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Ruxolitinib Continuation for Cancer

Q: How is Ruxolitinib used to help patients?

<p>Ruxolitinib is often used to treat <a href="https://www.withpower.com/clinical-trials/polycythemia-vera">polycythemia vera</a>. However, it can also be an effective medication for patients that are resistant or intolerant of hydroxyurea, have metastatic colorectal carcinoma, and/or primary <a href="https://www.withpower.com/clinical-trials/myelofibrosis">myelofibrosis</a>.</p>

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

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

Study 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.Check my eligibility

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.See study design

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.

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

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

Primary outcome measures

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

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

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

Capecitabine

2013

Completed Phase 3

~3420

Regorafenib

2014

Completed Phase 2

~1580

Ruxolitinib

2018

Completed Phase 3

~1140

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Incyte CorporationLead Sponsor

364 Previous Clinical Trials

55,155 Total Patients Enrolled

Fitzroy Dawkins, MDStudy DirectorIncyte Corporation

6 Previous Clinical Trials

558 Total Patients Enrolled

Peter Langmuir, MDStudy DirectorIncyte Corporation

10 Previous Clinical Trials

1,019 Total Patients Enrolled

Media Library

Ruxolitinib Clinical Trial Eligibility Overview. Trial Name: NCT02955940 — Phase 2

Pancreatic Cancer Research Study Groups: Ruxolitinib, Ruxolitinib plus background cancer therapy, Background cancer therapy alone

Pancreatic Cancer Clinical Trial 2023: Ruxolitinib Highlights & Side Effects. Trial Name: NCT02955940 — Phase 2

Ruxolitinib 2023 Treatment Timeline for Medical Study. Trial Name: NCT02955940 — Phase 2

Frequently Asked Questions

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

How many people can join this experiment at most?

"This study is not recruiting at this time. The trial was originally posted on 11/30/2016 and was last updated on 7/6/2022. There are presently 2685 trials actively searching for participants with breast cancer and 508 studies for Ruxolitinib actively looking for participants."

Answered by AI

How is Ruxolitinib used to help patients?

"Ruxolitinib is often used to treat polycythemia vera. However, it can also be an effective medication for patients that are resistant or intolerant of hydroxyurea, have metastatic colorectal carcinoma, and/or primary myelofibrosis."

Answered by AI

Does Ruxolitinib have a good safety profile?

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

Answered by AI

Ruxolitinib has been investigated before, correct?

"Ruxolitinib was first researched in 2002 at National Institutes of Health Clinical Center. As of now, 725 clinical trials have been completed with 508 live studies. A large portion of these ongoing trials are taking place in Louisville, Kentucky."

Answered by AI

Are patients still being recruited for this experiment?

"The clinicaltrials.gov database reveals that this trial is not currently recruiting patients. The listing was created on 30/11/2016 and updated on 06/07/2022. Although this study is no longer looking for participants, there are 3193 other trials with open recruitment at present."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

An Open-Label Study to Enable Continued Treatment Access for Subjects Previously Enrolled in Studies of Ruxolitinib

2016. "An Open-Label Study to Enable Continued Treatment Access for Subjects Previously Enrolled in Studies of Ruxolitinib". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02955940.

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