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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02659514
Recruitment Status : Active, not recruiting
First Posted : January 20, 2016
Last Update Posted : August 4, 2020
Sponsor:
Information provided by (Responsible Party):
Spectrum Pharmaceuticals, Inc

Tracking Information
First Submitted Date  ICMJE January 14, 2016
First Posted Date  ICMJE January 20, 2016
Last Update Posted Date August 4, 2020
Actual Study Start Date  ICMJE February 1, 2016
Estimated Primary Completion Date October 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 4, 2018)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: January 15, 2016)
Objective Response Rate [ Time Frame: 24 month ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 4, 2018)
  • Progression Free Survival (PFS) [ Time Frame: 24 Months ]
  • Disease Control Rate (DCR) [ Time Frame: 24-Months ]
  • Time to Progression (TTP) [ Time Frame: 24 Months ]
Original Secondary Outcome Measures  ICMJE
 (submitted: January 15, 2016)
  • Safety and Tolerability [ Time Frame: 24 Months ]
    Incidence of adverse events (AEs) and serious adverse events (SAEs) as assessed by CTCAE v4.03.
  • Progression Free Survival (PFS) [ Time Frame: 24 Months ]
  • Disease Control Rate (DCR) [ Time Frame: 24-Months ]
  • Overall Survival (OS) [ Time Frame: 24 Months ]
  • Time to Progression (TTP) [ Time Frame: 24 Months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of Poziotinib in Patients With HER2-Positive Metastatic Breast Cancer
Official Title  ICMJE A Phase 2 Study of Poziotinib in Patients With HER2-Positive Metastatic Breast Cancer (MBC) Who Have Received Prior HER2 Regimens for MBC
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Breast Cancer
Intervention  ICMJE Drug: Poziotinib
Supplied as oral tablets, administered daily for each 21 days cycle.
Other Name: HM781-36B
Study Arms  ICMJE Experimental: Poziotinib, oral tablets
Intervention: Drug: Poziotinib
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: July 31, 2020)
67
Original Estimated Enrollment  ICMJE
 (submitted: January 15, 2016)
70
Estimated Study Completion Date  ICMJE April 2021
Estimated Primary Completion Date October 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02659514
Other Study ID Numbers  ICMJE SPI-POZ-201
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Spectrum Pharmaceuticals, Inc
Study Sponsor  ICMJE Spectrum Pharmaceuticals, Inc
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Shanta Chawla, MD Spectrum Pharmaceuticals, Inc
PRS Account Spectrum Pharmaceuticals, Inc
Verification Date July 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP