Myelodysplastic SyndromesPhase 1/2LIMBERNCT04582539
To Assess the Safety and Tolerability of INCB000928 in Participants With Myelodysplastic Syndromes or Multiple Myeloma
A Phase 1/2 study testing INCB000928 in people with Myelodysplastic Syndromes and Multiple Myeloma, run by Incyte Corporation at 15 sites in 3 countries.
Trial summary
This Phase 1/2, open-label, dose-finding study is intended to evaluate the safety and tolerability, PK, PD, and efficacy of INCB000928 administered as monotherapy in participants with MDS or MM who are transfusion-dependent or present with symptomatic anemia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myelodysplastic Syndromes, Multiple Myeloma, Anemia
- What is being tested?
- INCB000928
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 15 sitesin 3 countries
- Study dates
- 19 Aug 2021to 15 Aug 2024
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Agreement to avoid pregnancy or fathering children.
- Participants who are transfusion-dependent or present with symptomatic anemia
- For MDS participants:
- Ineligible to receive or have not responded to available therapies for anemia such as ESAs or lenalidomide.
- Not requiring cytoreductive therapy other than hydroxyurea.
- BM and peripheral blood myeloblast count < 10%.
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- Histologically confirmed diagnosis of the MDS, CMML and unclassifiable MDS/MPN overlap syndromes.
- For MM participants:
- Histologically confirmed diagnosis of MM.
- After failure of available standard treatments such as alkylating agents, glucocorticoids, immunomodulatory drugs (lenalidomide,pomalidomide, or thalidomide), proteasome inhibitors (bortezomib or carfilzomib), and daratumumab.
Who cannot join
- Any prior allogeneic stem cell transplantation or a candidate for such transplantation.
- Any major surgery within 28 days before the first dose of study drug.
- Any prior chemotherapy, immunomodulatory drug therapy, immunosuppressive therapy, biological therapy, endocrine therapy, targeted therapy, or antibody or hypomethylating agent to treat the participant's disease within 5 half-lives or 28 days (whichever is shorter) before the first dose of study drug.
- Undergoing treatment with another investigational medication or having been treated with an investigational medication within 28 days before the first dose of study drug. -Undergoing treatment with ESAs, granulocyte colony-stimulating factor or granulocyte/macrophage colony-stimulating factor, romiplostin, or eltrombopag at any time within 28 days before the first dose of study drug.
- Undergoing treatment with a strong or potent inhibitor or inducer of CYP3A4/5 within 28 days or 5 half-lives (whichever is longer) before the first dose of study drug or expected to receive such treatment during the study.
- History of clinically significant or uncontrolled cardiac disease.
Show all 9Show fewer
- History or presence of an abnormal ECG that, in the investigator's opinion, is clinically Meaningful.
- Presence of chronic or current active infectious disease requiring systemic antibiotic, antifungal, or antiviral treatment.
- Diagnosis of chronic liver disease.
Trial locations and contacts
15 sites in 3 countries.
15 sites in 3 countries
United States8 sites
University of Cincinnati
Cincinnati, Ohio, 45219
Barbara Ann Karmanos Cancer Hospital
Detroit, Michigan, 48201
Md Anderson Cancer Center
Houston, Texas, 77030
University of Miami
Miami, Florida, 33136
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Tulane Comprehensive Cancer Center
New Orleans, Louisiana, 70112
Stanford Cancer Center
Palo Alto, California, 94304
Florida Cancer Specialists
Sarasota, Florida, 34232
Italy4 sites
L Azienda Ospedaliero-Universitaria Di Bologna Policlinico S. Orsola - Malpighi
Bologna, 40138
Azienda Ospedaliero-Universitaria Careggi (Aouc)
Florence, 50134
Comitato Di Bioetica Della Fondazione Irccs Policlinico San Matteo
Pavia, 27100
Irccs Istituto Clinico Humanitas
Rozzano, 20089
France3 sites
Centre Hospitalier Universitaire de Nantes (Chu de Nantes) - Hotel-Dieu
Nantes, 44093
Hospices Civils de Lyon Centre Hospitalier Lyon Sud
Pierre-Bénite, 69310
Institut Gustave Roussy
Villejuif, 94800
About this study
Official title: A Phase 1/2, Open-Label, Multicenter Study of INCB000928 Administered as a Monotherapy in Participants With Anemia Due to Myelodysplastic Syndromes or Multiple Myeloma
This Phase 1/2, open-label, dose-finding study is intended to evaluate the safety and tolerability, PK, PD, and efficacy of INCB000928 administered as monotherapy in participants with MDS or MM who are transfusion-dependent or present with symptomatic anemia.
