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PARP Inhibitor

Niraparib for Cancer (PAVO Trial)

Phase 2
Waitlist Available
Research Sponsored by Tempus Labs
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participants must have tested positive for a pathogenic or likely pathogenic tPALB2 gene mutation using a CLIA-certified laboratory as described in the Next-Generation Sequencing (NGS) Laboratory Manual.
Participants must have a histologically or cytologically confirmed diagnosis of locally advanced or metastatic solid tumor(s).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 4 years
Awards & highlights

PAVO Trial Summary

This trial will help researchers learn more about how effective niraparib is for treating solid tumors with a PALB2 mutation.

Who is the study for?
This trial is for adults with advanced solid tumors and a specific gene mutation called tPALB2. They should have tried all standard treatments or be unsuitable for them, and not have other cancers needing systemic treatment. Participants can't join if they've had certain recent treatments, previous PARP inhibitors, ovarian/prostate cancer, high blood pressure uncontrolled by medication, or specific genetic mutations.Check my eligibility
What is being tested?
The study tests the effectiveness and safety of Niraparib in patients with various types of advanced cancers like breast, lung, colorectal etc., who carry the PALB2 mutation. It's aimed at those whose disease has progressed despite standard therapies or who cannot tolerate such treatments.See study design
What are the potential side effects?
Niraparib may cause side effects including nausea, fatigue, low blood cell counts leading to increased infection risk or bleeding problems, heart palpitations, insomnia and constipation. Some people might experience changes in liver function tests.

PAVO Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have a confirmed PALB2 gene mutation.
Select...
My cancer is advanced or has spread and was confirmed by a lab test.
Select...
I am 18 years old or older.

PAVO Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 4 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 4 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
Overall Response Rate (ORR) - Independent Central Review (ICR)
Secondary outcome measures
Clinical Benefit Rate (CBR) - Investigator and ICR
Duration of Response (DOR) - Independent Central Review (ICR)
Duration of Response (DOR) - Investigator
+7 more

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

PAVO Trial Design

1Treatment groups
Experimental Treatment
Group I: Niraparib in Locally Advanced or Metastatic Solid Tumor Patients with PALB2 MutationsExperimental Treatment1 Intervention
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?

Tempus LabsLead Sponsor
16 Previous Clinical Trials
18,017 Total Patients Enrolled
Tempus AILead Sponsor
16 Previous Clinical Trials
17,517 Total Patients Enrolled
GlaxoSmithKlineIndustry Sponsor
4,763 Previous Clinical Trials
8,104,745 Total Patients Enrolled

Media Library

Niraparib (PARP Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05169437 — Phase 2
Colorectal Cancer Research Study Groups: Niraparib in Locally Advanced or Metastatic Solid Tumor Patients with PALB2 Mutations
Colorectal Cancer Clinical Trial 2023: Niraparib Highlights & Side Effects. Trial Name: NCT05169437 — Phase 2
Niraparib (PARP Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05169437 — Phase 2

Frequently Asked Questions

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

What other similar trials exist for this medication?

"Research into niraparib began in 2016 with the first clinical trial. Myriad Genetics, Inc. sponsored this initial study of 733 people that took place in 2016. After successful completion, niraparib received Phase 3 drug approval and sparked 96 active trials in 476 cities across 49 countries."

Answered by AI

Could you list any similar Niraparib clinical trials that have already taken place?

"Niraparib was first studied in 2016 by GSK. To date, a total of 17 clinical trials have been completed while 96 different ones are ongoing. There is a significant amount of research being done out of Fairfax, Virginia."

Answered by AI

What is the present-day status of Niraparib in terms of federal approval?

"There is some data indicating that Niraparib is safe, but none yet supporting its efficacy. It received a score of 2."

Answered by AI

How many people will be participating in this clinical trial at most?

"One hundred and ten patients that satisfy the study's requirements are necessary to carry out the research. The sponsor, GlaxoSmithKline, will be managing the trial from several locations like Inova Schar Institute in Fairfax, Virginia as well as Nebraska Cancer Specialists in Omaha, Nebraska."

Answered by AI

In how many different clinics is this study being run today?

"This trial has 76 enrolling patients at locations such as Inova Schar Institute in Fairfax, Nebraska Cancer Specialists in Omaha, and Texas Oncology - Paris Cancer Center in Paris."

Answered by AI

Are people with the required qualifications able to participate in this clinical trial right now?

"That is correct. The clinicaltrials.gov website lists this trial as recruiting patients. This study was originally posted on March 15th, 2022 and has been updated September 26th, 2022. They are looking for 110 individuals to fill the 76 different spots at various locations."

Answered by AI

Who else is applying?

What state do they live in?
Idaho
How old are they?
18 - 65
What site did they apply to?
PeaceHealth
The University of Texas Southwestern Medical Center
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Niraparib in the Treatment of Patients With Advanced PALB2 Mutated Tumors
2022. "Niraparib in the Treatment of Patients With Advanced PALB2 Mutated Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05169437.
All > Breast Cancer Dallas
~0 spots leftby Jun 2024
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