Study of Poziotinib in Participants With HER2-Positive Metastatic Breast Cancer
NCT ID: NCT02659514
Last Updated: 2022-03-11
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
67 participants
INTERVENTIONAL
2016-02-22
2020-03-11
Brief Summary
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Detailed Description
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Each treatment cycle will be 21 days in duration. During each 21-day cycle, participants who are eligible for participation will receive poziotinib orally once daily.
All treated participants will be followed up until disease progression, death, intolerable adverse events or up to a maximum of 24 months whichever comes earlier.
Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Cohort 1: Poziotinib 24 mg
Participants received poziotinib 24 milligrams (mg), administered as three 8 mg tablets, orally, once daily (QD) on an intermittent dosing schedule of 14 days on treatment followed by 7 days off treatment, in a 21-day cycle until disease progression, death, intolerable adverse events (AEs) or for up to a maximum of 24 months, whichever occurs first.
Poziotinib
8 mg oral tablets, administered QD.
Cohort 2: Poziotinib 16 mg
Participants received poziotinib 16 mg, administered as two 8 mg tablets, orally, QD, on a continuous dosing schedule in a 21-day cycle until disease progression, death, intolerable AEs or for up to a maximum of 24 months, whichever occurs first.
Poziotinib
8 mg oral tablets, administered QD.
Interventions
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Poziotinib
8 mg oral tablets, administered QD.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
4. Measurable disease per Response Evaluation Criteria for Solid Tumors version 1.1 (RECIST v1.1)
5. Participant is at least 18, and ≤90 years of age.
6. Adequate hematologic, hepatic, and renal function
7. Eastern Cooperative Oncology Group (ECOG) performance status \<= 2
Exclusion Criteria
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 Class III/IV according to the New York Heart Association (NYHA) Functional Classification or serious cardiac arrhythmias requiring treatment.
5. Cardiac ejection fraction \<50%
6. History of other malignancies within the last 5 years
7. Participant is pregnant or breast-feeding.
8. Unable to take drugs orally
18 Years
90 Years
ALL
No
Sponsors
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Spectrum Pharmaceuticals, Inc
INDUSTRY
Responsible Party
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Principal Investigators
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Shanta Chawla, MD
Role: STUDY_DIRECTOR
Spectrum Pharmaceuticals, Inc
Locations
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Clearview Cancer Center
Huntsville, Alabama, United States
Pacific Cancer Medical Center, Inc.
Anaheim, California, United States
Marin Cancer Care, Inc
Greenbrae, California, United States
Alliance Research Centers
Laguna Hills, California, United States
PacificShores Medical Group
Long Beach, California, United States
Valley Medical Oncology Consultants
Pleasanton, California, United States
Innovative Clinical Research Institute
Whittier, California, United States
AMPM Research Clinic
Miami Gardens, Florida, United States
FL Cancer Research Institute
Plantation, Florida, United States
Bond Clinic, P.A.
Winter Haven, Florida, United States
Triple Army Medical Cente
Honolulu, Hawaii, United States
Franciscan St. Francis Health
Indianapolis, Indiana, United States
The University of Kansas Cancer Center and Medical Pavilion
Westwood, Kansas, United States
Hattiesburg Clinic Hematology Oncology
Hattiesburg, Mississippi, United States
Washington University
St Louis, Missouri, United States
St. Vincent Frontier Cancer Center
Billings, Montana, United States
North Shore Hematology Oncology Associates
East Setauket, New York, United States
Hudson Valley Hematology Oncology Associates
Poughkeepsie, New York, United States
White Plain Hospital
White Plains, New York, United States
Waverly Hematology Oncology
Cary, North Carolina, United States
Aultman Hospital
Canton, Ohio, United States
Ohio State University
Columbus, Ohio, United States
Oklahoma Cancer Specialists & Research Institute, LLC
Tulsa, Oklahoma, United States
Magee Womens Hospital of UPMC
Pittsburgh, Pennsylvania, United States
Charleston Cancer Center
Charleston, South Carolina, United States
Carolina Blood and Cancer Care Associates PA
Rock Hill, South Carolina, United States
Oncology Consultants, P.A.
Houston, Texas, United States
SAMMC - Hem/Onc Clinic
Houston, Texas, United States
Texas Oncology-McAllen
McAllen, Texas, United States
The University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States
Scott & White Memorial Hospital
Temple, Texas, United States
Providence Regional Cancer System
Lacey, Washington, United States
Medical Oncology Associates, PS
Spokane, Washington, United States
Northwest Medical Specialties, PLLC
Tacoma, Washington, United States
West Virginia University
Morgantown, West Virginia, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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SPI-POZ-201
Identifier Type: -
Identifier Source: org_study_id
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