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Tyrosine Kinase Inhibitor
Nilotinib for Giant Cell Tumor
Phase 2
Waitlist Available
Research Sponsored by Andrew J. Wagner, MD, PhD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
18 years of age or older
ECOG Performance Status of 0, 1 or 2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
Study Summary
This trial is testing whether the drug nilotinib can stop the growth of a blood cancer called pigmented villonodular synovitis, or improve symptoms experienced from the disease.
Who is the study for?
Adults with progressive pigmented villonodular synovitis (PVNS) or related tumors, who haven't responded to other treatments and can't have surgery. Participants need good organ function, a life expectancy over 6 months, measurable disease on scans, and must be able to perform daily activities with minimal assistance. They should not be pregnant or breastfeeding and must use contraception.Check my eligibility
What is being tested?
The trial is testing Nilotinib's effectiveness against PVNS/tumors that are either growing back after treatment or spreading. It blocks proteins that may cause tumor growth. The study will see if it can halt tumor progression or relieve symptoms.See study design
What are the potential side effects?
Nilotinib may cause heart problems like irregular heartbeat, pancreas inflammation, liver issues, bleeding disorders unrelated to cancer, severe drug interactions especially with CYP3A4 inhibitors which could affect the heart rhythm.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Select...
I can care for myself and am up and about more than 50% of my waking hours.
Select...
I have at least one tumor that can be measured on a scan.
Select...
I have a confirmed diagnosis of PVNS that cannot be surgically removed, has spread, or I refuse surgery.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Percentage of Participants With Progression Free Survival
Secondary outcome measures
Clinical Benefit Rate
Overall Tumor Response Rate (OR)
Side effects data
From 2019 Phase 3 trial • 846 Patients • NCT0047149745%
Rash
38%
Headache
32%
Nausea
31%
Alanine aminotransferase increased
24%
Diarrhoea
24%
Nasopharyngitis
24%
Upper respiratory tract infection
23%
Arthralgia
23%
Back pain
22%
Vomiting
22%
Abdominal pain upper
22%
Cough
21%
Alopecia
21%
Thrombocytopenia
20%
Hypertension
20%
Fatigue
20%
Hypophosphataemia
20%
Myalgia
20%
Pruritus
19%
Constipation
19%
Hyperbilirubinaemia
19%
Pain in extremity
18%
Influenza
18%
Pyrexia
17%
Abdominal pain
16%
Oedema peripheral
16%
Anaemia
16%
Aspartate aminotransferase increased
15%
Blood bilirubin increased
14%
Hypercholesterolaemia
14%
Dry skin
14%
Muscle spasms
14%
Lipase increased
14%
Musculoskeletal pain
13%
Dyspepsia
13%
Insomnia
12%
Dizziness
11%
Neutropenia
11%
Dyspnoea
10%
Asthenia
10%
Oropharyngeal pain
10%
Sinusitis
10%
Urinary tract infection
10%
Bone pain
10%
Hyperglycaemia
9%
Non-cardiac chest pain
8%
Decreased appetite
8%
Leukopenia
8%
Amylase increased
8%
Weight increased
8%
Dry eye
8%
Gastroenteritis
8%
Anxiety
7%
Haemorrhoids
7%
Bronchitis
7%
Palpitations
6%
Blood alkaline phosphatase increased
6%
Gastrooesophageal reflux disease
6%
Pharyngitis
6%
Conjunctivitis
6%
Folliculitis
6%
Hyperhidrosis
6%
Erythema
6%
Night sweats
6%
Depression
6%
Gastritis
5%
Flatulence
5%
Chills
5%
Blood cholesterol increased
5%
Influenza like illness
5%
Blood phosphorus decreased
5%
Haemoglobin decreased
5%
Procedural pain
5%
Hyperlipidaemia
5%
Abdominal distension
5%
Hyperuricaemia
5%
Vertigo
5%
Weight decreased
4%
Coronary artery disease
4%
Toothache
4%
Blood creatinine increased
4%
Hypoaesthesia
4%
Angina pectoris
4%
Neck pain
4%
Hypokalaemia
4%
Eczema
4%
Paraesthesia
3%
Face oedema
3%
Herpes zoster
2%
Myocardial infarction
2%
Pneumonia
2%
Transient ischaemic attack
2%
Conjunctival haemorrhage
2%
Acute myocardial infarction
2%
Eyelid oedema
2%
Peripheral arterial occlusive disease
1%
Intestinal obstruction
1%
Angina unstable
1%
Pilonidal cyst
1%
Inguinal hernia
1%
Death
1%
Cellulitis
1%
Migraine
1%
Cerebral haemorrhage
1%
Periorbital oedema
1%
Neuropathy peripheral
1%
Azotaemia
1%
Peripheral artery stenosis
1%
Coronary artery stenosis
1%
Carotid artery stenosis
1%
Renal failure
1%
Benign prostatic hyperplasia
1%
Febrile neutropenia
1%
Gastrointestinal haemorrhage
1%
