Advanced/Metastatic

Itacitinib combined with INCB024360 and/or Itacitinib combined with INCB050465 in Advanced Solid Tumors

Incyte Study ID:
39110-106
CT.gov ID:
NCT02559492
Eudra ID:
N/A
Sponsor:
Incyte Corporation
Collaborator:
N/A
Study Contact Information:
1.855.463.3463
Other
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Clinical Study Purpose

This is an open-label, Phase 1b, platform study in subjects with advanced or metastatic solid tumors. The study will be divided into 3 parts (Part 1a, Part 1b, and Part 2). Part 1a will evaluate a JAK inhibitor with JAK1 selectivity (Itacitinib) in combination with an IDO1 inhibitor (epacadostat; INCB024360; Group A) and Itacitinib in combination with a PI3K-delta inhibitor (INCB050465; Group B) to determine the MTD or PAD and the recommended Part 1b doses for each combination. Once the recommended dose has been identified for each treatment group in Part 1a, subjects with advanced solid tumors will be enrolled into expansion cohorts based upon prior treatment history with a PD-1 pathway-targeted agent (Part 1b). In Part 2, additional expansion cohorts will be enrolled to further evaluate lower doses of itacitinib and INCB050465 in subjects with select tumor types.

Clinical Study Summary

MEDICAL CONDITION(S)
  • Advanced/Metastatic
    • PRODUCT
  • Drug: Itacitinib
  • Drug: Epacadostat
  • Drug: INCB050465
    • COLLABORATORS
    N/A
    DATE
    Nov 2015 - Sep 2018
    TYPE
    Interventional
    PHASE
    Phase 1
    SEX
    Female & Male
    AGE
    18+ years
    ACCEPTS HEALTHY VOLUNTEERS
    No

    Clinical Study Locations

    Name
    Contact Us
    Name
    Duarte, California, US
    Name
    Denver, Colorado, US
    Name
    New Haven, CT, US
    Name
    Tampa, Florida, US
    Name
    Chicago, IL, US
    Name
    Rochester, MN, US

    Key Inclusion and Exclusion Criteria

    Inclusion Criteria

    • Male or female, age 18 years or older.
    • Willingness to provide written informed consent for the study.

    Exclusion Criteria

    • Laboratory parameters not within the protocol-defined range.
    • Receipt of anticancer medications or investigational drugs within a defined interval before the first administration of study drug.

    Protocol Summary

    Incyte Study ID:
    39110-106
    Primary Purpose:
    Treatment
    Allocation:
    Non-randomized
    Study Design:
    Parallel Assignment
    Masking:
    None (Open Label)
    Interventions:
    Drug
    Enrollment:
    142
    Primary Outcome
    Open

    Number of Participants With Dose Limiting Toxicities (DLTs)

    Timeframe: Baseline through 21 days

    Secondary Outcome
    Open

    Objective response rate (ORR)

    Timeframe: Every 9 weeks for duration of study participation which is estimated to be 18 months

    Progression Free Survival (PFS)

    Timeframe: Every 9 weeks for duration of study participation which is estimated to be 18 months

    Duration of response (DOR)

    Timeframe: Every 9 weeks for duration of study participation which is estimated to be 18 months