← Back to Search

PARP Inhibitor

Niraparib for Melanoma

Phase 2
Waitlist Available
Led By Kevin Kim, MD
Research Sponsored by California Pacific Medical Center Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
ECOG PS >/=1
Have genetic homologous recombination (HR) mutation/ alteration including ARID1A/B, ARID2, ATM, ATR, ATRX, BARD1, BRCA1/2, BAP1, BRIP1, CHEK2, FANCD2, MRN11A, PALB2, RAD50, RAD51, RAD54B
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 advanced melanoma that has progressed after other treatments.

Eligible Conditions
  • Metastatic Melanoma

Eligibility Criteria

Inclusion Criteria

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

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
Objective Response Rate (ORR)
Secondary outcome measures
Number of Participants With Adverse Events as a Measure of Safety and Tolerability
Progression-free survival (PFS)
overall survival (OS)

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%
Dyspnea
22%
Abdominal pain
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%
Anxiety
9%
Alanine aminotransferase increased
9%
Dehydration
9%
Blood bilirubin increased
9%
Urinary tract infection
9%
Dry mouth
9%
Back pain
9%
Cough
9%
Hypertension
9%
Non-cardiac chest pain
4%
Esophageal ulcer
4%
Skin tear
4%
Diarrhea
4%
Edema limbs
4%
Leukocytosis
4%
Syncope
4%
Oral petechia
4%
Sinus pain
4%
Unknown infection
4%
Ascites
4%
Bruising
4%
Itchy eyes
4%
Flu like symptoms
4%
Hoarseness
4%
Peripheral sensory neuropathy
4%
Sore throat
4%
Upper respiratory infection
4%
Neutrophil count decreased
4%
Lung infection
4%
White blood cell decreased
4%
Hypotension
4%
Hyponatremia
4%
Hypokalemia
4%
Depression
4%
Head injury
4%
Postnasal drip
4%
Hyperkalemia
4%
Bloating
4%
Hot flashes
4%
Hyperglycemia
4%
Hematuria
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
Patients receive niraparib PO daily
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Niraparib
FDA approved

Find a Location

Who is running the clinical trial?

Huntsman Cancer InstituteOTHER
12 Previous Clinical Trials
7,598 Total Patients Enrolled
1 Trials studying Melanoma
California Pacific Medical Center Research InstituteLead Sponsor
43 Previous Clinical Trials
12,485 Total Patients Enrolled
5 Trials studying Melanoma
117 Patients Enrolled for Melanoma
Tesaro, Inc.Industry Sponsor
56 Previous Clinical Trials
10,515 Total Patients Enrolled
2 Trials studying Melanoma
60 Patients Enrolled for Melanoma

Frequently Asked Questions

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

What are the precedent studies for Niraparib?

"Currently, 96 clinical trials for Niraparib are active with 13 of them in Phase 3. While some of the research is based out of Washington D.C., there are 2645 total facilities conducting these studies."

Answered by AI

Are there still enrollees needed for this clinical trial?

"As of 10/15/2021, this study detailed on clinicaltrials.gov is still searching for individuals to participate. The original posting date was 3/20/2019."

Answered by AI

Has the United States Food and Drug Administration cleared Niraparib for use?

"Niraparib's safety was given a score of 2. This is because, although Phase 2 trials offer some data suggesting that the drug is safe, there are no such studies yet which confirm its efficacy."

Answered by AI

How many individuals are involved in this experiment?

"That is correct, the listing on clinicaltrials.gov affirms that this research project is actively looking for volunteers. The trial was first posted on March 20th, 2019 and updated as recently as October 15th, 2021. A total of 41 individuals are needed across 1 locations."

Answered by AI

Does this clinical trial break new ground?

"Niraparib has had 96 clinical trials thus far, with the first taking place in 2016. Myriad Genetics, Inc. sponsored the initial study which 733 people took part in. It completed Phase 3 and was approved for drugs. Since then, 17 more studies have been conducted."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Efficacy and Safety Study of Niraparib in Melanoma With Genetic Homologous Recombination (HR) Mutation
Kevin Kim 2019. "Efficacy and Safety Study of Niraparib in Melanoma With Genetic Homologous Recombination (HR) Mutation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03925350.
~7 spots leftby Apr 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