Breast Cancer

Safety and Efficacy of INCB007839 With Trastuzumab and Vinorelbine in Patients With Metastatic HER2+ Breast Cancer

Incyte Study ID:
INCB 7839-204
CT.gov ID:
NCT01254136
Eudra ID:
N/A
Sponsor:
Incyte Corporation
Collaborator:
N/A
Study Contact Information:
1.855.463.3463
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Clinical Study Purpose

This Phase I/II study is designed to assess the safety and therapeutic effect of INCB007839 in combination with trastuzumab and vinorelbine in patients with metastatic HER2+ breast cancer.

Clinical Study Summary

MEDICAL CONDITION(S)
  • Breast Cancer
    • PRODUCT
  • Drug: INCB007839 300mg BID
  • Drug: Trastuzumab
  • Drug: Vinorelbine
    • COLLABORATORS
    N/A
    DATE
    Oct 2010 - Sep 2011
    TYPE
    Interventional
    PHASE
    Phase 1/Phase 2
    SEX
    Female only
    AGE
    18+ years
    ACCEPTS HEALTHY VOLUNTEERS
    No

    Clinical Study Locations

    Location
    Status
    Location
    Fayetteville, AR, US
    Status
    Completed
    Location
    Duarte, CA, US
    Status
    Completed
    Location
    Denver, CO, US
    Status
    Completed
    Location
    Davie, FL, US
    Status
    Completed
    Location
    Jacksonville, FL, US
    Status
    Completed
    Location
    Detroit, MI, US
    Status
    Completed

    Key Inclusion and Exclusion Criteria

    Inclusion Criteria

    • Subject with diagnosis of metastatic (or locally recurrent-inoperable) breast cancer
    • Subject with histological HER2+ status as determined by FISH with a gene amplification score of ≥ 2.2

    Exclusion Criteria

    • Subject with Left ventricular ejection fraction (LVEF) below institutional normal range
    • Subject with metastasis to the central nervous system UNLESS asymptomatic and clinically stable

    Protocol Summary

    Incyte Study ID:
    INCB 7839-204
    Primary Purpose:
    Treatment
    Allocation:
    Non-randomized
    Study Design:
    Single Group Assignment
    Masking:
    None (Open Label)
    Interventions:
    Drug
    Enrollment:
    20
    Primary Outcome
    Open

    Evaluation of safety and tolerabilty as determined by monitoring the frequency and severity of adverse events (AEs) and performing clinical assessments and laboratory investigations.

    Timeframe: Measured monthly starting at Baseline (estimated duration 6-9 months)

    Secondary Outcome
    Open

    Overall objective response rate assessed by RECIST criteria

    Timeframe: Measured at Baseline, Cycle 4 and approximately every 9 weeks after (estimated duration 6-9 months)