Actively Recruiting
A Study to Evaluate INCA033989 Administered as a Monotherapy or in Combination With Ruxolitinib in Participants With Myeloproliferative Neoplasms
Led by Incyte Corporation · Updated on 2026-03-24
225
Participants Needed
29
Research Sites
231 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study is being conducted to evaluate the safety, tolerability, and dose-limiting toxicity (DLT) and determine the maximum tolerated dose (MTD) and/or recommended dose(s) for expansion (RDE) of INCA033989 administered as a monotherapy or in combination with ruxolitinib in participants with myeloproliferative neoplasms.
CONDITIONS
Official Title
A Study to Evaluate INCA033989 Administered as a Monotherapy or in Combination With Ruxolitinib in Participants With Myeloproliferative Neoplasms
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Life expectancy greater than 6 months
- Willingness to undergo pretreatment and regular on-study bone marrow biopsies and aspirates as appropriate
- Existing documentation from a qualified local laboratory of CALR exon-9 mutation
- Participants with myelofibrosis (MF) and essential thrombocythemia (ET) as defined in the protocol
You will not qualify if you...
- Presence of any hematological malignancy other than ET, primary myelofibrosis (PMF), or post-ET MF
- Active invasive malignancy within the previous 2 years
- Active hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV) infection
- History of clinically significant or uncontrolled cardiac disease
- Prior or planned allogenic or autologous stem-cell transplantation
- Laboratory values outside protocol-defined ranges
- Treatment with G-CSF, GM-CSF, or TPO-R agonists within 4 weeks before first dose
- Prior major bleeding or thrombosis within 3 months before enrollment
- Prior chemotherapy, immunomodulatory, immunosuppressive, biological, endocrine, targeted therapy, antibody, or hypomethylating agent within 5 half-lives or 28 days before first dose
- For transplant graft biopsies only: Treatment with potent/strong CYP 3A4/5 inhibitors or inducers within 14 days or 5 half-lives before first dose, or expected during study
- Other protocol-defined inclusion/exclusion criteria may apply
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 29 locations
1
Royal Brisbane and Women'S Hospital
Herston, Queensland, Australia, 04029
Actively Recruiting
2
Royal Adelaide Hospital
Adelaide, South Australia, Australia, 05000
Actively Recruiting
3
Peter Maccallum Cancer Centre
Melbourne, Victoria, Australia, 03000
Actively Recruiting
4
The Alfred Hospital
Melbourne, Victoria, Australia, 03004
Actively Recruiting
5
Princess Margaret Cancer Center
Toronto, Ontario, Canada, M5G 2M9
Actively Recruiting
6
Hopital Maisonneuve-Rosemont, Montreal, Qc
Montreal, Quebec, Canada, H1T 2M4
Actively Recruiting
7
Odense University Hospital
Odense C, Denmark, 05000
Withdrawn
8
Sjaellands Universitetshospital
Roskilde, Denmark, 04000
Actively Recruiting
9
Vejle Hospital
Vejle, Denmark, 07100
Actively Recruiting
10
Institut Bergonie
Bordeaux, France, 33076
Actively Recruiting
11
Chu Nimes
Nîmes, France, 30029
Actively Recruiting
12
Hospital Saint Louis
Paris, France, 75010
Actively Recruiting
13
Institut Gustave Roussy
Villejuif, France, 94805
Actively Recruiting
14
University Medical Center Rwth Aachen
Aachen, Germany, 52074
Actively Recruiting
15
Universitatsklinikum Halle (Saale)
Halle, Germany, 06120
Actively Recruiting
16
Universitätsklinikum Ulm
Ulm, Germany, 89081
Actively Recruiting
17
Aou Policlinico S. Orsola-Malpighi
Bologna, Italy, 40138
Actively Recruiting
18
Azienda Ospedaliero-Universitaria Careggi (Aouc)
Florence, Italy, 50134
Actively Recruiting
19
Fondazione Irccs Ca Granda Ospedale Maggiore
Milan, Italy, 20122
Actively Recruiting
20
National Cancer Center Hospital East
Chiba-ken, Japan, 277-0882
Actively Recruiting
21
Kagoshima University Hospital
Kagoshima, Japan, 890-8520
Actively Recruiting
22
Osaka Metropolitan University Hospital
Osaka, Japan, 545-8586
Actively Recruiting
23
Nippon Medical School Hospital
Tokyo, Japan, 113-8603
Actively Recruiting
24
Mie University Hospital
Tsu, Japan, 514-0001
Actively Recruiting
25
Hospital Universitario 12 de Octubre
Madrid, Spain, 28041
Actively Recruiting
26
Hospital Universitari I Politecnic La Fe
Valencia, Spain, 46026
Actively Recruiting
27
Guys and St Thomas Nhs Foundation Trust
London, United Kingdom, SE1 9RT
Actively Recruiting
28
The Christie Nhs Foundation Trust Uk
Manchester, United Kingdom, M20 4BV
Actively Recruiting
29
University of Oxford
Oxford, United Kingdom, OX3 7LE
Actively Recruiting
Research Team
I
Incyte Corporation Call Center (US)
CONTACT
I
Incyte Corporation Call Center (ex-US)
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
7
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