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INCB000928 for Myelodysplastic Syndrome (LIMBER Trial)

Phase 1 & 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

For MDS participants: Not requiring cytoreductive therapy other than hydroxyurea

Participants who are transfusion-dependent or present with symptomatic anemia

Timeline

Screening 3 weeks

Treatment Varies

Follow Up approximately upto 7 months

Awards & highlights

LIMBER Trial Summary

This trial is testing a new drug to treat myelodysplastic syndrome or multiple myeloma in patients who need blood transfusions or have anemia symptoms.

Who is the study for?

This trial is for adults with Myelodysplastic Syndromes (MDS) or Multiple Myeloma (MM) who need regular blood transfusions or have anemia symptoms. MDS patients must have tried other anemia treatments without success and can't be on certain therapies. MM patients should have already tried standard treatments without success. Participants must not be pregnant, planning to become pregnant, or father a child.Check my eligibility

What is being tested?

The study tests INCB000928's safety and how well it works as a single therapy in people with MDS or MM who are dependent on transfusions or suffer from symptomatic anemia. It's a Phase 1/2 trial where researchers will also look at how the body processes the drug and its effects on the disease.See study design

What are the potential side effects?

Specific side effects of INCB000928 aren't listed, but common ones for cancer drugs include nausea, fatigue, risk of infection, bleeding issues, liver problems, allergic reactions and changes in heart rhythm which will be monitored throughout the trial.

LIMBER Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have MDS and only use hydroxyurea for treatment.

Select...

I need regular blood transfusions or have symptoms of anemia.

Select...

My diagnosis of multiple myeloma is confirmed through tissue examination.

Select...

I have MDS and treatments like ESAs or lenalidomide didn’t work for me.

Select...

I have MM and standard treatments like chemotherapy or immunotherapy didn't work for me.

Select...

I have been diagnosed with MDS, CMML, or an unclassifiable MDS/MPN overlap.

LIMBER Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ approximately upto 7 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~approximately upto 7 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately upto 7 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

Number of treatment-related adverse events

Secondary outcome measures

AUC0-t

Cmax

Duration of RBC-TI period

+14 more

LIMBER Trial Design

1Treatment groups

Experimental Treatment

Group I: INCB000928Experimental Treatment1 Intervention

INCB000928 will be administered in participants with MDS or MM who are transfusion-dependent or present with symptomatic anemia.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

INCB000928

2021

Completed Phase 1

~50

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

Incyte CorporationLead Sponsor

364 Previous Clinical Trials

55,143 Total Patients Enrolled

4 Trials studying Anemia

138 Patients Enrolled for Anemia

Ekatarine Asatiani, MDStudy DirectorIncyte Corporation

Media Library

INCB000928 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT04582539 — Phase 1 & 2

Anemia Research Study Groups: INCB000928

Anemia Clinical Trial 2023: INCB000928 Highlights & Side Effects. Trial Name: NCT04582539 — Phase 1 & 2

INCB000928 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04582539 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participating locations are currently engaged in this trial?

"This clinical trial is presently enrolling patients from 5 different sites, which are located in Cincinnati, Miami, and Palo Alto among other places. To make participation easier on participants it's advisable to select the location closest to you."

Answered by AI

Are there any slots available to partake in this medical trial at present?

"Clinicaltrials.gov has confirmed that the recruitment process for this trial is still underway, having commenced on August 19th 2021 and been updated as recently as October 17th 2022."

Answered by AI

How many participants is the trial currently accommodating?

"In order to complete this medical trial, 80 eligible patients are needed. Potential participants can find a clinical site at either the University of Cincinnati in Ohio or University of Miami in Florida."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

To Assess the Safety and Tolerability of INCB000928 in Participants With Myelodysplastic Syndromes or Multiple Myeloma

2021. "To Assess the Safety and Tolerability of INCB000928 in Participants With Myelodysplastic Syndromes or Multiple Myeloma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04582539.

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