- Conditions
- Myelodysplastic Syndromes, Multiple Myeloma, Anemia
- Being tested
- INCB000928
- Keywords
- Myelodysplastic Syndromes, Multiple Myeloma, Anemia, LIMBER
- Medical subject headings
- Myelodysplastic Syndromes, Multiple Myeloma, Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
INCB000928Drug
INCB000928 will be administered once daily.
| Study group | Role | What they receive |
|---|---|---|
| INCB000928 | Experimental | INCB000928 will be administered in participants with MDS or MM who are transfusion-dependent or present with symptomatic anemia. Receives: Drug: INCB000928 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Any Treatment-emergent Adverse Event (TEAE)
An adverse event (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study drug. A TEAE is an AE reported for the first time or the worsening of a pre-existing event after the first dose of study drug.
Measured: up to 950 days
Number of Participants With Any ≥Grade 3 TEAE
The severity of AEs was assessed using Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0) Grades 1 through 5. The investigator made an assessment of intensity for each AE and SAE reported during the study and assigned it to one of the following categories. Grade 1: mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; treatment not indicated. Grade 2: moderate; minimal, local, or noninvasive treatment indicated; limiting age-appropriate activities of daily living. Grade 3: severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care activities of daily living. Grade 4: life-threatening consequences; urgent treatment indicated. Grade 5: fatal.
Measured: up to 950 days
Number of Participants With Dose-limiting Toxicities (DLTs)
A DLT was defined as the occurrence of any protocol-defined toxicities occurring during the first study drug treatment cycle, from C1D1 up to and including Cycle 1 Day 28 (per regimen cycle schedule), except those with a clear alternative explanation (e.g., disease progression) or transient (≤72 hours) abnormal laboratory values without associated clinically significant signs or symptoms based on investigator determination.
Measured: up to Day 28
Maximum Tolerated Dose (MTD)
The MTD was defined as the dose at which the observed DLT rate was closest to the target DLT rate of 28% using an isotonical method that took the assumption of a monotonic dose-toxicity relationship into account. Bayesian optimal interval (BOIN) design was used to determine the MTD for this study. Per the protocol, the stopping rule was either (a) reaching a certain number of participants at one dose level under the early stopping rule or (b) reaching the pre-defined maximum sample size. Dose escalation was to be considered complete only when one of these conditions was met. After completion, the MTD was to be defined as the dose level closest to the target DLT rate. The MTD could not be concluded until the stopping rule was met.
Measured: up to Day 28
Recommended Dose for Expansion (RDE)
RDE doses were defined as pharmacodynamically active. RDE doses were not to have exceeded the MTD defined in each treatment group.
Measured: up to Day 28
Secondary outcomes (18)
Percentage of Participants With Anemia Response
Participants with anemia response were those with a hemoglobin (Hgb) increase of ≥1.5 grams per deciliter (g/dL) relative to baseline for any 8-week period (with each assessment meeting this requirement) during the first 24 weeks of treatment if transfusion independent at baseline. Transfusion-independent participants at baseline were those that did not receive ≥4 units of red blood cell (RBC) transfusions during the 28 days immediately preceding Cycle 1 Day 1 or did not receive ≥4 units of RBC transfusions in the 8 weeks immediately preceding Cycle 1 Day 1, for an Hgb level of <8.5 g/dL, in the absence of bleeding or treatment-induced anemia.
Measured: up to Week 24
Duration of Anemia Response
Duration of anemia response was defined as the interval from the first onset of anemia response to the earliest date of loss of anemia response that persisted for at least 4 weeks or death from any cause. Participants with anemia response were those with a hemoglobin (Hgb) increase of ≥1.5 grams per deciliter (g/dL) relative to baseline for any 8-week period (with each assessment meeting this requirement) during the first 24 weeks of treatment if transfusion independent at baseline. Transfusion-independent participants at baseline were those that did not receive ≥4 units of red blood cell (RBC) transfusions during the 28 days immediately preceding Cycle 1 Day 1 or did not receive ≥4 units of RBC transfusions in the 8 weeks immediately preceding Cycle 1 Day 1, for an Hgb level of <8.5 g/dL, in the absence of bleeding or treatment-induced anemia.
Measured: up to 920 days
Percentage of Participants With RBC-transfusion Independence (TI)
Participants with RBC-transfusion independence were defined as those who did not require any RBC transfusion for at least 8 consecutive weeks during the first 24 weeks of treatment.
Measured: up to Week 24
Duration of RBC-transfusion Independence (TI) Period for Participants Achieving RBC-TI for at Least 8 Consecutive Weeks During the First 24 Weeks of Treatment
Participants with RBC-TI were defined as those who did not require any RBC transfusion for at least 8 consecutive weeks during the first 24 weeks of treatment.
Measured: up to 920 days
Rate of Red Blood Cell (RBC) Transfusion From Week 12 Through Week 24
The rate of RBC transfusion was defined as the average number of RBC units per participant-month during the treatment period.
Measured: from Week 12 through Week 24
The Largest Increase From Baseline in the Mean Hgb Values Over Any Rolling 8-week Treatment Period During the First 24 Weeks of Treatment
Baseline Hgb was measured up to 8 weeks prior to the first dose administration of zilurgisertib. The baseline Hgb was defined as the average of all eligible Hgb assessments. The Hgb assessment(s) within the window from the date received RBC transfusion+1 day to the date received RBC transfusion+14 days that didn't trigger another transfusion were excluded.
Measured: up to Week 24
Overall Response Rate (ORR) in MDS Participants
ORR was defined as the percentage of participants with complete response (CR) or partial response (PR). For MDS, CR: bone marrow with ≤5% myeloblasts with normal maturation of all cell lines; HgB ≥11 g/dl, neutrophils ≥1.0x10^9/Liter (L), platelets ≥100x10^9/L, and no blasts in the peripheral blood. For MDS, PR: all CR criteria, but bone marrow blasts decreased by ≥50% over pretreatment but still >5%; cellularity and morphology not relevant. For MDS/MPN overlap syndromes, CR: bone marrow with ≤5% myeloblasts; no osteomyelofibrosis or ≤Grade 1 fibrosis; white blood cells ≤10X10^9 cells/L, HgB ≥11 g/dL, platelets ≥100x10^9/L/≤450x10^9/L, neutrophils ≥1.0x10^9/L, no blasts, neutrophil precursors reduced to ≤2%, monocytes ≤1x10^9/L in peripheral blood; complete resolution of medullary disease. For MDS/MPN overlap syndromes, PR: normalization of peripheral counts and hepatosplenomegaly with bone marrow blasts reduced by 50%, but remaining >5% of cellularity.
Measured: up to 920 days
Percentage of MDS Participants With an Event of Progression or Death
Participants with MDS/MPN overlap syndromes were excluded from analysis. Data have been reported as the percentage of participants with an event of progression or death rather than median PFS (the interval from the first dose of study drug until the first documented progression or death) because 2 participants had an event of PFS or death. It was pre-specified in the SAP that the number of MDS participants with documented progression or death was to be summarized.
Measured: up to 920 days
Percentage of Participants With an Event of Leukemia or Death
Data have been reported as the percentage of participants with an event of leukemia or death rather than LFS (the interval from the first dose of study drug until the first documented leukemia transformation or death from any cause) because 3 participants had an event of leukemia or death. It was pre-specified in the SAP that the number of participants with leukemia transformation or death was to be summarized.
Measured: up to 920 days
ORR in Multiple Myeloma (MM) Participants
ORR was defined as the percentage of participants with stringent CR, CR, very good PR, and PR.
Measured: up to 920 days
PFS in MM Participants
PFS was defined as the interval from the first dose of study drug until the first documented progression or death.
Measured: up to 920 days
Cmax of Zilurgisertib
Cmax was defined as the maximum concentration of zilurgisertib.
Measured: Days 1 and 15 of Cycle 1: pre-dose; 2, 4, and 6 hours post-dose
Tmax of Zilurgisertib
tmax was defined as the time to the maximum observed concentration of zilurgisertib.
Measured: Days 1 and 15 of Cycle 1: pre-dose; 2, 4, and 6-8 hours post-dose
AUClast of Zilurgisertib
AUClast was defined as the area under the plasma concentration-time curve from time 0 to the last quantifiable measurable plasma concentration of zilurgisertib.
Measured: Days 1 and 15 of Cycle 1: pre-dose; 2, 4, and 6-8 hours post-dose
Ctrough of Zilurgisertib
Ctrough was defined as the lowest concentration of zilurgisertib.
