Clinical trial NCT02659514: Study of Poziotinib in Participants 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Breast Cancer
Keywords: Poziotinib
Metastatic Breast Cancer
HER2-positive
Pan-HER inhibitor
Lead sponsor: Spectrum Pharmaceuticals, Inc
Sponsor class: INDUSTRY
First posted: 2016-01-20
Enrollment: 67
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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 participants with human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer who have received at least two 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 participants with HER2-positive metastatic breast cancer who have received at least two prior HER2-directed treatment regimens.

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.

Eligibility 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
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:

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 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

Primary outcomes:
measure: Objective Response Rate (ORR)
timeFrame: Up to 24 months
Secondary outcomes:
measure: Progression Free Survival (PFS)
timeFrame: Up to 24 Months
measure: Disease Control Rate (DCR)
timeFrame: Up to 24 months
measure: Time to Progression (TTP)
timeFrame: Up to 24 months
measure: Duration of Response (DoR)
timeFrame: Up to 24 months
measure: Number of Participants With One or More Treatment-Emergent Adverse Events (TEAEs)
timeFrame: From the first dose of study drug administration until 35 (± 5) days after the last dose of study drug administration (Up to approximately 25 months)
measure: Pharmacokinetic Analysis (Drug Concentration Measurements)
timeFrame: For Cohort 1: Pre-dose and 1 and 2 hours post-dose on Day 1 of Cycles 1, 2, and 3, and pre-dose on Day 14 of Cycle 1 For Cohort 2: Day 1 of Cycle 1 pre-dose and 30 minutes, 1,1.5,2,3, 4, 6, and 24 hours post-dose of Day 1 of Cycle 1
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: Clearview Cancer Center
state: Alabama
city: Anaheim
country: United States
facility: Pacific Cancer Medical Center, Inc.
state: California
city: Greenbrae
country: United States
facility: Marin Cancer Care, Inc
state: California
city: Laguna Hills
country: United States
facility: Alliance Research Centers
state: California
city: Long Beach
country: United States
facility: PacificShores Medical Group
state: California
city: Pleasanton
country: United States
facility: Valley Medical Oncology Consultants
state: California
city: Whittier
country: United States
facility: Innovative Clinical Research Institute
state: California
city: Miami Gardens
country: United States
facility: AMPM Research Clinic
state: Florida
city: Plantation
country: United States
facility: FL Cancer Research Institute
state: Florida
city: Winter Haven
country: United States
facility: Bond Clinic, P.A.
state: Florida
city: Honolulu
country: United States
facility: Triple Army Medical Cente
state: Hawaii
city: Indianapolis
country: United States
facility: Franciscan St. Francis Health
state: Indiana
city: Westwood
country: United States
facility: The University of Kansas Cancer Center and Medical Pavilion
state: Kansas
city: Hattiesburg
country: United States
facility: Hattiesburg Clinic Hematology Oncology
state: Mississippi
city: Saint Louis
country: United States
facility: Washington University
state: Missouri
city: Billings
country: United States
facility: St. Vincent Frontier Cancer Center
state: Montana
city: East Setauket
country: United States
facility: North Shore Hematology Oncology Associates
state: New York
city: Poughkeepsie
country: United States
facility: Hudson Valley Hematology Oncology Associates
state: New York
city: White Plains
country: United States
facility: White Plain Hospital
state: New York
city: Cary
country: United States
facility: Waverly Hematology Oncology
state: North Carolina
city: Canton
country: United States
facility: Aultman Hospital
state: Ohio
city: Columbus
country: United States
facility: Ohio State University
state: Ohio
city: Tulsa
country: United States
facility: Oklahoma Cancer Specialists & Research Institute, LLC
state: Oklahoma
city: Pittsburgh
country: United States
facility: Magee Womens Hospital of UPMC
state: Pennsylvania
city: Charleston
country: United States
facility: Charleston Cancer Center
state: South Carolina
city: Rock Hill
country: United States
facility: Carolina Blood and Cancer Care Associates PA
state: South Carolina
city: Houston
country: United States
facility: Oncology Consultants, P.A.
state: Texas
city: Houston
country: United States
facility: SAMMC - Hem/Onc Clinic
state: Texas
city: McAllen
country: United States
facility: Texas Oncology-McAllen
state: Texas
city: San Antonio
country: United States
facility: The University of Texas Health Science Center at San Antonio
state: Texas
city: Temple
country: United States
facility: Scott & White Memorial Hospital
state: Texas
city: Lacey
country: United States
facility: Providence Regional Cancer System
state: Washington
city: Spokane
country: United States
facility: Medical Oncology Associates, PS
state: Washington
city: Tacoma
country: United States
facility: Northwest Medical Specialties, PLLC
state: Washington
city: Morgantown
country: United States
facility: West Virginia University
state: West Virginia
Study officials:
affiliation: Spectrum Pharmaceuticals, Inc
name: Shanta Chawla, MD
role: STUDY_DIRECTOR
References: