Myeloproliferative neoplasms (MPN)

A Study to Evaluate INCA033989 Administered as a Monotherapy or in Combination With Ruxolitinib in Participants With Myeloproliferative Neoplasms

Incyte Study ID:
INCA 33989-101
CT.gov ID:
NCT05936359
Eudra ID:
N/A
Sponsor:
Incyte Corporation
Collaborator:
N/A
Study Contact Information:
1.855.463.3463 or [email protected]
Recruiting
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Clinical Study Purpose

This study is being conducted to evaluate the safety, tolerability, and dose-limiting toxicity (DLT) and determine the maximum tolerated dose (MTD) and/or recommended dose(s) for expansion (RDE) of INCA033989 administered as a monotherapy or in combination with ruxolitinib in participants with myeloproliferative neoplasms.

Clinical Study Summary

MEDICAL CONDITION(S)
  • Myeloproliferative neoplasms (MPN)
    • PRODUCT
  • Drug: INCA033989
  • Drug: Ruxolitinib
    • COLLABORATORS
    N/A
    DATE
    Sep 2023 - Feb 2028
    TYPE
    Interventional
    PHASE
    Phase 1
    SEX
    Female & Male
    AGE
    18+ years
    ACCEPTS HEALTHY VOLUNTEERS
    No

    Clinical Study Locations

    Name
    Status
    Contact Us
    Name
    ROYAL ADELAIDE HOSPITAL
    ADELAIDE, SA, Australia, 05000
    Status
    Recruiting
    Name
    ROYAL BRISBANE AND WOMEN'S HOSPITAL
    HERSTON, QLD, Australia, 04029
    Status
    Recruiting
    Name
    THE ALFRED HOSPITAL
    MELBOURNE, VIC, Australia, 03004
    Status
    Recruiting
    Name
    PETER MACCALLUM CANCER CENTRE
    MELBOURNE, VIC, Australia, 03000
    Status
    Recruiting
    Name
    PRINCESS MARGARET CANCER CENTER
    TORONTO, ON, Canada, M5G 2M9
    Status
    Recruiting
    Name
    HOPITAL MAISONNEUVE-ROSEMONT, MONTREAL, QC
    MONTREAL, QC, Canada, H1T 2M4
    Status
    Recruiting

    Key Inclusion and Exclusion Criteria

    Inclusion Criteria

    • Life expectancy > 6 months.
    • Willingness to undergo a pretreatment and regular on-study BM biopsies and aspirates (as appropriate to disease).

    Exclusion Criteria

    • Presence of any hematological malignancy other than ET, PMF, or post-ET MF.
    • Active invasive malignancy over the previous 2 years.

    Protocol Summary

    Incyte Study ID:
    INCA 33989-101
    Primary Purpose:
    Treatment
    Allocation:
    Non-randomized
    Study Design:
    Sequential Assignment
    Masking:
    None (Open Label)
    Interventions:
    Drug
    Enrollment:
    225
    Primary Outcome
    Open

    Number of participants with Dose Limiting Toxicities (DLTs)

    Timeframe: Up to 28 days

    Number of participants with Treatment-emergent Adverse Events (TEAEs)

    Timeframe: Up to 3 years and 60 days

    Number of participants with TEAEs leading to dose modification or discontinuation

    Timeframe: Up to 3 years and 60 days

    Secondary Outcome
    Open

    Participants with MF: Response using the revised IWG-MRT and ELN response criteria for MF

    Timeframe: Up to 3 years and 60 days

    Participants With MF: Percentage of participants achieving spleen volume reduction as defined in the protocol

    Timeframe: Up to 3 years and 60 days

    Participants with MF with symptomatic anemia: Anemia Response

    Timeframe: Up to 3 years and 60 days

    Participants With ET: Response Rate

    Timeframe: Up to 3 years and 60 days

    Participants With ET: Mean change from baseline of total symptom score (TSS)

    Timeframe: Up to 3 years and 60 days

    Mean change in disease-related allele burden

    Timeframe: Up to 3 years and 60 days

    Pharmacokinetics Parameter: Cmax of INCA33989

    Timeframe: Up to 3 years and 60 days

    Pharmacokinetics Parameter: Tmax of INCA033989

    Timeframe: Up to 3 years and 60 days

    Pharmacokinetics Parameter: Cmin of INCA33989

    Timeframe: Up to 3 years and 60 days

    Pharmacokinetics Parameter: AUC(0-t) of INCA33989

    Timeframe: Up to 3 years and 60 days

    Pharmacokinetics Parameter: AUC 0-∞ of INCA33989

    Timeframe: Up to 3 years and 60 days

    Pharmacokinetics Parameter: CL/F of INCA33989

    Timeframe: Up to 3 years and 60 days

    Pharmacokinetics Parameter: Vz/F of INCA33989

    Timeframe: Up to 3 years and 60 days

    Pharmacokinetics Parameter: t1/2 of INCA33989

    Timeframe: Up to 3 years and 60 days