Measured: Day 15 of Cycle 1: pre-dose; 2, 4, and 6-8 hours post-dose
Percentage Change in Hepcidin From Cycle 1 Day 15 to Cycle 7 Day 1
Percentage change was calculated as the ([post-baseline value minus the baseline value] / [baseline value]) * 100.
Measured: from Cycle 1 Day 15 to Cycle 7 Day 1
Change From Baseline in Ferritin
Change from Baseline (CFB) was calculated as the post-Baseline value minus the Baseline value.
Measured: Baseline; Cycle 1 Day 8; Cycle 1 Day 15; Cycles 2, 3, 4, 5, 6, and 7 Day 1
Change From Baseline in Hemoglobin at the End of Treatment
Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Measured: up to 950 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2020
- Study start19 Aug 2021
- Primary completion15 Aug 2024
- Study completion15 Aug 2024
Why it stopped: Strategic Business Decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Myelodysplastic SyndromesStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Incyte Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ekatarine Asatiani, MD, Study director, Incyte Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04582539
- Sponsor's protocol ID
- INCB 00928-105
- Other IDs
- 2020-002771-35
- Acronym
- LIMBER
- Status last verified
- Oct 2025
- First submitted
- 6 Oct 2020
- Last updated
- 22 Oct 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Incyte shares data with qualified external researchers after a research proposal is submitted. These requests are reviewed and approved by a review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/2, Open-Label, Multicenter Study of INCB000928 Administered as a Monotherapy in Participants With Anemia Due to Myelodysplastic Syndromes or Multiple Myeloma
- ClinicalTrials.gov ID
- NCT04582539
- Acronym / sponsor ID
- LIMBER / INCB 00928-105
- Conditions
- Myelodysplastic Syndromes, Multiple Myeloma, Anemia
- Keywords
- Myelodysplastic Syndromes, Multiple Myeloma, Anemia, LIMBER
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Strategic Business Decision
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Incyte CorporationIndustry (pharma, biotech, devices)
- Study start
- 19 Aug 2021 (actual)
- Primary completion
- 15 Aug 2024 (actual)
- Study completion
- 15 Aug 2024 (actual)
- First posted
- 9 Oct 2020 (actual)
- Results
- Posted 22 Oct 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This Phase 1/2, open-label, dose-finding study is intended to evaluate the safety and tolerability, PK, PD, and efficacy of INCB000928 administered as monotherapy in participants with MDS or MM who are transfusion-dependent or present with symptomatic anemia.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| INCB000928 | Experimental | Drug: INCB000928INCB000928 will be administered in participants with MDS or MM who are transfusion-dependent or present with symptomatic anemia. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Agreement to avoid pregnancy or fathering children.
- Participants who are transfusion-dependent or present with symptomatic anemia
- Ineligible to receive or have not responded to available therapies for anemia such as ESAs or lenalidomide.
- Not requiring cytoreductive therapy other than hydroxyurea.
- BM and peripheral blood myeloblast count < 10%.
Key exclusion criteria (9 listed)
- Any prior allogeneic stem cell transplantation or a candidate for such transplantation.
- Any major surgery within 28 days before the first dose of study drug.
- Any prior chemotherapy, immunomodulatory drug therapy, immunosuppressive therapy, biological therapy, endocrine therapy, targeted therapy, or antibody or hypomethylating agent to treat the participant's disease within 5 half-lives or 28 days (whichever is shorter) before the first dose of study drug.
- Undergoing treatment with another investigational medication or having been treated with an investigational medication within 28 days before the first dose of study drug. -Undergoing treatment with ESAs, granulocyte colony-stimulating factor or granulocyte/macrophage colony-stimulating factor, romiplostin, or eltrombopag at any time within 28 days before the first dose of study drug.
- Undergoing treatment with a strong or potent inhibitor or inducer of CYP3A4/5 within 28 days or 5 half-lives (whichever is longer) before the first dose of study drug or expected to receive such treatment during the study.
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 |
|---|---|---|
| INCB000928INCB000928 will be administered once daily. | Drug | INCB000928 |
Primary outcome
Number of Participants With Any Treatment-emergent Adverse Event (TEAE)
Time frame: up to 950 days
An adverse event (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study drug. A TEAE is an AE reported for the first time or the worsening of a pre-existing event after the first dose of study drug.
