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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
368 Previous Clinical Trials
55,455 Total Patients Enrolled
~1 spots leftby Jun 2025
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