MPN (Myeloproliferative Neoplasms)Phase 2NCT01633372
An Open Label Study of Itacitinib Administered Orally in Patients With Myelofibrosis
A Phase 2 study testing itacitinib in people with MPN (Myeloproliferative Neoplasms), run by Incyte Corporation at 22 sites in 3 countries.
Trial summary
This is a study of itacitinib (INCB039110) in patients with myelofibrosis. This study will evaluate safety and efficacy parameters of itacitinib (INCB039110). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- MPN (Myeloproliferative Neoplasms)
- What is being tested?
- itacitinib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 87 participants
- Where
- 22 sitesin 3 countries
- Study dates
- 16 Jul 2012to 29 Jun 2021
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Must be diagnosed with PMF, PPV-MF or PET-MF as confirmed by bone marrow biopsy.
- Must score at least 1 point on the Dynamic International Prognostic Scoring System (DIPSS) for prognostic risk factors and have peripheral blast count <10% at both Screening and Baseline hematology assessments.
- Subjects must discontinue all drugs used to treat underlying MF disease no later than Day -14.
- Subjects must have hemoglobin value >/= 8.0g/dL and be willing to receive blood transfusions, have a platelet count >/=50x10^9/L and absolute neutrophil count (ANC) >/= 1x10^9/L.
- Subjects must have palpable spleen or history of splenectomy
- Active symptoms at the screening visit
Who cannot join
- Women who are pregnant or breastfeeding, and men and women who cannot comply with requirements to avoid fathering a child or becoming pregnant, respectively.
- Subjects with impaired liver function, end stage renal disease on dialysis or clinically significant concurrent infections requiring therapy.
- Subjects with unstable cardiac function or invasive malignancies over the previous 2 years except treated basal or squamous carcinomas of the skin, completely resected intraepithelial carcinoma of the cervix and completely resected papillary thyroid and follicular thyroid cancers.
Trial locations and contacts
22 sites in 3 countries.
22 sites in 3 countries
United States14 sites
University of Michigan Cancer Center
Ann Arbor, Michigan
Emory University
Atlanta, Georgia
St Agnes Hospital
Baltimore, Maryland
Birmingham Hematology Oncology Associates, LLC
Birmingham, Alabama
South Carolina Oncology & Associates
Columbia, South Carolina
MD Anderson Cancer Center
Houston, Texas
UCLA Hematology & Oncology
Los Angeles, California
Boston Baskin Cancer Foundation, Inc.
Memphis, Tennessee
Tennessee Oncology
Nashville, Tennessee
Mount Sinai School of Medicine
New York, New York
University of Pennsylvania Health System
Philadelphia, Pennsylvania
Western Pennsylvania Hospital
Pittsburgh, Pennsylvania
Oregon Health & Science University
Portland, Oregon
Mayo Clinic, Arizona
Scottsdale, Arizona
Australia4 sites
Box Hill Hospital
Box Hill, Victoria
St Vincent's Hospital
Darlinghurst, New South Wales
Frankston Hospital
Frankston, Victoria
St. George Hospital
Kogarah, New South Wales
Canada4 sites
Cross Cancer Institute
Edmonton, Alberta
St. Mary's Hospital
Montreal, Quebec
Princess Margaret Hospital
Toronto, Ontario
St. Paul's Hospital
Vancouver, British Columbia
About this study
Official title: An Open-Label, Multiple Simon 2-Stage Study of Itacitinib Administered Orally to Subjects With Primary Myelofibrosis (PMF), Post Polycythemia Vera Myelofibrosis (PPV-MF) or Post Essential Thrombocythemia Myelofibrosis (PET-MF)
This is a study of itacitinib (INCB039110) in patients with myelofibrosis. This study will evaluate safety and efficacy parameters of itacitinib (INCB039110).
- Conditions
- MPN (Myeloproliferative Neoplasms)
- Being tested
- itacitinib
- Keywords
- Primary Myelofibrosis, PMF, Post Polycythemia Vera Fibrosis, PPV-MF, Post Essential Thrombocythemia Myelofibrosis, PET-MF
- Medical subject headings
- Myeloproliferative Disorders, Primary Myelofibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
itacitinibDrug
Also called INCB039110
| Study group | Role | What they receive |
|---|---|---|
| itacitinib 100 mg | Experimental | itacitinib 100 mg twice a day Receives: Drug: itacitinib |
| itacitinib 200 mg | Experimental | itacitinib 200 mg twice a day Receives: Drug: itacitinib |
| itacitinib 300 mg | Experimental | itacitinib 300 mg once a day Receives: Drug: itacitinib |
| itacitinib 400 mg | Experimental | itacitinib 400 mg once a day Receives: Drug: itacitinib |
| itacitinib 600 mg | Experimental | itacitinib 600 mg once a day Receives: Drug: itacitinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of subjects with >/= 50% reduction in total symptom score in each dose group, as measured by the modified The Myelofibrosis Symptom Assessment Form (MFSAF) v3.0 diary
Measured: Baseline and Week 12
Secondary outcomes (3)
Proportion of subjects with >/= 35% reduction in spleen volume, and mean percent change in spleen volume
Measured: Baseline, Week 12 and Week 24
Proportion of transfusion dependent subjects who exhibit changes in transfusion frequency over any 12 week period on study and proportion of transfusion independent subjects who exhibit changes in hemoglobin level
Measured: Baseline to Week 12; Week 13 to Week 24 through the end of study or study termination visit.
Safety and tolerability of itacitinib as measured by adverse events.
Measured: Every 4-6 weeks through the end of study or early termination visit (approximately 33 weeks exclusive of the extension phase).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2012 (estimated)
- Study start16 Jul 2012
- Primary completion31 Dec 2013
- Study completion29 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MPN (Myeloproliferative Neoplasms)Studies of the same condition, open and under way.