Number of Participants With Any ≥Grade 3 TEAE
Time frame: up to 950 days
The severity of AEs was assessed using Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0) Grades 1 through 5. The investigator made an assessment of intensity for each AE and SAE reported during the study and assigned it to one of the following categories. Grade 1: mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; treatment not indicated. Grade 2: moderate; minimal, local, or noninvasive treatment indicated; limiting age-appropriate activities of daily living. Grade 3: severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care activities of daily living. Grade 4: life-threatening consequences; urgent treatment indicated. Grade 5: fatal.
Number of Participants With Dose-limiting Toxicities (DLTs)
Time frame: up to Day 28
A DLT was defined as the occurrence of any protocol-defined toxicities occurring during the first study drug treatment cycle, from C1D1 up to and including Cycle 1 Day 28 (per regimen cycle schedule), except those with a clear alternative explanation (e.g., disease progression) or transient (≤72 hours) abnormal laboratory values without associated clinically significant signs or symptoms based on investigator determination.
Maximum Tolerated Dose (MTD)
Time frame: up to Day 28
The MTD was defined as the dose at which the observed DLT rate was closest to the target DLT rate of 28% using an isotonical method that took the assumption of a monotonic dose-toxicity relationship into account. Bayesian optimal interval (BOIN) design was used to determine the MTD for this study. Per the protocol, the stopping rule was either (a) reaching a certain number of participants at one dose level under the early stopping rule or (b) reaching the pre-defined maximum sample size. Dose escalation was to be considered complete only when one of these conditions was met. After completion, the MTD was to be defined as the dose level closest to the target DLT rate. The MTD could not be concluded until the stopping rule was met.
Recommended Dose for Expansion (RDE)
Time frame: up to Day 28
RDE doses were defined as pharmacodynamically active. RDE doses were not to have exceeded the MTD defined in each treatment group.
18 secondary outcomes
Percentage of Participants With Anemia Response
Time frame: up to Week 24
Duration of Anemia Response
Time frame: up to 920 days
Percentage of Participants With RBC-transfusion Independence (TI)
Time frame: up to Week 24
Duration of RBC-transfusion Independence (TI) Period for Participants Achieving RBC-TI for at Least 8 Consecutive Weeks During the First 24 Weeks of Treatment
Time frame: up to 920 days
Rate of Red Blood Cell (RBC) Transfusion From Week 12 Through Week 24
Time frame: from Week 12 through Week 24
The Largest Increase From Baseline in the Mean Hgb Values Over Any Rolling 8-week Treatment Period During the First 24 Weeks of Treatment
Time frame: up to Week 24
Overall Response Rate (ORR) in MDS Participants
Time frame: up to 920 days
Percentage of MDS Participants With an Event of Progression or Death
Time frame: up to 920 days
Percentage of Participants With an Event of Leukemia or Death
Time frame: up to 920 days
ORR in Multiple Myeloma (MM) Participants
Time frame: up to 920 days
PFS in MM Participants
Time frame: up to 920 days
Cmax of Zilurgisertib
Time frame: Days 1 and 15 of Cycle 1: pre-dose; 2, 4, and 6 hours post-dose
Tmax of Zilurgisertib
Time frame: Days 1 and 15 of Cycle 1: pre-dose; 2, 4, and 6-8 hours post-dose
AUClast of Zilurgisertib
Time frame: Days 1 and 15 of Cycle 1: pre-dose; 2, 4, and 6-8 hours post-dose
Ctrough of Zilurgisertib
Time frame: Day 15 of Cycle 1: pre-dose; 2, 4, and 6-8 hours post-dose
Percentage Change in Hepcidin From Cycle 1 Day 15 to Cycle 7 Day 1
Time frame: from Cycle 1 Day 15 to Cycle 7 Day 1
Change From Baseline in Ferritin
Time frame: Baseline; Cycle 1 Day 8; Cycle 1 Day 15; Cycles 2, 3, 4, 5, 6, and 7 Day 1
Change From Baseline in Hemoglobin at the End of Treatment
Time frame: up to 950 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Incyte shares data with qualified external researchers after a research proposal is submitted. These requests are reviewed and approved by a review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.
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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.
Ekatarine Asatiani, MD study director
Incyte Corporation
15 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing INCB000928 in people with Myelodysplastic Syndromes and Multiple Myeloma, run by Incyte Corporation at 15 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 10 inclusion and 9 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: stopped early, as of the sponsor's last update on 22 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in United States, Italy, France. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Yes. Results are posted in the registry (first posted 22 Oct 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With Any Treatment-emergent Adverse Event (TEAE) (time frame: up to 950 days). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Oct 2025.