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PARP Inhibitor

Niraparib for Mesothelioma

Phase 2
Waitlist Available
Led By Thomas George, MD, FACP
Research Sponsored by University of Florida
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age ≥18 years
Prior treatment with standard systemic therapy (must have exhausted or declined all known and currently approved effective life prolonging therapies)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights

Study Summary

This trial will look at whether niraparib can help treat patients with tumors that have mutations in BAP1 and other select genes involved in repairing DNA damage.

Eligible Conditions
  • Mesothelioma
  • Bile Duct Cancer
  • Uveal Melanoma
  • Kidney Cancer

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Objective Response Rate (ORR)
Secondary outcome measures
Overall Survival
Progression-Free Survival
Progression-Free Survival Rate at 3 Months
+1 more
Other outcome measures
Biomarker identification
Number of DNA repair mechanism deficiencies

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%
Creatinine increased
17%
Headache
17%
Platelet count decreased
17%
Mucositis oral
13%
Sinus tachycardia
13%
Vomiting
13%
Aspartate aminotransferase increased
13%
Rash maculo-papular
9%
Dehydration
9%
Back pain
9%
Urinary tract infection
9%
Blood bilirubin increased
9%
Anxiety
9%
Alanine aminotransferase increased
9%
Dry mouth
9%
Cough
9%
Hypertension
9%
Non-cardiac chest pain
4%
Skin tear
4%
Diarrhea
4%
Oral petechia
4%
Sinus pain
4%
Depression
4%
Esophageal ulcer
4%
Head injury
4%
Neutrophil count decreased
4%
Lung infection
4%
White blood cell decreased
4%
Hypokalemia
4%
Sore throat
4%
Unknown infection
4%
Ascites
4%
Bruising
4%
Peripheral sensory neuropathy
4%
Syncope
4%
Itchy eyes
4%
Leukocytosis
4%
Hyponatremia
4%
Flu like symptoms
4%
Edema limbs
4%
Postnasal drip
4%
Hypotension
4%
Hyperkalemia
4%
Hoarseness
4%
Bloating
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

2Treatment groups
Experimental Treatment
Group I: Cohort BExperimental Treatment1 Intervention
This cohort will enroll patients whose tumors have a known DNA damage response mutation in any of the following genes: ARID1A, ATM, ATR, BACH1 (BRIP1), BAP1, BARD1, BLM, CHEK1, CHEK2, CDK2, CDK4, ERCC, FAM175A, FEN1, IDH1, IDH2, MRE11A, NBN (NBS1), PALB2, POLD1, PRKDC (DNA-PK) PTEN, RAD50, RAD51, RAD52, RAD54, RPA1, SLX4, WRN, or XRCC. This cohort is open to patients with any type of malignancy (except prostate).
Group II: Cohort AExperimental Treatment1 Intervention
This cohort will enroll patients with mesothelioma, uveal melanoma, renal cell carcinoma (clear cell type), and cholangiocarcinoma.
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?

University of FloridaLead Sponsor
1,339 Previous Clinical Trials
717,318 Total Patients Enrolled
GlaxoSmithKlineIndustry Sponsor
4,749 Previous Clinical Trials
8,067,399 Total Patients Enrolled
1 Trials studying Mesothelioma
186 Patients Enrolled for Mesothelioma
Thomas George, MD, FACPPrincipal InvestigatorUniversity of Florida
2 Previous Clinical Trials
53 Total Patients Enrolled

Frequently Asked Questions

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

Have previous investigations been carried out on Niraparib?

"At the present time, 99 different clinical trials for Niraparib are being conducted. Of this number, 13 are in Phase 3. While mainly based in Washington D.C., there is a total of 2816 sites running these medical tests across America."

Answered by AI

Is the age range for qualified participants in this study inclusive of individuals over 35 years old?

"This investigation is open to individuals aged between 18 and 80. Meanwhile, 357 trials are available for minors while 3494 studies apply to those over 65 years old."

Answered by AI

Has Niraparib been sanctioned by the Food and Drug Administration?

"Our team at Power assessed Niraparib's safety as a 2, given that it is in the midst of Phase 2 trials and there has been some evidence collected regarding its safety, but none to indicate efficacy."

Answered by AI

Is this empirical research pioneering in nature?

"Presently, there are 99 experiments showcasing Niraparib in 485 cities across 49 nations. The first scientific trial for this drug was funded by Myriad Genetics, Inc. and involved 733 patients; it completed its Phase 3 approval stage back in 2016. Since then, a further 17 trials have been concluded successfully."

Answered by AI

Is there an opportunity for me to participate in this clinical experiment?

"This investigation is seeking 35 participants with cholangiocarcinoma aged between 18 and 80, who meet the following conditions: they must have a known DNA damage repair mutation including any one of ARID1A, ATM, ATR etc., possess measurable disease according to RECIST v 1.1 criteria, be rated 0-1 on ECOG Performance Status scale and possess life expectancy over 12 weeks; additionally, having formalin-fixed paraffin embedded tissue obtained up to 3 years ago from core or excisional biopsy is mandatory for research purposes. VUS results are acceptable in Cohort B only."

Answered by AI

Is the research actively recruiting participants?

"Contradictory to what is posted on clinicaltrials.gov, this particular medical research project is no longer actively searching for participants. Initially published in August of 2018 and last updated in December 2021, this trial has since ceased recruitment efforts; however there are still 3685 other medical studies that need volunteers now."

Answered by AI

What is the cap for enrolment in this clinical experiment?

"At present, this particular trial is not accepting patients. This research project was first published on August 13th 2018 and the most recent update occurred in December 2021. If you are searching for other studies related to cholangiocarcinoma or Niraparib, there are currently 3586 trials seeking volunteers and 99 trials actively recruiting participants respectively."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Trial of Niraparib in BAP1 and Other DNA Damage Response (DDR) Deficient Neoplasms (UF-STO-ETI-001)
2018. "A Trial of Niraparib in BAP1 and Other DNA Damage Response (DDR) Deficient Neoplasms (UF-STO-ETI-001)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03207347.
~6 spots leftby Apr 2025
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