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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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights

Study 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.Check my eligibility
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.See study design
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
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My cancer has specific genetic changes in BRCA1, BRCA2, PALB2, CHEK2, or ATM.
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I am 18 years old or older.
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I agree to use birth control from the start of the study until 6 months after it ends.
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I can swallow and keep down pills.
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My pancreatic cancer cannot be cured with standard treatments.
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I have been on a stable dose of corticosteroids for at least 4 weeks.
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I agree not to donate blood during and for 3 months after the study.
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I am fully active or can carry out light work.
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I am not pregnant and agree to avoid pregnancy during the study.
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My blood tests show my organs and bone marrow are working well.
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I have undergone at least one treatment for my cancer before.
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I am willing to have a new biopsy before treatment starts.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Progression Free Survival
Secondary outcome measures
Evaluation of the safety and tolerability of niraparib as assessed by the Common Terminology Criteria for Adverse Events (CTCAE)
Overall Survival Rate
Overall response rate will be measured by RECIST criteria.

Side effects data

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

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
~1540

Find a Location

Who is running the clinical trial?

Dana-Farber Cancer InstituteLead Sponsor
1,072 Previous Clinical Trials
340,374 Total Patients Enrolled
Tesaro, Inc.Industry Sponsor
56 Previous Clinical Trials
10,518 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the total cohort size for this research project?

"Affirmative, clinicaltrials.gov data reveals that this experiment is actively enrolling patients. It was originally opened on August 22nd 2018 and last updated April 11th 2022 - with a goal of 32 participants spread across 3 medical sites."

Answered by AI

Is this an unprecedented clinical trial?

"Since 2016, Myriad Genetics Inc. has sponsored research projects on Niraparib with the initial study in that year involving 733 participants. This drug was granted Phase 3 approval and currently there are 99 active investigations into its effects across 485 cities of 49 nations worldwide."

Answered by AI

Is the enrolment period for this test still open?

"According to clinicaltrials.gov, this research study is currently accepting participants - it was initially posted on August 22nd 2018 and most recently revised on April 11th 2022."

Answered by AI

Could you give me a summary of previous experiments utilizing Niraparib?

"Presently, 99 ongoing studies are exploring the potential of Niraparib with 13 being in Phase 3. While concentrations of research can be found in Washington, DC, 2817 separate sites are conducting experiments involving this drug."

Answered by AI

To what extent might Niraparib pose a danger to those taking it?

"Although no clinical data is currently available to support the intervention's efficacy, our team at Power has assessed Niraparib as being of medium safety (2/3) due its Phase 2 trial status."

Answered by AI
~3 spots leftby Sep 2024