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Crizotinib for Uveal Melanoma
Phase 2
Waitlist Available
Led By Shaheer A Khan, DO
Research Sponsored by Columbia University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 36 months
Awards & highlights
Study Summary
This trial will look at whether the addition of crizotinib to standard care can help to prevent uveal melanoma from coming back in patients who are at high risk for recurrence.
Eligible Conditions
- Uveal Melanoma
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 36 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 36 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Relapse Free Survival (RFS) Rate at 32 Months
Secondary outcome measures
Disease-Specific Survival (DSS) Time
Number of Participants With Treatment Discontinuation Due to Toxicity
Overall Survival (OS)
Side effects data
From 2020 Phase 3 trial • 207 Patients • NCT0163900155%
White blood cell count decreased
50%
Nausea
49%
Anaemia
46%
Vomiting
45%
Alanine aminotransferase increased
37%
Neutropenia
35%
Aspartate aminotransferase increased
33%
Neutrophil count decreased
33%
Decreased appetite
27%
Constipation
27%
Platelet count decreased
24%
Cough
21%
Haemoglobin decreased
20%
Leukopenia
17%
Chest pain
17%
Fatigue
16%
Blood albumin decreased
16%
Hyponatraemia
15%
Pyrexia
13%
Back pain
11%
Dizziness
11%
Dyspnoea
11%
Alopecia
10%
Thrombocytopenia
10%
Asthenia
9%
Diarrhoea
9%
Headache
9%
Insomnia
9%
Red blood cell count decreased
8%
Phlebitis
8%
Visual impairment
8%
Upper respiratory tract infection
8%
Nasopharyngitis
8%
Hypoalbuminaemia
8%
Haemoptysis
8%
Pruritus
7%
Rash
7%
Hypokalaemia
6%
Blood bilirubin increased
6%
Lymphocyte count decreased
6%
Pain in extremity
6%
Abdominal distension
6%
Pain
6%
Productive cough
5%
Oedema peripheral
5%
Musculoskeletal pain
4%
Arthralgia
4%
Vision blurred
4%
Chest discomfort
4%
Blood alkaline phosphatase increased
4%
Gamma-glutamyltransferase increased
4%
Paraesthesia
4%
Hypocalcaemia
3%
Abdominal pain
3%
Protein total decreased
2%
Abdominal pain upper
2%
Hypoaesthesia
1%
Pleural effusion
1%
Disease progression
1%
Death
1%
Blood creatinine increased
1%
Pneumonia
1%
Oedema
1%
Blood lactate dehydrogenase increased
1%
Hypoproteinaemia
1%
Hypertension
1%
Pericardial effusion
1%
Syncope
1%
Transaminases increased
1%
Cerebral infarction
100%
80%
60%
40%
20%
0%
Study treatment Arm
Chemotherapy
Crizotinib
Trial Design
1Treatment groups
Experimental Treatment
Group I: CrizotinibExperimental Treatment1 Intervention
Subjects will receive 48 weeks (12 four-week cycles) of crizotinib 250 mg PO twice a day (BID). Subjects will be evaluated by routine bloodwork and physical exam every 4 weeks while they are receiving crizotinib and during follow up period.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Crizotinib
2014
Completed Phase 3
~2370
Find a Location
Who is running the clinical trial?
Columbia UniversityLead Sponsor
1,433 Previous Clinical Trials
2,460,981 Total Patients Enrolled
PfizerIndustry Sponsor
4,570 Previous Clinical Trials
10,910,444 Total Patients Enrolled
Shaheer A Khan, DOPrincipal InvestigatorAssistant Professor of Medicine at the Columbia University Medical Center
Frequently Asked Questions
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