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

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ClinicalTrials.gov Identifier: NCT04582539
Recruitment Status : Recruiting
First Posted : October 9, 2020
Last Update Posted : August 24, 2021
Sponsor:
Information provided by (Responsible Party):
Incyte Corporation

Brief 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.

Condition or disease Intervention/treatment Phase
Myelodysplastic Syndromes Multiple Myeloma Anemia Drug: INCB000928 Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: N/A
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : August 19, 2021
Estimated Primary Completion Date : December 22, 2023
Estimated Study Completion Date : December 22, 2023


Arm Intervention/treatment
Experimental: INCB000928
INCB000928 will be administered in participants with MDS or MM who are transfusion-dependent or present with symptomatic anemia.
Drug: INCB000928
INCB000928 will be administered once daily.




Primary Outcome Measures :
  1. Number of treatment-related adverse events [ Time Frame: Approximately up to 7 months ]
    To determine the safety and tolerability of INCB000928 administered as monotherapy in participants with MDS or MM.


Secondary Outcome Measures :
  1. Proportion of participants with anemia response (for TI patients at baseline) [ Time Frame: Approximately up to 7 months ]
    Defined as an Hgb increase.

  2. Duration of anemia response [ Time Frame: Approximately up to 7 months ]
    Defined as the interval from the first onset of anemia response to the earliest date of loss of anemia response.

  3. Proportion of participants with RBC-TI (for TD at baseline) [ Time Frame: Approximately up to 7 months ]
    Defined as the absence of any RBC transfusion

  4. Duration of RBC-TI period [ Time Frame: Approximately up to 7 months ]
    Defined as duration of time for which participants are transfusion independent

  5. Rate of RBC transfusion [ Time Frame: Through weeks 12 and 24 ]
    Defined as the average number of RBC units

  6. Increase in mean Hgb [ Time Frame: Approximately up to 7 months ]
    Defined as the increase from baseline in the mean Hgb

  7. MDS Participants only : Overall Response Rate [ Time Frame: Approximately up to 7 months ]
    Defined as the proportion of participants with CR or PR

  8. MDS Participants only : Progression Free Survival [ Time Frame: Approximately up to 7 months ]
    Defined as the interval from the first dose of study drug until the first documented progression or death

  9. MDS Participants only : Leukemia Free Survival [ Time Frame: Approximately up to 7 months ]
    Defined as the interval from the first dose of study drug until the first documented leukemia transformation or death from any cause.

  10. MM participants only : Overall Response Rate [ Time Frame: Approximately up to 7 months ]
    Defined as the proportion of participants with stringent CR, CR, very good PR, and PR

  11. MM Participants only : Progression Free Survival [ Time Frame: Approximately up to 7 months ]
    Defined as the interval from the first dose of study drug until the first documented progression or death.

  12. Cmax [ Time Frame: C1D1 and C1D15 ]
    Maximum plasma concentration of INCB000928

  13. Tmax [ Time Frame: C1D1 and C1D15 ]
    Time to reach maximum (peak) plasma concentration of INCB000928

  14. AUC0-t [ Time Frame: C1D1 and C1D15 ]
    Area under the plasma concentration-time curve from time = 0 to the last measurable concentration at time = t.

  15. Hepcidin levels [ Time Frame: Approximately upto 7 months ]
    Effect of INCB000928 on hepcidin levels

  16. Iron Homeostasis [ Time Frame: Approximately upto 7 months ]
    Effect of INCB000928 on iron homeostasis.

  17. Erythropoiesis [ Time Frame: Approximately upto 7 months ]
    Effect of INCB000928 on erythropoiesis.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04582539


Contacts
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Contact: Incyte Corporation Call Center (US) 1.855.463.3463 medinfo@incyte.com
Contact: Incyte Corporation Call Center (ex-US) globalmedinfo@incyte.com

Locations
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United States, Louisiana
Tulane Comprehensive Cancer Center Recruiting
New Orleans, Louisiana, United States, 70112
United States, Michigan
Barbara Ann Karmanos Cancer Hospital Recruiting
Detroit, Michigan, United States, 48201
United States, Ohio
University of Cincinnati Recruiting
Cincinnati, Ohio, United States, 45219
United States, Tennessee
Vanderbilt University Medical Center Recruiting
Nashville, Tennessee, United States, 37232
United States, Texas
Md Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
France
Centre Hospitalier Universitaire de Nantes (Chu de Nantes) - Hotel-Dieu Recruiting
Nantes, France, 44093
Hospices Civils de Lyon Centre Hospitalier Lyon Sud Recruiting
Pierre Benite, France, 69310
Italy
Azienda Ospedaliero-Universitaria Careggi (Aouc) Recruiting
Firenze, Italy, 50134
Irrcs Instituto Clinico Humanitas Recruiting
Rozzano, Italy, 20089
Sponsors and Collaborators
Incyte Corporation
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Responsible Party: Incyte Corporation
ClinicalTrials.gov Identifier: NCT04582539    
Other Study ID Numbers: INCB 00928-105
First Posted: October 9, 2020    Key Record Dates
Last Update Posted: August 24, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Time Frame: Data will be shared after the primary publication or 2 years after the study has ended for market authorized products and indications.
Access Criteria: Data from eligible studies will be shared with qualified researchers according to the criteria and process described in the Data Sharing section of the www.incyteclinicaltrials.com website. For approved requests, the researchers will be granted access to anonymized data under the terms of a data sharing agreement.
URL: https://www.incyte.com/our-company/compliance-and-transparency

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Incyte Corporation:
Myelodysplastic Syndromes
Multiple Myeloma
Anemia
Additional relevant MeSH terms:
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Multiple Myeloma
Neoplasms, Plasma Cell
Preleukemia
Anemia
Myelodysplastic Syndromes
Syndrome
Disease
Pathologic Processes
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Bone Marrow Diseases
Precancerous Conditions