Niraparib for Melanoma

California Pacific Medical Center Research Institute, San Francisco, CA
MelanomaNiraparib - Drug
Eligibility
18+
All Sexes

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

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
Phase 2

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1
Niraparib
1
Niraparib
1
Nivolumab

Study Objectives

1 Primary · 3 Secondary · Reporting Duration: 2 years

2 years
Number of Participants With Adverse Events as a Measure of Safety and Tolerability
Progression-free survival (PFS)
overall survival (OS)
6 months
Objective Response Rate (ORR)

Trial Safety

Phase-Based Safety

2 of 3
This is further along than 68% of similar trials

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1
Niraparib
1
Niraparib
1
Nivolumab

Side Effects for

Stage 1 (Cohort 2): Niraparib + Pembrolizumab
57%Nausea
52%Decreased appetite
48%Constipation
48%Anaemia
43%Fatigue
38%Dyspnoea
24%Vomiting
24%Platelet count decreased
24%Oedema peripheral
24%Stomatitis
19%Blood alkaline phosphatase increased
19%Insomnia
19%Arthralgia
19%Pruritus
14%Cough
14%Dysgeusia
14%Weight decreased
14%Diarrhoea
14%Chills
14%Pneumonia
14%Pain
14%Upper respiratory tract infection
14%Neutrophil count decreased
14%Back pain
14%Muscular weakness
10%Productive cough
10%Wheezing
10%Haemorrhoids
10%Gait disturbance
10%Urinary tract infection
10%Non-cardiac chest pain
10%Alanine aminotransferase increased
10%Chest pain
10%Proctalgia
10%Pleural effusion
10%Atrial fibrillation
10%Haemorrhoidal haemorrhage
10%Oropharyngeal pain
10%Dehydration
10%Hypokalaemia
10%Hypophosphataemia
10%Aspartate aminotransferase increased
10%Blood creatinine increased
10%Lymphocyte count decreased
10%Neuropathy peripheral
10%Anxiety
10%Depression
10%Rash maculo-papular
10%Erythema
10%Pain of skin
10%Overdose
10%Hypothyroidism
10%Vision blurred
5%Haematochezia
5%Candida infection
5%Contusion
5%Toxicity to various agents
5%Hyponatraemia
5%Angina pectoris
5%Fall
5%Diverticulitis
5%Tachycardia
5%Gastrooesophageal reflux disease
5%Dizziness
5%Cancer pain
5%Dysphonia
5%Peripheral sensory neuropathy
5%Neuroendocrine carcinoma of the skin
5%Pulmonary embolism
5%Sepsis
5%Hepatic enzyme increased
5%Lipase increased
5%Pneumonitis
5%Respiratory failure
5%Cardiac arrest
5%Pericardial effusion
5%Intestinal obstruction
5%Lactic acidosis
5%Abdominal pain
5%Nasal congestion
5%Pyrexia
5%Asthenia
5%Malaise
5%Hypomagnesaemia
5%Amylase increased
5%Headache
5%Lethargy
5%Pain in extremity
5%Hyperhidrosis
5%Sinus tachycardia
5%Hypotension
5%Syncope
5%Hyperglycaemia
This histogram enumerates side effects from a completed 2021 Phase 2 trial (NCT03308942) in the Stage 1 (Cohort 2): Niraparib + Pembrolizumab ARM group. Side effects include: Nausea with 57%, Decreased appetite with 52%, Constipation with 48%, Anaemia with 48%, Fatigue with 43%.

Awards & Highlights

No Placebo Group
All patients enrolled in this trial will receive the new treatment.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Trial Design

1 Treatment Group

Niraparib
1 of 1

Experimental Treatment

41 Total Participants · 1 Treatment Group

Primary Treatment: Niraparib · No Placebo Group · Phase 2

Niraparib
Drug
Experimental Group · 1 Intervention: Niraparib · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Niraparib
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 2 years

Who is running the clinical trial?

Tesaro, Inc.Industry Sponsor
56 Previous Clinical Trials
10,638 Total Patients Enrolled
2 Trials studying Melanoma
60 Patients Enrolled for Melanoma
California Pacific Medical Center Research InstituteLead Sponsor
41 Previous Clinical Trials
11,583 Total Patients Enrolled
5 Trials studying Melanoma
117 Patients Enrolled for Melanoma
Vanderbilt-Ingram Cancer CenterOTHER
204 Previous Clinical Trials
59,873 Total Patients Enrolled
11 Trials studying Melanoma
3,196 Patients Enrolled for Melanoma
Huntsman Cancer InstituteOTHER
11 Previous Clinical Trials
7,506 Total Patients Enrolled
1 Trials studying Melanoma
Kevin Kim, MD4.47 ReviewsPrincipal Investigator - California Pacific Medical Center
California Pacific Medical Center Research Institute
2 Previous Clinical Trials
162 Total Patients Enrolled
2 Trials studying Melanoma
162 Patients Enrolled for Melanoma
5Patient Review
Dr. Kim is a wonderful doctor who always takes the time to listen to his patients. I was diagnosed with melanoma in 2002 and he was very kind and calming throughout my treatment. Sandra Butler, Houston, TX

Eligibility Criteria

Age 18+ · All Participants · 6 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
References

Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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