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Niraparib for Urologic Cancers

PeaceHealth, Bellingham, WA
Urologic Cancers+11 More ConditionsNiraparib - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

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

Eligible Conditions
  • Metastatic Cancer
  • Urologic Cancer
  • Locally Advanced Solid Tumors
  • Endometrial Cancer
  • Pancreatic Cancer
  • Solid Tumors
  • Breast Cancer
  • Head and Neck Cancer
  • Esophageal Cancer
  • Melanoma
  • Lung Cancer
  • Colorectal Cancer

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
Phase 2

Similar Trials

1
Niraparib
1
Niraparib
1
Alectinib

Study Objectives

1 Primary · 10 Secondary · Reporting Duration: Up to 4 years

Up to 4 years
Clinical Benefit Rate (CBR) - Investigator and ICR
Duration of Response (DOR) - Independent Central Review (ICR)
Duration of Response (DOR) - Investigator
Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)
ORR with untreated measurable CNS lesions - ICR
ORR with untreated measurable CNS lesions - Investigator
Overall Response Rate (ORR) - Independent Central Review (ICR)
Overall Response Rate (ORR) - Investigator
Overall Survival (OS)
Progression-Free Survival (PFS) - Independent Central Review (ICR)
Progression-Free Survival (PFS) - Investigator

Trial Safety

Phase-Based Safety

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

Similar Trials

1
Niraparib
1
Niraparib
1
Alectinib

Side Effects for

Stage 1 (Cohort 2): Niraparib + Pembrolizumab
57%Nausea
52%Decreased appetite
48%Constipation
48%Anaemia
43%Fatigue
38%Dyspnoea
24%Oedema peripheral
24%Platelet count decreased
24%Vomiting
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%Haemorrhoids
10%Gait disturbance
10%Wheezing
10%Chest pain
10%Urinary tract infection
10%Non-cardiac chest pain
10%Alanine aminotransferase increased
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%Candida infection
5%Haematochezia
5%Contusion
5%Neuroendocrine carcinoma of the skin
5%Toxicity to various agents
5%Hyponatraemia
5%Fall
5%Diverticulitis
5%Tachycardia
5%Angina pectoris
5%Gastrooesophageal reflux disease
5%Dizziness
5%Cancer pain
5%Dysphonia
5%Peripheral sensory neuropathy
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 in Locally Advanced or Metastatic Solid Tumor Patients with PALB2 Muta...
1 of 1

Experimental Treatment

110 Total Participants · 1 Treatment Group

Primary Treatment: Niraparib · No Placebo Group · Phase 2

Niraparib in Locally Advanced or Metastatic Solid Tumor Patients with PALB2 Mutations
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: up to 4 years

Who is running the clinical trial?

Tempus LabsLead Sponsor
11 Previous Clinical Trials
6,205 Total Patients Enrolled
GlaxoSmithKlineIndustry Sponsor
4,672 Previous Clinical Trials
7,956,961 Total Patients Enrolled
Anjali Avadhani, MDStudy DirectorTempus Labs, Inc.
2 Previous Clinical Trials
863 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 0 Total Inclusion Criteria

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

Who else is applying?

What state do they live in?
Idaho100.0%
How old are they?
18 - 65100.0%
What site did they apply to?
PeaceHealth100.0%
What portion of applicants met pre-screening criteria?
Met criteria100.0%
References

Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - 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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