I have brain metastases that have not been treated.
Select...
I had major surgery less than 3 weeks ago.
Select...
I have been treated with a PARP inhibitor before.
Select...
I haven't had significant radiation therapy affecting my bone marrow recently.
Select...
I do not have HIV.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Progression Free Survival
Secondary study objectives
Overall Survival Rate

Side effects data

From 2022 Phase 2 trial • 37 Patients • NCT03207347
74%
Fatigue
52%
Nausea
39%
Constipation
39%
Anorexia
30%
Anemia
30%
Alkaline phosphatase increased
26%
Weight loss
22%
Abdominal pain
22%
Dizziness
22%
Insomnia
22%
Dyspnea
17%
Headache
17%
Mucositis oral
17%
Platelet count decreased
17%
Creatinine increased
13%
Vomiting
13%
Rash maculo-papular
13%
Aspartate aminotransferase increased
13%
Sinus tachycardia
9%
Cough
9%
Dehydration
9%
Urinary tract infection
9%
Dry mouth
9%
Hypertension
9%
Non-cardiac chest pain
9%
Alanine aminotransferase increased
9%
Anxiety
9%
Blood bilirubin increased
9%
Back pain
4%
Upper respiratory infection
4%
Hoarseness
4%
Hypotension
4%
Hot flashes
4%
Postnasal drip
4%
Head injury
4%
Hypokalemia
4%
Hyponatremia
4%
Flu like symptoms
4%
Skin tear
4%
Hyperglycemia
4%
Neutrophil count decreased
4%
Tremor
4%
Bruising
4%
Esophageal ulcer
4%
Diarrhea
4%
Depression
4%
Itchy eyes
4%
Oral petechia
4%
Edema limbs
4%
Hyperkalemia
4%
Peripheral sensory neuropathy
4%
Leukocytosis
4%
White blood cell decreased
4%
Lung infection
4%
Bloating
4%
Unknown infection
4%
Hematuria
4%
Ascites
4%
Sinus pain
4%
Sore throat
4%
Syncope
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cohort A
Cohort B

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: NiraparibExperimental Treatment1 Intervention
* Niraparib will be administered orally once daily * Palliative radiation therapy to a small field \>1 week prior to Day 1 of study treatment
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Niraparib
2018
Completed Phase 4
~2400

Find a Location

Who is running the clinical trial?

Dana-Farber Cancer InstituteLead Sponsor
1,108 Previous Clinical Trials
357,006 Total Patients Enrolled
Tesaro, Inc.Industry Sponsor
56 Previous Clinical Trials
10,524 Total Patients Enrolled
James Cleary, MD, PhD5.02 ReviewsPrincipal Investigator - Dana-Farber Cancer Institute
Dana-Farber Cancer Institute
4 Previous Clinical Trials
112 Total Patients Enrolled
5Patient Review
He is very caring and compassionate. He walks his patients through every step of the process.

Media Library

Niraparib (PARP Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03601923 — Phase 2
Pancreatic Cancer Research Study Groups: Niraparib
Pancreatic Cancer Clinical Trial 2023: Niraparib Highlights & Side Effects. Trial Name: NCT03601923 — Phase 2
Niraparib (PARP Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03601923 — Phase 2
~3 spots leftby Sep 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top