Myocardial ischaemia
1%
Pancreatitis
1%
Atrial fibrillation
1%
Pancreatitis acute
1%
Hepatic function abnormal
1%
Sepsis
1%
Femur fracture
1%
Road traffic accident
1%
Cerebrovascular accident
1%
Ischaemic stroke
100%
80%
60%
40%
20%
0%
Study treatment Arm
Nilotinib 400 mg BID
Imatinib 400 mg QD
All Patients
Nilotinib 300 mg BID
Trial Design
1Treatment groups
Experimental Treatment
Group I: NilotinibExperimental Treatment1 Intervention
Nilotinib 200 mg taken as 400 mg twice daily, continuously
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
nilotinib
2009
Completed Phase 4
~4140
Find a Location
Who is running the clinical trial?
Andrew J. Wagner, MD, PhDLead Sponsor
Brigham and Women's HospitalOTHER
1,608 Previous Clinical Trials
11,469,860 Total Patients Enrolled
Massachusetts General HospitalOTHER
2,928 Previous Clinical Trials
13,198,338 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I cannot undergo MRI scans due to health reasons.I am 18 years old or older.I can care for myself and am up and about more than 50% of my waking hours.I have not taken drugs like nilotinib or imatinib for a giant cell tumor.I have liver disease.I am not on medication that affects heart rhythm or can't switch before the study.I have a stomach or intestine problem that affects how I absorb medicine.I do not have another cancer that needs treatment.I have a confirmed diagnosis of PVNS that cannot be surgically removed, has spread, or I refuse surgery.My organs and bone marrow are functioning normally.I agree to use birth control during and for 3 months after the study.I have a history of serious bleeding problems not related to cancer.I am not pregnant or breastfeeding.I have at least one tumor that can be measured on a scan.I have had treatments before, but not with CSF1 receptor inhibitors.I am currently on a strong medication that cannot be stopped or changed before starting the study drug.I have not had major surgery in the last 28 days.I have a pancreatic disease.My heart does not function properly.
Research Study Groups:
This trial has the following groups:- Group 1: Nilotinib
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this an unprecedented clinical trial?
"Presently, 35 active studies of nilotinib are being conducted in 42 nations and 566 cities. These trials have their origins with a Phase 4 Novartis Pharmaceuticals-sponsored clinical study that began back in 2008 and included 34 participants. Since then, 79 experiments utilizing the medication have been concluded."
Answered by AI
What is the aggregate figure of participants in this clinical experiment?
"This experiment has reached its patient enrolment limit and is no longer actively recruiting. It was first publicized on September 1st 2010, with the last update occurring July 25th 2022. For those still looking to participate in a trial related to synovitis, pigmented villonodular or nilotinib-based treatments, there are currently 2390 and 35 studies admitting patients respectively."
Answered by AI
What potential risks should be considered when administering nilotinib to individuals?
"Although there is some evidence of nilotinib's safety, the absence of clinical data regarding efficacy awarded it a score 2 on Power's scale."
Answered by AI
What other research projects have utilized nilotinib as a key component?
"Currently, 35 active clinical trials are examining nilotinib with 6 studies in their final testing stages. Fukuoka city holds the majority of these trials, while other cities around the world have 1548 sites devoted to investigating this medication."
Answered by AI
How many healthcare centers are conducting this research project?
"This medical trial is being conducted in 11 centres, with three of the more prominent ones located at Dana-Farber Cancer Institute (Stanford, California), Stanford University Medical Center (Houston, Texas), and UT MD Anderson Cancer Center (Santa Monica, Florida)."
Answered by AI
Is the enrollment process for this trial still ongoing?
"Data on clinicialtrials.gov shows that this medical experiment is no longer actively seeking participants; the trial was initially posted in September 2010 and last modified in July 2022. Even if they are not currently enrolling, there remain 2,425 other trials open to applicants at present."
Answered by AI
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