Advanced/Metastatic

A Dose-escalation Study in Subjects With Advanced Malignancies

Incyte Study ID:
INCB 24360-101
CT.gov ID:
NCT01195311
View Results Summary
Eudra ID:
N/A
Sponsor:
Incyte Corporation
Collaborator:
N/A
Study Contact Information:
1.855.463.3463
Study Complete
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Clinical Study Purpose

This is an open label, dose escalation study using a 3 + 3 design to determine if INCB024360 (study drug) is safe, well-tolerated and effective in patients with advanced malignancies. Patients will be enrolled and treated in cohorts of three and each observed a minimum of 28 days before the next group is enrolled and may begin to receive study drug. For subject safety, the first subject in each cohort will be administered drug for one week before the next two subjects in the cohort can begin drug administration. Doses will be escalated unless a dose-limiting toxicity (DLT) is observed in one of three subjects.

An expanded cohort of up to 15 patients may be recruited to further explore safety at the 'maximum tolerated dose' or at a lower, pharmacologically active, dose.

Clinical Study Summary

MEDICAL CONDITION(S)
  • Advanced/Metastatic
    • PRODUCT
  • Drug: INCB024360
    • COLLABORATORS
    N/A
    DATE
    Jul 2010 - May 2013
    TYPE
    Interventional
    PHASE
    Phase 1
    SEX
    Female & Male
    AGE
    18+ years
    ACCEPTS HEALTHY VOLUNTEERS
    No

    Clinical Study Locations

    Name
    Contact Us
    Name
    Chicago, IL, US
    Name
    Philadelphia, PA, US

    Key Inclusion and Exclusion Criteria

    Inclusion Criteria

    • Subjects with neoplastic disease refractory to currently available therapies or for which no effective treatment is available
    • Subjects with life expectancy of 12 weeks or longer.

    Exclusion Criteria

    • Subjects who received any anti-cancer medications in the 21 days prior to receiving their first dose of study medication or 6 weeks for mitomycin-C or nitrosoureas.
    • Subjects with history of brain metastases or spinal cord compression.

    Protocol Summary

    Incyte Study ID:
    INCB 24360-101
    Primary Purpose:
    Treatment
    Allocation:
    N/A
    Study Design:
    Single Group Assignment
    Masking:
    None (Open Label)
    Interventions:
    Drug
    Enrollment:
    52
    Primary Outcome
    Open

    Safety and tolerability as measured by adverse events and dose limiting toxicities

    Timeframe: Measured from baseline through follow-up period (measured during cycle 1 weekly and bi monthly thereafter)

    Secondary Outcome
    Open

    Tumor assessment as measured by RECIST criteria

    Timeframe: Measured from baseline through treatment cessation. (Measured every other cycle and end of study)

    Measurement of IDO inhibition in whole blood measured through blood sampling.

    Timeframe: Cycle 1, Day 1 and each 28 day subsequent cycle at Day 1

    PK analysis

    Timeframe: Full PK at Days 1, 8 (trough only), 15 at Cycle 1 and trough at each subsequent cycle at Day 1