Niraparib for Sarcoma Uterus

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Memorial Sloan Kettering Nassau (Limited Protocol Activities), Uniondale, NY
Sarcoma Uterus+2 More
Niraparib - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

The purpose of this study is to test whether the study drug, niraparib, is effective against unresectable and/or metastatic soft tissue sarcoma with DDR mutations. The researchers will also study whether niraparib is safe and causes few or mild side effects, and whether there are groups of DDR mutations in soft tissue sarcoma cells that respond better to treatment with niraparib.

Eligible Conditions

  • Sarcoma Uterus
  • Soft Tissue Sarcoma (STS)

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Sarcoma Uterus

Study Objectives

0 Primary · 2 Secondary · Reporting Duration: 2 years

2 years
Assess adverse events
24 weeks
Progression free survival (PFS)

Trial Safety

Safety Progress

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

Other trials for Sarcoma Uterus

Side Effects for

Stage 1 (Cohort 2): Niraparib + Pembrolizumab
57%Nausea
52%Decreased appetite
48%Anaemia
48%Constipation
43%Fatigue
38%Dyspnoea
24%Oedema peripheral
24%Vomiting
24%Stomatitis
24%Platelet count decreased
19%Insomnia
19%Blood alkaline phosphatase increased
19%Arthralgia
19%Pruritus
14%Pneumonia
14%Diarrhoea
14%Cough
14%Pain
14%Chills
14%Upper respiratory tract infection
14%Weight decreased
14%Neutrophil count decreased
14%Dysgeusia
14%Back pain
14%Muscular weakness
10%Depression
10%Erythema
10%Vision blurred
10%Pleural effusion
10%Atrial fibrillation
10%Neuropathy peripheral
10%Haemorrhoids
10%Haemorrhoidal haemorrhage
10%Anxiety
10%Proctalgia
10%Oropharyngeal pain
10%Wheezing
10%Non-cardiac chest pain
10%Productive cough
10%Gait disturbance
10%Chest pain
10%Urinary tract infection
10%Hypophosphataemia
10%Aspartate aminotransferase increased
10%Dehydration
10%Blood creatinine increased
10%Hypokalaemia
10%Lymphocyte count decreased
10%Alanine aminotransferase increased
10%Rash maculo-papular
10%Pain of skin
10%Overdose
10%Hypothyroidism
5%Dysphonia
5%Sinus tachycardia
5%Angina pectoris
5%Neuroendocrine carcinoma of the skin
5%Gastrooesophageal reflux disease
5%Candida infection
5%Sepsis
5%Dizziness
5%Fall
5%Pulmonary embolism
5%Pneumonitis
5%Respiratory failure
5%Cardiac arrest
5%Pericardial effusion
5%Intestinal obstruction
5%Lactic acidosis
5%Diverticulitis
5%Lethargy
5%Headache
5%Cancer pain
5%Toxicity to various agents
5%Abdominal pain
5%Haematochezia
5%Nasal congestion
5%Asthenia
5%Pyrexia
5%Malaise
5%Hypomagnesaemia
5%Hyponatraemia
5%Amylase increased
5%Hepatic enzyme increased
5%Peripheral sensory neuropathy
5%Pain in extremity
5%Hyperhidrosis
5%Tachycardia
5%Contusion
5%Hypotension
5%Lipase increased
5%Syncope
5%Hyperglycaemia
0%Chronic obstructive pulmonary disease
0%Pleural infection
0%Hepatobiliary disease
0%Sinusitis
0%Tinnitus
0%Cholelithiasis
0%Pneumothorax
0%Myocardial infarction
0%Orthopnoea
0%Hot flush
0%Mental status changes
0%Levator syndrome
0%Thrombocytopenia
0%Haemoglobin decreased
0%Glycosylated haemoglobin increased
0%Haemoptysis
0%Catheter site abscess
0%Lymphadenitis
0%Neuralgia
0%Confusional state
0%Peroneal nerve palsy
0%Agitation
0%Flank pain
0%Dry skin
0%Ecchymosis
0%Atrial flutter
0%Cardiac failure congestive
0%Ankle fracture
0%Penile pain
0%Clostridium difficile colitis
0%Neutropenia
0%Physical deconditioning
0%Hyperamylasaemia
0%Hypercalcaemia
0%Taste disorder
0%Restless legs syndrome
0%Night sweats
0%Skin ulcer
0%Joint swelling
0%Musculoskeletal pain
0%Superior vena cava syndrome
0%Flushing
0%Vertigo positional
0%Facial paralysis
0%Amnesia
0%Encephalopathy
0%Delirium
0%Pancreatitis acute
0%Ischaemic stroke
0%Cognitive disorder
0%Small intestinal obstruction
0%Psychotic disorder
0%Dizziness postural
0%Failure to thrive
0%Horner's syndrome
0%Colitis
0%Acute respiratory failure
0%Memory impairment
0%Dysphagia
0%Pancreatic failure
0%Dyspepsia
0%Hypoxia
0%Lip disorder
0%Rales
0%Rhinorrhoea
0%Tachypnoea
0%Nasopharyngitis
0%Fungal infection
0%Bacteraemia
0%Mucosal infection
0%Oral candidiasis
0%Viral infection
0%Malnutrition
0%Thrombocytosis
0%Blood magnesium decreased
0%Vitamin D decreased
0%Rash
0%Decubitus ulcer
0%Rash papular
0%Skin hypopigmentation
0%Arthropod sting
0%Bladder spasm
0%Dysuria
0%Haematuria
0%Incontinence
0%Renal failure
0%Hypertension
0%Urinary incontinence
0%Urinary tract pain
0%Haematoma
0%Vertigo
0%Benign prostatic hyperplasia
0%Calculus prostatic
0%Prostatic pain
0%Immobile
0%Cholecystectomy
0%Pollakiuria
0%Catheter site pain
0%Abdominal pain upper
0%Catheter site irritation
0%Aphasia
0%Alopecia
0%Acute kidney injury
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%, Anaemia with 48%, Constipation with 48%, Fatigue with 43%.

Trial Design

1 Treatment Group

Niraparib
1 of 1
Experimental Treatment

32 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
2017
Completed Phase 2
~790

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 2 years
Closest Location: Memorial Sloan Kettering Nassau (Limited Protocol Activities) · Uniondale, NY
Photo of new york 1Photo of new york 2Photo of new york 3
N/AFirst Recorded Clinical Trial
1 TrialsResearching Sarcoma Uterus
0 CompletedClinical Trials

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor
1,806 Previous Clinical Trials
589,296 Total Patients Enrolled
GlaxoSmithKlineIndustry Sponsor
4,621 Previous Clinical Trials
7,937,051 Total Patients Enrolled
William Tap, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
6 Previous Clinical Trials
752 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have confirmed the presence of a gene pathway.
You or your LAR are willing to provide written informed consent/assent for the trial.
You have histologically confirmed unresectable or metastatic soft tissue or uterine sarcoma.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.