Clinical Trials /

Study of Poziotinib in Patients With HER2-Positive Metastatic Breast Cancer

NCT02659514

Description:

The purpose of this study is to establish the dose regimen and evaluate the preliminary efficacy and the safety/tolerability of poziotinib in patients with HER2-positive metastatic breast cancer who have received at least 2 prior HER2-directed treatment regimens.

Related Conditions:
  • Breast Carcinoma
Recruiting Status:

Active, not recruiting

Phase:

Phase 2

Trial Eligibility

Document

Study of Poziotinib in Patients With <span class="go-doc-concept go-doc-biomarker">HER2</span>-Positive <span class="go-doc-concept go-doc-disease">Metastatic Breast Cancer</span>

Title

  • Brief Title: Study of Poziotinib in Patients With HER2-Positive Metastatic Breast Cancer
  • Official Title: A Phase 2 Study of Poziotinib in Patients With HER2-Positive Metastatic Breast Cancer (MBC) Who Have Received Prior HER2 Regimens for MBC
  • Clinical Trial IDs

    NCT ID: NCT02659514

    ORG ID: SPI-POZ-201

    Trial Conditions

    Breast Cancer

    Trial Interventions

    Drug Synonyms Arms
    Poziotinib HM781-36B Poziotinib, oral tablets

    Trial Purpose

    The purpose of this study is to evaluate the efficacy and tolerability of poziotinib in
    patients with HER2-positive metastatic breast cancer who have received at least 2 prior
    HER2-directed treatment regimens.

    Detailed Description

    This is a phase 2, open-label, multicenter study to evaluate the efficacy and tolerability
    of poziotinib in approximately 70 patients with HER2-positive metastatic breast cancer who
    have received at least 2 prior HER2-directed treatment regimens.

    Each treatment cycle will be 21 days in duration. During each 21-day cycle, patients who are
    eligible for participation will receive poziotinib orally once daily for 14 days, followed
    by 7 treatment-free rest days.

    All treated patients will be followed up until disease progression, death, intolerable
    adverse events or up to a maximum of 24 months whichever comes earlier.

    Trial Arms

    Name Type Description Interventions
    Poziotinib, oral tablets Experimental Poziotinib

    Eligibility Criteria

    Inclusion Criteria:

    1. Histopathologically confirmed metastatic breast cancer

    2. Confirmed HER2 overexpression or gene-amplified tumor

    3. At least 2 prior HER2-directed therapy regimens for metastatic breast cancer,
    including trastuzumab and TDM-1.

    4. Patient is at least 18 years of age.

    5. Patient has adequate hematologic, hepatic, and renal functions

    6. At least one measurable lesion

    Exclusion Criteria:

    1. Previous treatment with poziotinib prior to study participation.

    2. Brain metastases that are untreated, symptomatic, or require therapy to control
    symptoms, as well as any history of radiation, surgery, or other therapy, including
    steroids, to control symptoms from brain metastases within 1 month (30 days) of
    enrollment.

    3. Anticancer chemotherapy, biologics, immunotherapy, radiotherapy, or investigational
    treatment within 30 days, except for hormone therapy, which could be given up to 7
    days prior to the first dose of poziotinib.

    4. History of congestive heart failure (CHF) Class III/IV according to the New York
    Heart Association (NYHA) Functional Classification or serious cardiac arrhythmias
    requiring treatment.

    5. Patient has a cardiac ejection fraction <50%

    6. Patient has a history of other malignancies within the last 5 years

    7. Unable to take drugs orally

    8. Patient is pregnant or breast-feeding.

    Minimum Eligible Age: 18 Years

    Maximum Eligible Age: N/A

    Eligible Gender: Both

    Primary Outcome Measures

    Objective Response Rate

    Secondary Outcome Measures

    Adverse Events experience by participants as a measure of toxicity

    Progression Free Survival (PFS)

    Disease Control Rate (DCR)

    Overall Survival (OS)

    Time to Progression (TTP)

    Trial Keywords

    Poziotinib

    Metastatic Breast Cancer

    HER2-positive

    Pan-HER inhibitor