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

Incyte logo

Incyte

Status and phase

Active, not recruiting
Phase 2
Phase 1

Conditions

Anemia
Multiple Myeloma
Myelodysplastic Syndromes

Treatments

Drug: INCB000928

Study type

Interventional

Funder types

Industry

Identifiers

NCT04582539
INCB 00928-105

Details and patient eligibility

About

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.

Enrollment

22 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • 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%.
  • 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.

Exclusion criteria

  • 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.
  • 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 design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Sequential Assignment

Masking

None (Open label)

22 participants in 1 patient group

INCB000928
Experimental group
Description:
INCB000928 will be administered in participants with MDS or MM who are transfusion-dependent or present with symptomatic anemia.
Treatment:
Drug: INCB000928

Trial contacts and locations

15

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Central trial contact

Incyte Corporation Call Center (US); Incyte Corporation Call Center (ex-US)

Data sourced from clinicaltrials.gov

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