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Janus Kinase (JAK) Inhibitor

Continued Itacitinib Treatment for Myelofibrosis

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 3 years

Awards & highlights

Study Summary

This trial is designed to provide itacitinib to people who have already been taking it and who may benefit from continued treatment. Eligible participants will receive the same dose and schedule of itacitinib as they received in the previous study. Treatment may be continued as long as the participant does not experience negative side effects, still derives benefit from the drug, and does not meet any other criteria for discontinuation.

Who is the study for?

This trial is for patients already taking itacitinib in other Incyte-sponsored studies, who are benefiting and tolerating the treatment well. They must understand and agree to study procedures, avoid pregnancy or fathering children, and not have any illness that could risk their safety or study compliance.Check my eligibility

What is being tested?

The trial provides ongoing access to itacitinib for participants from previous related studies. It's an open-label study where all involved know they're receiving itacitinib at doses and schedules set by earlier trials as long as benefits continue and side effects remain manageable.See study design

What are the potential side effects?

While specific side effects aren't listed here, continued use of itacitinib may include previously encountered adverse reactions such as immune system effects, liver issues, blood count changes or infections. Tolerance is assessed based on past experiences in the parent protocol.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 years

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

Treatment Details

Study Objectives

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

Primary outcome measures

Treatment Emergent Adverse Events (TEAE's)

Side effects data

From 2022 Phase 1 & 2 trial • 33 Patients • NCT02760485

50%

Fatigue

33%

Asthenia

33%

Anaemia

33%

Nausea

33%

Constipation

33%

Cough

33%

Diarrhoea

33%

Mental status changes

17%

Cheilitis

17%

Abdominal pain upper

17%

Wound infection pseudomonas

17%

Abdominal discomfort

17%

Dyspepsia

17%

Skin infection

17%

Hypertension

17%

Dizziness

17%

Rash

17%

Headache

17%

Pollakiuria

17%

Tremor

17%

Upper respiratory tract infection

17%

Muscle tightness

17%

Pain in extremity

17%

Peripheral sensory neuropathy

17%

Thrombocytopenia

17%

Vision blurred

17%

Pneumonia

17%

Pneumonia aspiration

17%

Tinnitus

17%

Blood cholesterol increased

17%

Chronic kidney disease

17%

Confusional state

17%

Decreased appetite

17%

Dyspnoea

17%

Eye irritation

17%

Haematoma

17%

Tongue eruption

17%

Injection site bruising

17%

Joint swelling

17%

Lymphocyte count decreased

17%

Palpitations

17%

Disorientation

17%

Epistaxis

17%

Oropharyngeal pain

17%

Impetigo

100%

80%

60%

40%

20%

Study treatment Arm

Phase 1; Cohort 1: Itacitinib 300 mg QD + Ibrutinib 560 mg QD

Phases 1 and 2: Itacitinib 400 mg QD + Ibrutinib 560 mg QD

Total

Trial Design

1Treatment groups

Experimental Treatment

Group I: itacitinibExperimental Treatment1 Intervention

Participants will receive treatment with itacitinib as per the treatment dose and schedule they received in the study in which they were originally enrolled. Participants who are receiving ruxolitinib under parent protocol INCB39110-209 may continue to receive it as described in that protocol.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

itacitinib

2016

Completed Phase 2

~340

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Incyte CorporationLead Sponsor

364 Previous Clinical Trials

55,147 Total Patients Enrolled

Lance Leopold, MDStudy DirectorIncyte Corporation

14 Previous Clinical Trials

1,457 Total Patients Enrolled

Media Library

itacitinib (Janus Kinase (JAK) Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04640025 — Phase 2

Frequently Asked Questions

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

Does this research endeavor introduce a novel approach to the field?

"The pharmaceutical Incyte Corporation has been researching itacitinib since 2013, conducting 23 trials across 20 countries and 76 cities. To date, 12 of these studies have concluded, with the earliest trial containing 121 patients who were able to successfully complete Phase 1 drug approval."

Answered by AI

How many healthcare institutions are participating in this research endeavor?

"City of Hope National Medical Center in Duarte, Temple University in Cleveland and the Cleveland Clinic Vancouver are amongst 8 sites running this trial. There is also a selection of other clinical centres hosting this study."

Answered by AI

Has the FDA given its approval to itacitinib?

"There is some evidence for itacitinib's safety, yet no proof of efficacy. For this reason, our team at Power gave a rating of 2 to its safety profile."

Answered by AI

Is the enrollment of participants open in this investigation?

"Affirmative. Clinicaltrials.gov confirms that this trial is actively searching for participants, which began on March 10th 2021 and was amended most recently in November 15th 2022. This medical study requires the enrollment of 100 individuals across 8 research sites."

Answered by AI

Has itacitinib been tested in prior experiments?

"Currently, 23 clinical trials are being conducted on itacitinib. One of these is in the final phase 3 stage. The majority of studies take place at research sites within Philadelphia, Pennsylvania, but there are a total of 397 locations evaluating this medication's efficacy and safety."

Answered by AI

How many participants are participating in this research endeavor?

"Affirmative, the information on clinicaltrials.gov verifies that this experiment is in need of volunteers - it was initially posted on March 10th 2021 and updated most recently on November 15 2022. 100 participants are expected to join at 8 different medical centres."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Rollover Study to Provide Continued Treatment for Participants Previously Enrolled in Studies of Itacitinib

2021. "A Rollover Study to Provide Continued Treatment for Participants Previously Enrolled in Studies of Itacitinib". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04640025.

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