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JAK1/2 Inhibitor
Ruxolitinib for Squamous Cell Carcinoma
Phase 2
Waitlist Available
Led By Alexander Wei, MD
Research Sponsored by Columbia University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
History of solid-organ transplant requiring immunosuppression
Karnofsky Performance Status Scale (KPS) ≥60%, Eastern Cooperative Oncology Group (ECOG) ≤2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 36 months
Awards & highlights
Study Summary
This trial is testing a new cancer treatment and whether it is safe for people who have had solid organ transplants.
Who is the study for?
This trial is for adults over 18 with advanced skin cancer (cSCC) after a solid organ transplant. They must have measurable disease, be in fair health (KPS ≥60%, ECOG ≤2), and have recovered from previous treatments. A biopsy may be required, they can't be pregnant, must take oral meds well, haven't used JAK inhibitors before, and their organs must work properly.Check my eligibility
What is being tested?
The study tests Ruxolitinib's effectiveness on cSCC in transplant recipients. Initially, patients get 15mg twice daily; if side effects are manageable, the dose continues or reduces to 10mg based on early results. It's an open-label Phase II trial using Simon two-stage design to adjust dosing.See study design
What are the potential side effects?
Potential side effects of Ruxolitinib include blood disorders that could affect your immune system and increase infection risk; liver issues; headaches; dizziness; and possible increased cholesterol levels. Side effects depend on individual reactions and dosage tolerance.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have had an organ transplant and am on immunosuppressants.
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I can care for myself and perform daily activities.
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My blood counts meet the required levels for treatment.
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I am 18 years old or older.
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My skin cancer is confirmed to be advanced and has spread.
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I have never been treated with JAK inhibitor therapy.
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
Overall Response Rate (ORR)
Secondary outcome measures
Overall Survival (OS)
Progression-Free Survival (PFS)
Side effects data
From 2020 Phase 3 trial • 149 Patients • NCT0203803633%
Anaemia
19%
Hypertension
17%
Nasopharyngitis
16%
Weight increased
14%
Herpes zoster
14%
Constipation
14%
Abdominal pain
14%
Headache
12%
Pruritus
12%
Back pain
12%
Epistaxis
12%
Pyrexia
12%
Dizziness
10%
Asthenia
10%
Fatigue
10%
Cough
10%
Oedema peripheral
10%
Arthralgia
9%
Thrombocytosis
9%
Upper respiratory tract infection
9%
Hypercholesterolaemia
7%
Dyslipidaemia
7%
Pain in extremity
7%
Haematoma
7%
Abdominal discomfort
7%
Diarrhoea
7%
Dyspepsia
7%
Vomiting
7%
Blood lactate dehydrogenase increased
7%
Memory impairment
7%
Dyspnoea
5%
Tinnitus
5%
Osteoarthritis
5%
Leukocytosis
5%
Thrombocytopenia
5%
Flatulence
5%
Nausea
5%
Sinusitis
5%
Basal cell carcinoma
5%
Neuropathy peripheral
5%
Hyperuricaemia
3%
Cystitis
3%
Bronchitis
3%
Blood creatine phosphokinase increased
3%
Paraesthesia
3%
Skin ulcer
3%
Abdominal pain upper
3%
Pulmonary embolism
3%
Pneumonia
3%
Influenza
3%
Myalgia
3%
Urinary tract infection
3%
Depression
2%
Vertigo
2%
Localised infection
2%
Urethral stenosis
2%
Night sweats
2%
Acute pulmonary oedema
2%
Intervertebral disc protrusion
2%
Peripheral artery thrombosis
2%
Ureterolithiasis
2%
Pericardial effusion
2%
Acute myocardial infarction
2%
Syncope
2%
Gastrooesophageal reflux disease
2%
General physical health deterioration
2%
Atrial fibrillation
2%
Cardiac disorder
2%
Mitral valve incompetence
2%
Vertigo positional
2%
Retinal artery occlusion
2%
Visual acuity reduced
2%
Gastrointestinal haemorrhage
2%
Oesophageal varices haemorrhage
2%
Lower respiratory tract infection
2%
Pyelonephritis
2%
Respiratory tract infection
2%
Sepsis
2%
Tendon rupture
2%
Ulna fracture
2%
Weight decreased
2%
Decreased appetite
2%
Hyponatraemia
2%
Blast cell crisis
2%
Bone marrow tumour cell infiltration
2%
Lung adenocarcinoma
2%
Metastases to spine
2%
Myelofibrosis
2%
Prostatic adenoma
2%
Squamous cell carcinoma of skin
2%
Nephrolithiasis
2%
Gamma-glutamyltransferase increased
2%
Haematocrit increased
2%
Musculoskeletal pain
2%
Ischaemic stroke
2%
Diabetes mellitus
100%
80%
60%
40%
20%
0%
Study treatment Arm
All Crossover Patients
Best Available Therapy
Ruxolitinib
Trial Design
1Treatment groups
Experimental Treatment
Group I: RuxolitinibExperimental Treatment1 Intervention
In a safety lead-in of 6 patients, subjects will receive 15mg of ruxolitinib twice daily (BID). After 4 weeks, if dose-limiting toxicities (DLT) are observed in 1 or fewer patients, the study will enter stage 1 of the Simon two-stage design where all subsequent patients will receive a starting dose of ruxolitinib 15mg BID.
Subjects will have regularly scheduled study visits at the clinical site on Day 1 and Day 15 (± 3 days) of the first 2 cycles, then on Day 1 (± 3 days) of every subsequent cycle (starting cycle 3), where safety assessments, including laboratory assessments, vital signs, and physical examinations will be performed.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ruxolitinib
2018
Completed Phase 3
~1140
Find a Location
Who is running the clinical trial?
Columbia UniversityLead Sponsor
1,439 Previous Clinical Trials
2,447,659 Total Patients Enrolled
Incyte CorporationIndustry Sponsor
368 Previous Clinical Trials
55,458 Total Patients Enrolled
Alexander Wei, MDPrincipal InvestigatorAssociate Professor of Medicine at the Columbia University Medical Center
1 Previous Clinical Trials
27 Total Patients Enrolled
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