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Ruxolitinib Continuation for Cancer

Phase 2

Waitlist Available

Research Sponsored by Incyte Corporation

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Must not have

Able to access ruxolitinib and/or background cancer therapy outside of the clinical study

Timeline

Screening 3 weeks

Treatment Varies

Follow Up maximum duration of every 2 months (maximum duration of 1 month for subjects receiving regorafenib) from enrollment through 30-37 days after end of treatment up to 24 months.

Awards & highlights

No Placebo-Only Group

Summary

This trial is for subjects who have completed an Incyte-sponsored study of ruxolitinib and will continue receiving the drug, ruxolitinib plus cancer therapy, or just cancer therapy. The purpose is to monitor safety and adverse events.

Who is the study for?

This trial is for patients already in an Incyte-sponsored ruxolitinib study that's ended or stopped. They should have stable disease, be tolerating and benefiting from their current treatment (ruxolitinib alone, with other cancer drugs, or just the cancer drugs), and must have followed the original study rules.

What is being tested?

The trial provides ongoing access to ruxolitinib for those who were part of previous studies. It examines continued use of ruxolitinib by itself, combined with standard cancer treatments like Capecitabine and Regorafenib, or these treatments on their own.

What are the potential side effects?

Possible side effects include blood count changes, infections risk increase, liver function alterations, headaches, dizziness and fatigue. The exact side effects can vary based on whether ruxolitinib is taken alone or with other cancer therapies.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I can get ruxolitinib or other cancer treatments not provided by the study.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ maximum duration of every 2 months (maximum duration of 1 month for subjects receiving regorafenib) from enrollment through 30-37 days after end of treatment up to 24 months.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~maximum duration of every 2 months (maximum duration of 1 month for subjects receiving regorafenib) from enrollment through 30-37 days after end of treatment up to 24 months.

This trial's timeline: 3 weeks for screening, Varies for treatment, and maximum duration of every 2 months (maximum duration of 1 month for subjects receiving regorafenib) from enrollment through 30-37 days after end of treatment up to 24 months. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Frequency and types of adverse events and serious adverse events

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

Haematoma

Dyslipidaemia

Pain in extremity

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

Paraesthesia

Bronchitis

Cystitis

Blood creatine phosphokinase increased

Skin ulcer

Abdominal pain upper

Pulmonary embolism

Pneumonia

Influenza

Myalgia

Urinary tract infection

Depression

Acute pulmonary oedema

Peripheral artery thrombosis

Vertigo

Night sweats

Intervertebral disc protrusion

Urethral stenosis

Ureterolithiasis

Localised infection

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Group I: Ruxolitinib plus background cancer therapyExperimental Treatment3 Interventions

Study treatment for participants should be the same as the dosage from the parent study at the time the roll over protocol is initiated. Dose modifications are permitted.

Group II: RuxolitinibExperimental Treatment1 Intervention

Study treatment for participants should be the same as the dosage from the parent study at the time the roll over protocol is initiated. Dose modifications are permitted.

Group III: Background cancer therapy aloneExperimental Treatment2 Interventions

Capecitabine and Regorafenib at the same dose provided in the parent study at the time of the rollover.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Regorafenib

2014

Completed Phase 2

~1630

Ruxolitinib

2018