22 Participants Needed

INCB000928 for Myelodysplastic Syndrome

(LIMBER Trial)

Recruiting at 18 trial locations
IC
IC
Overseen ByIncyte Corporation Call Center (ex-US)
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 1 JurisdictionThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new drug, INCB000928, for patients with MDS or MM who need regular blood transfusions or have severe anemia. The goal is to see if the drug can improve blood cell counts and reduce the need for transfusions by acting on specific pathways in the body.

Will I have to stop taking my current medications?

Yes, you may need to stop taking certain medications before joining the trial. Specifically, you cannot have had chemotherapy, immunomodulatory drugs, or other specified treatments within 28 days or 5 half-lives before starting the study drug. Also, you cannot be on certain other medications like strong CYP3A4/5 inhibitors or inducers during the study.

What makes the drug INCB000928 unique for treating myelodysplastic syndrome?

INCB000928, also known as Zilurgisertib, is a novel treatment option for myelodysplastic syndrome (MDS) that targets both the malignant blood cells and their surrounding environment, potentially overcoming resistance to current therapies. This approach is part of a new wave of treatments that aim to improve patient outcomes by addressing multiple aspects of the disease.12345

Who Is on the Research Team?

EA

Ekatarine Asatiani, MD

Principal Investigator

Incyte Corporation

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Agreement to avoid pregnancy or fathering children
I have MDS and only use hydroxyurea for treatment.
I need regular blood transfusions or have symptoms of anemia.
See 5 more

Exclusion Criteria

I haven't taken any blood cell-boosting drugs in the last 28 days.
I have a serious heart condition that is not under control.
You have had or currently have a significant heart rhythm problem as determined by the study doctor.
See 7 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive INCB000928 as monotherapy to evaluate safety, tolerability, PK, PD, and efficacy

Approximately up to 7 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • INCB000928
Trial Overview 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.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: INCB000928Experimental Treatment1 Intervention

INCB000928 is already approved in United States for the following indications:

🇺🇸
Approved in United States as Zilurgisertib for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

Incyte Corporation

Lead Sponsor

Trials
408
Recruited
66,800+
Steven Stein profile image

Steven Stein

Incyte Corporation

Chief Medical Officer since 2015

MD from University of Witwatersrand

Hervé Hoppenot profile image

Hervé Hoppenot

Incyte Corporation

Chief Executive Officer since 2014

MBA from ESSEC Business School

Published Research Related to This Trial

Myelodysplastic syndrome (MDS) is a complex blood disorder with a significant risk of progressing to acute myeloid leukemia (AML) and currently lacks a proven curative treatment.
Emerging biological therapies that target both the cancerous blood cells and their surrounding environment show promise in overcoming resistance to existing treatments and may improve patient outcomes.
New options in the treatment of myelodysplastic syndrome.Grudeva-Popova, J.[2007]
Several new therapeutic agents are being developed for myelodysplastic syndromes (MDS), including clofarabine, ezatiostat, tipifarnib, laromustine, and histone deacetylase inhibitors, each with different mechanisms of action.
Despite the challenges of MDS, which often leads to complications within 3 to 5 years of diagnosis, the ongoing clinical trials suggest that new treatment options may become available in the next 5 to 10 years.
Novel therapies for myelodysplastic syndromes.Steensma, DP.[2018]

Citations

New options in the treatment of myelodysplastic syndrome. [2007]
Age and comorbidities deeply impact on clinical outcome of patients with myelodysplastic syndromes. [2015]
The new diagnostic criteria for myelodysplasia-related acute myeloid leukemia is useful for predicting clinical outcome: comparison of the 4th and 5th World Health Organization classifications. [2022]
Health-related Quality of Life Profile of Newly Diagnosed Patients With Myelodysplastic Syndromes by Age, Sex, and Risk Group: A Real-world Study by the GIMEMA. [2023]
Novel therapies for myelodysplastic syndromes. [2018]
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