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PARP Inhibitor
Niraparib for Pancreatic Cancer
Boston, MA
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.
See full description
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 belowSelect...
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 can swallow and keep down pills.
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My pancreatic cancer cannot be cured with standard treatments.
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I am fully active or can carry out light work.
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My blood tests show my organs and bone marrow are working well.
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I am willing to have a new biopsy before treatment starts.
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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.
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I have never been diagnosed with MDS or AML.
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I do not have any serious ongoing illnesses that could interfere with the study.
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I have brain metastases that have not been treated.
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I had major surgery less than 3 weeks ago.
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I have been treated with a PARP inhibitor before.
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I haven't had significant radiation therapy affecting my bone marrow recently.
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I do not have HIV.
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Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
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 • NCT0320734774%
Fatigue
52%
Nausea
39%
Constipation
39%
Anorexia
30%
Alkaline phosphatase increased
30%
Anemia
26%
Weight loss
22%
Abdominal pain
22%
Dyspnea
22%
Insomnia
22%
Dizziness
17%
Headache
17%
Mucositis oral
17%
Platelet count decreased
17%
Creatinine increased
13%
Aspartate aminotransferase increased
13%
Vomiting
13%
Rash maculo-papular
13%
Sinus tachycardia
9%
Alanine aminotransferase increased
9%
Back pain
9%
Blood bilirubin increased
9%
Cough
9%
Dehydration
9%
Dry mouth
9%
Hypertension
9%
Non-cardiac chest pain
9%
Urinary tract infection
9%
Anxiety
4%
Hypokalemia
4%
Hyperkalemia
4%
Bloating
4%
Bruising
4%
Diarrhea
4%
Esophageal ulcer
4%
Oral petechia
4%
Hoarseness
4%
Hot flashes
4%
Hyponatremia
4%
Hypotension
4%
Neutrophil count decreased
4%
Postnasal drip
4%
Sinus pain
4%
Sore throat
4%
Syncope
4%
Tremor
4%
Hematuria
4%
Itchy eyes
4%
Leukocytosis
4%
Head injury
4%
Hyperglycemia
4%
Upper respiratory infection
4%
White blood cell decreased
4%
Unknown infection
4%
Lung infection
4%
Ascites
4%
Depression
4%
Edema limbs
4%
Flu like symptoms
4%
Peripheral sensory neuropathy
4%
Skin tear
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
~2630
Find a Location
Closest Location:Massachusetts General Hospital· Boston, MA
Who is running the clinical trial?
Dana-Farber Cancer InstituteLead Sponsor
1,126 Previous Clinical Trials
361,142 Total Patients Enrolled
Tesaro, Inc.Industry Sponsor
56 Previous Clinical Trials
10,530 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a stomach or intestine problem that could affect how I absorb medication.My cancer has specific genetic changes in BRCA1, BRCA2, PALB2, CHEK2, or ATM.I am 18 years old or older.I agree to use birth control from the start of the study until 6 months after it ends.I can swallow and keep down pills.I have not recently had chemotherapy, radiotherapy, immunotherapy, or experimental treatments.You have had a bad reaction to drugs similar to niraparib.I have had another type of cancer in the last 2 years.I have never been diagnosed with MDS or AML.My pancreatic cancer cannot be cured with standard treatments.I have been on a stable dose of corticosteroids for at least 4 weeks.I agree not to donate blood during and for 3 months after the study.I have taken oral cancer treatment or TKI therapy recently.I haven't had a blood transfusion in the last 4 weeks.I do not have any serious ongoing illnesses that could interfere with the study.I am not on blood thinners, or my doctor can pause them for a biopsy.I have had severe blood-related side effects from my last chemotherapy that lasted more than 4 weeks.I am fully active or can carry out light work.I am not pregnant and agree to avoid pregnancy during the study.My blood tests show my organs and bone marrow are working well.You need to have a specific amount of detectable disease according to certain guidelines.I have brain metastases that have not been treated.I had major surgery less than 3 weeks ago.I have been treated with a PARP inhibitor before.I haven't had significant radiation therapy affecting my bone marrow recently.I have undergone at least one treatment for my cancer before.I don't have any health issues that would affect the study or stop me from completing it.I am willing to have a new biopsy before treatment starts.I haven't taken any colony stimulating factors in the last 4 weeks.I do not have HIV.
Research Study Groups:
This trial has the following groups:- Group 1: Niraparib
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.