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
EU CT Number:
2022-502514-86-00
Sponsor:
Incyte Corporation
Collaborator:
N/A
Study Contact Information:
1.855.463.3463 or [email protected]
Recruiting
Subscribe to UpdatesContact Us

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
    Go to page

    Key Inclusion and Exclusion Criteria

    Inclusion Criteria

    • Inclusion Criteria:
    • Life expectancy > 6 months.

    Exclusion Criteria

    Requirements information
    Inclusion Criteria
    • Inclusion Criteria:
    • • Life expectancy > 6 months.
    • • Willingness to undergo a pretreatment and regular on-study BM biopsies and aspirates (as appropriate to disease).
    • • Existing documentation from a qualified local laboratory of CALR exon-9 mutation.
    • • Participants with MF and ET as defined in the protocol.
    • Exclusion Criteria:
    • • Presence of any hematological malignancy other than ET, PMF, or post-ET MF.
    • • Active invasive malignancy over the previous 2 years.
    • • Active HBV/HCV, HIV.
    • • History of clinically significant or uncontrolled cardiac disease.
    • • Has undergone any prior allogenic or autologous stem-cell transplantation or such transplantation is planned.
    • • Laboratory values outside the Protocol-defined ranges.
    • • Participants undergoing treatment with G-CSF, GM-CSF, or TPO-R agonists at any time within 4 weeks before the first dose of study treatment.
    • • Prior history of major bleeding, or thrombosis within the last 3 months prior to study enrollment.
    • • Any prior chemotherapy, immunomodulatory drug therapy, immunosuppressive therapy, biological therapy, endocrine therapy, targeted therapy, antibody, or hypomethylating agent used to treat the participant's disease within 5 half-lives or 28 days (whichever is shorter) before the first dose of study treatment.
    • • For TGBs only: Undergoing treatment with a potent/strong inhibitor or inducer of CYP 3A4/5 within 14 days or 5 half-lives (whichever is longer) before the first dose of study treatment, or expected to receive such treatment during the study.
    • Other protocol-defined Inclusion/Exclusion Criteria may apply.

    Protocol Summary

    Incyte Study ID:
    INCA 33989-101
    Primary Purpose:
    Treatment
    Allocation:
    Non-randomized
    Study Design:
    Sequential Assignment
    Masking:
    None (Open Label)
    Interventions:
  • Drug: INCA033989
  • Drug: Ruxolitinib
    • 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