- More trials run by Incyte CorporationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- Incyte Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Albert Assad, MD, Study director, Incyte Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01633372
- Sponsor's protocol ID
- INCB 39110-230
- Status last verified
- Aug 2021
- First submitted
- 26 Jun 2012
- Last updated
- 30 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
Mascarenhas JO, Talpaz M, Gupta V, Foltz LM, Savona MR, Paquette R, Turner AR, Coughlin P, Winton E, Burn TC, O'Neill P, Clark J, Hunter D, Assad A, Hoffman R, Verstovsek S. Primary analysis of a phase II open-label trial of INCB039110, a selective JAK1 inhibitor, in patients with myelofibrosis. Haematologica. 2017 Feb;102(2):327-335. doi: 10.3324/haematol.2016.151126. Epub 2016 Oct 27.
PubMed 27789678
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Multiple Simon 2-Stage Study of Itacitinib Administered Orally to Subjects With Primary Myelofibrosis (PMF), Post Polycythemia Vera Myelofibrosis (PPV-MF) or Post Essential Thrombocythemia Myelofibrosis (PET-MF)
- ClinicalTrials.gov ID
- NCT01633372
- Acronym / sponsor ID
- INCB 39110-230
- Conditions
- MPN (Myeloproliferative Neoplasms)
- Keywords
- Primary Myelofibrosis, PMF, Post Polycythemia Vera Fibrosis, PPV-MF, Post Essential Thrombocythemia Myelofibrosis, PET-MF
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- Incyte CorporationIndustry (pharma, biotech, devices)
- Study start
- 16 Jul 2012 (actual)
- Primary completion
- 31 Dec 2013 (actual)
- Study completion
- 29 Jun 2021 (actual)
- First posted
- 4 Jul 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a study of itacitinib (INCB039110) in patients with myelofibrosis. This study will evaluate safety and efficacy parameters of itacitinib (INCB039110).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| itacitinib 100 mg | Experimental | Drug: itacitinibitacitinib 100 mg twice a day |
| itacitinib 200 mg | Experimental | Drug: itacitinibitacitinib 200 mg twice a day |
| itacitinib 300 mg | Experimental | Drug: itacitinibitacitinib 300 mg once a day |
| itacitinib 400 mg | Experimental | Drug: itacitinibitacitinib 400 mg once a day |
| itacitinib 600 mg | Experimental | Drug: itacitinibitacitinib 600 mg once a day |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Must be diagnosed with PMF, PPV-MF or PET-MF as confirmed by bone marrow biopsy.
- Must score at least 1 point on the Dynamic International Prognostic Scoring System (DIPSS) for prognostic risk factors and have peripheral blast count <10% at both Screening and Baseline hematology assessments.
- Subjects must discontinue all drugs used to treat underlying MF disease no later than Day -14.
- Subjects must have hemoglobin value >/= 8.0g/dL and be willing to receive blood transfusions, have a platelet count >/=50x10^9/L and absolute neutrophil count (ANC) >/= 1x10^9/L.
- Subjects must have palpable spleen or history of splenectomy
Key exclusion criteria (3 listed)
- Women who are pregnant or breastfeeding, and men and women who cannot comply with requirements to avoid fathering a child or becoming pregnant, respectively.
- Subjects with impaired liver function, end stage renal disease on dialysis or clinically significant concurrent infections requiring therapy.
- Subjects with unstable cardiac function or invasive malignancies over the previous 2 years except treated basal or squamous carcinomas of the skin, completely resected intraepithelial carcinoma of the cervix and completely resected papillary thyroid and follicular thyroid cancers.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| itacitinibAlso: INCB039110 | Drug | itacitinib 100 mg, itacitinib 200 mg, itacitinib 300 mg, itacitinib 400 mg, itacitinib 600 mg |
Primary outcome
Proportion of subjects with >/= 50% reduction in total symptom score in each dose group, as measured by the modified The Myelofibrosis Symptom Assessment Form (MFSAF) v3.0 diary
Time frame: Baseline and Week 12
3 secondary outcomes
Proportion of subjects with >/= 35% reduction in spleen volume, and mean percent change in spleen volume
Time frame: Baseline, Week 12 and Week 24
Proportion of transfusion dependent subjects who exhibit changes in transfusion frequency over any 12 week period on study and proportion of transfusion independent subjects who exhibit changes in hemoglobin level
Time frame: Baseline to Week 12; Week 13 to Week 24 through the end of study or study termination visit.
Safety and tolerability of itacitinib as measured by adverse events.
Time frame: Every 4-6 weeks through the end of study or early termination visit (approximately 33 weeks exclusive of the extension phase).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2021.
- Derived from this study: PubMed 27789678Mascarenhas JO, Talpaz M, Gupta V, Foltz LM, Savona MR, Paquette R, Turner AR, Coughlin P, Winton E, Burn TC, O'Neill P, Clark J, Hunter D, Assad A, Hoffman R, Verstovsek S. Primary analysis of a phase II open-label trial of INCB039110, a selective JAK1 inhibitor, in patients with myelofibrosis. Haematologica. 2017 Feb;102(2):327-335. doi: 10.3324/haematol.2016.151126. Epub 2016 Oct 27.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Albert Assad, MD study director
Incyte Corporation
22 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing itacitinib in people with MPN (Myeloproliferative Neoplasms), run by Incyte Corporation at 22 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in United States, Australia, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of subjects with >/= 50% reduction in total symptom score in each dose group, as measured by the modified The Myelofibrosis Symptom Assessment Form (MFSAF) v3.0 diary (time frame: Baseline and Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01633372, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Aug 2021; AzTrials last refreshed its copy on 7 Nov 2026.