Advanced/Metastatic

An Open-Label, Dose-Escalation Study of INCB054329 in Patients With Advanced Malignancies

Incyte Study ID:
INCB 54329-101
CT.gov ID:
NCT02431260
Eudra ID:
N/A
Sponsor:
Incyte Corporation
Collaborator:
N/A
Study Contact Information:
1-855-463-3463
Other
Subscribe to Updates

Clinical Study Purpose

This was a study of INCB054329 given to patients with advanced malignancies that were conducted in three treatment groups. Each treatment group had a dose escalation (Part 1) and a dose expansion (Part 3), two of the treatment groups also had an intra-patient dose titration (Part 2).

Clinical Study Summary

MEDICAL CONDITION(S)
  • Advanced/Metastatic
    • PRODUCT
  • Drug: INCB054329 Monotherapy
    • COLLABORATORS
    N/A
    DATE
    Apr 2015 - Jan 2018
    TYPE
    Interventional
    PHASE
    Phase 1/Phase 2
    SEX
    Female & Male
    AGE
    18+ years
    ACCEPTS HEALTHY VOLUNTEERS
    No

    Key Inclusion and Exclusion Criteria

    Inclusion Criteria

    • Confirmed diagnosis of advanced malignancy:
    • o Treatment Group A (TGA): Part 1 and Part 2: Any advanced solid tumor or lymphoma; Part 3: Histologically confirmed disease in specific solid tumors and lymphomas

    Exclusion Criteria

    • Inadequate hematopoietic, liver, endocrine or renal function
    • Receipt of anticancer medications or investigational drugs within the following interval before the first administration of study drug:

    Clinical Study Locations

    Location
    Status
    Location
    Cedars-Sinai Medical Center
    Los Angeles, CA, US, 90048
    Status
    Completed
    Location
    University of California, San Francisco, Medical Center at Mount Zion
    San Francisco, California, US, 94115
    Status
    Completed
    Location
    Sarah Cannon Research Institute Research Center
    Denver, CO, US, 80218
    Status
    Completed
    Location
    The University of Chicago Medical Center
    Chicago, Illinois, US, 60637
    Status
    Completed
    Location
    Northwestern Memorial Hospital
    Chicago, Illinois, US, 60611
    Status
    Completed
    Location
    Horizon Oncology Center
    Lafayette, IN, US, 47905
    Status
    Completed

    Protocol Summary

    Incyte Study ID:
    INCB 54329-101
    Primary Purpose:
    Treatment
    Allocation:
    N/A
    Study Design:
    Sequential Assignment
    Masking:
    None (Open Label)
    Interventions:
    Drug
    Enrollment:
    69
    Primary Outcome
    Open
    Secondary Outcome
    Open