← Back to Search

Janus Kinase (JAK) Inhibitor

Ruxolitinib for Head and Neck Squamous Cell Carcinoma

Phase 2

Waitlist Available

Led By William Ryan, MD

Research Sponsored by University of California, San Francisco

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 12 weeks

Awards & highlights

Study Summary

This trial will test if a drug called ruxolitinib is safe and effective in treating people with a certain type of cancer of the head and neck who are scheduled for surgery.

Eligible Conditions

Head and Neck Squamous Cell Carcinoma (HNSCC)

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 12 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 12 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 12 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Median change in Tumor Size

Secondary outcome measures

Change in Ki-67 proliferative index value

Identification of biomarkers

Median length of hospital stay

+2 more

Side effects data

From 2020 Phase 3 trial • 149 Patients • NCT02038036

33%

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

Thrombocytosis

Upper respiratory tract infection

Hypercholesterolaemia

Dyslipidaemia

Pain in extremity

Haematoma

Abdominal discomfort

Diarrhoea

Dyspepsia

Vomiting

Blood lactate dehydrogenase increased

Memory impairment

Dyspnoea

Tinnitus

Osteoarthritis

Leukocytosis

Thrombocytopenia

Flatulence

Nausea

Sinusitis

Basal cell carcinoma

Neuropathy peripheral

Hyperuricaemia

Blood creatine phosphokinase increased

Cystitis

Bronchitis

Paraesthesia

Skin ulcer

Abdominal pain upper

Pulmonary embolism

Pneumonia

Influenza

Myalgia

Urinary tract infection

Depression

Localised infection

Urethral stenosis

Night sweats

Acute pulmonary oedema

Intervertebral disc protrusion

Vertigo

Peripheral artery thrombosis

Ureterolithiasis

Pericardial effusion

Acute myocardial infarction

Syncope

Gastrooesophageal reflux disease

General physical health deterioration

Atrial fibrillation

Cardiac disorder

Mitral valve incompetence

Vertigo positional

Retinal artery occlusion

Visual acuity reduced

Gastrointestinal haemorrhage

Oesophageal varices haemorrhage

Lower respiratory tract infection

Pyelonephritis

Respiratory tract infection

Sepsis

Tendon rupture

Ulna fracture

Weight decreased

Decreased appetite

Hyponatraemia

Blast cell crisis

Bone marrow tumour cell infiltration

Lung adenocarcinoma

Metastases to spine

Myelofibrosis

Prostatic adenoma

Squamous cell carcinoma of skin

Nephrolithiasis

Gamma-glutamyltransferase increased

Haematocrit increased

Musculoskeletal pain

Ischaemic stroke

Diabetes mellitus

100%

80%

60%

40%

20%

Study treatment Arm

All Crossover Patients

Best Available Therapy

Ruxolitinib

Trial Design

1Treatment groups

Experimental Treatment

Group I: Neoadjuvant RuxolitinibExperimental Treatment1 Intervention

Participants will take 15 mg or 20 mg of ruxolitinib by mouth twice daily for up to 4 weeks during the pre-operative window for 14-21 days, or up to 28 days for delays in planned surgery. Dose will be assigned based on participant platelet count at baseline. The last dose will be taken the morning of planned surgery. Ruxolitinib will be dispensed in 5 mg tablets. Participants will either take three tables (15 mg) in the morning and evening, or four tablets in the morning and evening (20 mg). Participants will be asked to fill out a drug diary indicating when doses of study drug are taken and any side effects they experience.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Ruxolitinib

2018

Completed Phase 3

~1140

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of California, San FranciscoLead Sponsor

2,505 Previous Clinical Trials

15,237,539 Total Patients Enrolled

Incyte CorporationIndustry Sponsor

364 Previous Clinical Trials

55,149 Total Patients Enrolled

William Ryan, MDPrincipal InvestigatorUniversity of California, San Francisco

1 Previous Clinical Trials

53 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the Ruxolitinib approval status by the FDA?

"While there is some data supporting the safety of Ruxolitinib, it did not receive a higher score because Phase 2 trials lack evidence of efficacy."

Answered by AI

Can patients currently enroll in this trial?

"Yes, the trial is recruiting patients as of September 22nd, 2022. This is according to information on clinicaltrials.gov which also states that the study was originally posted on June 8th, 2018. 45 individuals are needed for the research project and they will be recruited from 2 sites."

Answered by AI

How many people will be participating in this experiment?

"That is correct, the online information specifies that the study is actively enrolling patients. The listing was first put up on 6/8/2018 and edited as recently as 9/22/2022. 45 individuals are needed to participate at 2 different hospitals or clinics."

Answered by AI

Are there comparable treatments to Ruxolitinib?

"Ruxolitinib was first studied in 2002 at National Institutes of Health Clinical Center. 92 clinical trials have completed since the medication's inception with 99 more currently active and ongoing. A large portion of these are located in San Francisco, California."

Answered by AI

What are some of the more common reasons that patients are given Ruxolitinib?

"Ruxolitinib is a medication used to treat polycythemia vera, but it can also help patients who are resistant or intolerant of hydroxyurea and have primary myelofibrosis."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Ruxolitinib in Operable Head and Neck Cancer

2018. "Ruxolitinib in Operable Head and Neck Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03153982.