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

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ClinicalTrials.gov Identifier: NCT02659514
Recruitment Status : Active, not recruiting
First Posted : January 20, 2016
Last Update Posted : December 6, 2018
Sponsor:
Information provided by (Responsible Party):
Spectrum Pharmaceuticals, Inc

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: Poziotinib Phase 2

Detailed Description:

This is a phase 2, open-label, multicenter study 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.

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.

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 75 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : February 2016
Estimated Primary Completion Date : October 2020
Estimated Study Completion Date : April 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: Poziotinib, oral tablets Drug: Poziotinib
Supplied as oral tablets, administered daily for each 21 days cycle.
Other Name: HM781-36B




Primary Outcome Measures :
  1. Objective Response Rate [ Time Frame: 24 month ]
    defined as the best response [Complete Response (CR) + Partial Response (PR)] recorded from the start of the study until the end of study in patients who received at least 1 dose of poziotinib.


Secondary Outcome Measures :
  1. Progression Free Survival (PFS) [ Time Frame: 24 Months ]
  2. Disease Control Rate (DCR) [ Time Frame: 24-Months ]
  3. Time to Progression (TTP) [ Time Frame: 24 Months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Histopathologically confirmed primary breast cancer with metastatic lesions.
  2. Confirmed HER2 overexpression or gene-amplified tumor
  3. At least two prior HER2-directed therapy regimens for breast cancer, including trastuzumab and trastuzumab emtansine (TDM-1, KADCYLA®)
  4. Patient is at least 18, and ≤90 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 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 15 days of enrollment.
  3. Anticancer chemotherapy, biologics, immunotherapy, cure-intent radiotherapy, or investigational treatment within 15 days, except for hormone therapy, palliative therapy, or supportive therapy.
  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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02659514


Locations
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United States, California
Jennifer Lucas, MD. Marin Cancer Care, Inc
Greenbrae, California, United States, 94904
United States, New York
Jeffrey Vacirca, MD North Shore Hematology Oncology Associates
East Setauket, New York, United States, 11733
Sponsors and Collaborators
Spectrum Pharmaceuticals, Inc

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Responsible Party: Spectrum Pharmaceuticals, Inc
ClinicalTrials.gov Identifier: NCT02659514     History of Changes
Other Study ID Numbers: SPI-POZ-201
First Posted: January 20, 2016    Key Record Dates
Last Update Posted: December 6, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Spectrum Pharmaceuticals, Inc:
Poziotinib
Metastatic Breast Cancer
HER2-positive
Pan-HER inhibitor
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases