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Janus Kinase (JAK) Inhibitor

itacitinib for Thrombocythemia

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 13 months
Awards & highlights

Study Summary

This trial has two parts. In the first, participants will be given different doses of the study drug to find the best dose (RP2D). In the second part, everyone will get the RP2D.

Eligible Conditions
  • Thrombocythemia
  • Polycythemia Vera
  • Myelofibrosis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~13 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 13 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
Part 1 : Treatment Emergent Adverse Events (TEAE'S)
Part 2 : Spleen Volume Reduction
Part 2 : Spleen Volume Reduction by MRI/CT Scan
Secondary outcome measures
Part 2 : Improvement in Patient Global Impression of Change (PGIC)
Part 2 : Improvement in Total Symptom Score (TSS)
Part 2 : Improvement in quality of life.
+1 more

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%
0%
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

2Treatment groups
Experimental Treatment
Group I: Part 2 : Dose Expansion of itacitinibExperimental Treatment1 Intervention
Participants will be dosed at the recommended Phase 2 dose (RP2D) identified in Part 1.
Group II: Part 1 : Dose Escalation of itacitinibExperimental Treatment1 Intervention
Participants will be dosed at different dose levels with a maximum of up to 9 participants per dose level.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
itacitinib
2016
Completed Phase 2
~340

Find a Location

Who is running the clinical trial?

Incyte CorporationLead Sponsor
364 Previous Clinical Trials
55,161 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 primary aim of this research project?

"The Incyte Corporation, sponsor of this clinical trial, has specified that the primary objective—to be measured over a 24-week period—is Part 2: Spleen Volume Reduction by MRI/CT Scan. Additionally, this trial will assess secondary outcomes including Part 2: Treatment Emergent Adverse Events (TEAEs), defined as any adverse event either reported for the first time or worsening of a pre-existing event after first dose of study treatment up to 30 days after last dose of study treatment; Part 2: Improvement in Patient Global Impression of Change (PGIC), defined as percentage of participants who are categorized as improved"

Answered by AI

Does itacitinib have a history of being tested in other medical trials?

"There are a total of 23 clinical trials evaluating itacitinib. 1 study has reached Phase 3. The concentration of research for this medication is in Houston, Texas; however, there are 396 locations conducting these medical studies."

Answered by AI

How many people are chosen to participate in this experiment?

"This study is no longer enrolling patients. According to the posting date and most recent edit, this trial was only active for about a year. There are plenty of other ongoing trials that may be of interest; 137 studies are recruiting thrombocythemia patients and 23 trials are looking for participants to test itacitinib."

Answered by AI

What does the research say about itacitinib's safety for human beings?

"While there is some data supporting itacitinib's safety, as this is only a Phase 2 trial, the Power team could only rate its safety at a 2."

Answered by AI

Can people with the relevant medical condition join this trial at this time?

"No, this particular clinical trial is not currently recruiting patients. Although the study was first posted on July 12th, 2021, it stopped actively searching for participants as of August 25th, 2022. There are however 160 other trials that patients may be interested in that are actively recruiting right now."

Answered by AI

Is this a novel clinical trial?

"Incyte Corporation first began studying itacitinib in 2013 through a Phase 1 trial with 121 participants. After the success of the initial study, 23 more active trials have been made for itacitinib across 76 cities and 20 countries."

Answered by AI

How many research facilities are conducting this experiment?

"There are 9 clinical trial sites where patients can receive this treatment, including Renovatio Clinical Consultants, LLC in Kansas City, Missouri and Midamerica Cancer Care in Memphis, Tennessee."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
To Assess the Safety, Tolerability and Efficacy of Itacitinib Immediate Release Tablets in Participants With Primary or Secondary Myelofibrosis Who Have Received Prior Ruxolitinib and/or Fedratinib Monotherapy (LIMBER-213)
2021. "To Assess the Safety, Tolerability and Efficacy of Itacitinib Immediate Release Tablets in Participants With Primary or Secondary Myelofibrosis Who Have Received Prior Ruxolitinib and/or Fedratinib Monotherapy (LIMBER-213)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04629508.
~1 spots leftby Apr 2025
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