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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
Must not have
Inability to tolerate or contraindication to MRI scanning for participants with localized disease
Prior treatment with known or suspected CSF1 receptor inhibitor, including nilotinib, imatinib, sunitinib, or sorafenib, or other approved or investigational tyrosine kinase inhibitors used for treatment of diffuse-type giant cell tumor
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
No Placebo-Only Group

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.
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.
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 below
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I am 18 years old or older.
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I can care for myself and am up and about more than 50% of my waking hours.
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I have at least one tumor that can be measured on a scan.
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I have a confirmed diagnosis of PVNS that cannot be surgically removed, has spread, or I refuse surgery.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I cannot undergo MRI scans due to health reasons.
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I have not taken drugs like nilotinib or imatinib for a giant cell tumor.
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I am currently on a strong medication that cannot be stopped or changed before starting the study drug.
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I have liver disease.
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I have a history of serious bleeding problems not related to cancer.
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I have not had major surgery in the last 28 days.
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I am not pregnant or breastfeeding.
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I am not on medication that affects heart rhythm or can't switch before the study.
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I have a stomach or intestine problem that affects how I absorb medicine.
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I do not have another cancer that needs treatment.
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I have a pancreatic disease.
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My heart does not function properly.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Percentage of Participants With Progression Free Survival
Secondary study objectives
Clinical Benefit Rate
Overall Tumor Response Rate (OR)

Side effects data

From 2019 Phase 3 trial • 846 Patients • NCT00471497
45%
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%
Fatigue
20%
Hypertension
20%
Hypophosphataemia
20%
Myalgia
20%
Pruritus
19%
Constipation
19%
Hyperbilirubinaemia
19%
Pain in extremity
18%
Influenza
18%
Pyrexia
17%
Abdominal pain
16%
Anaemia
16%
Oedema peripheral
16%
Aspartate aminotransferase increased
15%
Blood bilirubin increased
14%
Muscle spasms
14%
Hypercholesterolaemia
14%
Dry skin
14%
Lipase increased
14%
Musculoskeletal pain
13%
Dyspepsia
13%
Insomnia
12%
Dizziness
11%
Dyspnoea
11%
Neutropenia
10%
Sinusitis
10%
Asthenia
10%
Oropharyngeal pain
10%
Urinary tract infection
10%
Bone pain
10%
Hyperglycaemia
9%
Non-cardiac chest pain
8%
Leukopenia
8%
Amylase increased
8%
Weight increased
8%
Decreased appetite
8%
Dry eye
8%
Gastroenteritis
8%
Anxiety
7%
Haemorrhoids
7%
Bronchitis
7%
Palpitations
6%
Pharyngitis
6%
Gastrooesophageal reflux disease
6%
Blood alkaline phosphatase increased
6%
Conjunctivitis
6%
Folliculitis
6%
Hyperhidrosis
6%
Erythema
6%
Night sweats
6%
Depression
6%
Gastritis
5%
Flatulence
5%
Blood cholesterol increased
5%
Blood phosphorus decreased
5%
Influenza like illness
5%
Chills
5%
Haemoglobin decreased
5%
Procedural pain
5%
Hyperlipidaemia
5%
Abdominal distension
5%
Hyperuricaemia
5%
Vertigo
5%
Weight decreased
4%
Toothache
4%
Hypoaesthesia
4%
Blood creatinine increased
4%
Coronary artery disease
4%
Angina pectoris
4%
Neck pain
4%
Hypokalaemia
4%
Eczema
4%
Paraesthesia
3%
Face oedema
3%
Herpes zoster
2%
Pneumonia
2%
Transient ischaemic attack
2%
Conjunctival haemorrhage
2%
Myocardial infarction
2%
Acute myocardial infarction
2%
Eyelid oedema
2%
Peripheral arterial occlusive disease
1%
Peripheral artery stenosis
1%
Pilonidal cyst
1%
Periorbital oedema
1%
Inguinal hernia
1%
Neuropathy peripheral
1%
Cellulitis
1%
Azotaemia
1%
Death
1%
Cerebral haemorrhage
1%
Intestinal obstruction
1%
Migraine
1%
Angina unstable
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

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
~4370

Find a Location

Who is running the clinical trial?

Andrew J. Wagner, MD, PhDLead Sponsor
Brigham and Women's HospitalOTHER
1,669 Previous Clinical Trials
11,877,799 Total Patients Enrolled
Massachusetts General HospitalOTHER
3,026 Previous Clinical Trials
13,413,803 Total Patients Enrolled
NovartisIndustry Sponsor
1,639 Previous Clinical Trials
2,774,286 Total Patients Enrolled

Media Library

Nilotinib (Tyrosine Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT01207492 — Phase 2
Pigmented Villonodular Synovitis Research Study Groups: Nilotinib
Pigmented Villonodular Synovitis Clinical Trial 2023: Nilotinib Highlights & Side Effects. Trial Name: NCT01207492 — Phase 2
Nilotinib (Tyrosine Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01207492 — Phase 2
~1 spots leftby Dec 2025
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