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Breast CancerPhase 2NCT02659514

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

A Phase 2 study testing Poziotinib in people with Breast Cancer, run by Spectrum Pharmaceuticals, Inc at 35 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 90 years
Conditions the study is for
Breast Cancer
What is being tested?
Poziotinib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
67 participants
Where
35 sitesUnited States
Study dates
22 Feb 2016to 11 Mar 2020
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histopathologically confirmed primary breast cancer with metastatic lesions.
  • Confirmed HER2 overexpression or gene-amplified tumor
  • At least two prior HER2-directed therapy regimens for breast cancer, including trastuzumab and trastuzumab emtansine
  • Measurable disease per Response Evaluation Criteria for Solid Tumors version 1.1 (RECIST v1.1)
  • Participant is at least 18, and ≤90 years of age.
  • Adequate hematologic, hepatic, and renal function
  • Eastern Cooperative Oncology Group (ECOG) performance status <= 2

Who cannot join

  • Previous treatment with poziotinib prior to study participation
  • 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.
  • Anticancer chemotherapy, biologics, immunotherapy, cure-intent radiotherapy, or investigational treatment within 15 days, except for hormone therapy, palliative therapy, or supportive therapy.
  • History of congestive heart failure Class III/IV according to the New York Heart Association (NYHA) Functional Classification or serious cardiac arrhythmias requiring treatment.
  • Cardiac ejection fraction <50%
  • History of other malignancies within the last 5 years
  • Participant is pregnant or breast-feeding.
  • Unable to take drugs orally

Trial locations and contacts

35 sites in 1 country.

35 sites in 1 country

United States35 sites

  • Pacific Cancer Medical Center, Inc.

    Anaheim, California, 92801

  • St. Vincent Frontier Cancer Center

    Billings, Montana, 59102

  • Aultman Hospital

    Canton, Ohio, 44710

  • Waverly Hematology Oncology

    Cary, North Carolina, 27518

  • Charleston Cancer Center

    Charleston, South Carolina, 29406

  • Ohio State University

    Columbus, Ohio, 43210

  • North Shore Hematology Oncology Associates

    East Setauket, New York, 11733

  • Marin Cancer Care, Inc

    Greenbrae, California, 94904

  • Hattiesburg Clinic Hematology Oncology

    Hattiesburg, Mississippi, 39401

  • Triple Army Medical Cente

    Honolulu, Hawaii, 96859

  • Oncology Consultants, P.A.

    Houston, Texas, 77030

  • SAMMC - Hem/Onc Clinic

    Houston, Texas, 78234

  • Clearview Cancer Center

    Huntsville, Alabama, 35805

  • Franciscan St. Francis Health

    Indianapolis, Indiana, 46237

  • Providence Regional Cancer System

    Lacey, Washington, 98503

  • Alliance Research Centers

    Laguna Hills, California, 92653

  • PacificShores Medical Group

    Long Beach, California, 90813

  • Texas Oncology-McAllen

    McAllen, Texas, 78503

  • AMPM Research Clinic

    Miami Gardens, Florida, 33169

  • West Virginia University

    Morgantown, West Virginia, 26506

  • Magee Womens Hospital of UPMC

    Pittsburgh, Pennsylvania, 15213

  • FL Cancer Research Institute

    Plantation, Florida, 33324

  • Valley Medical Oncology Consultants

    Pleasanton, California, 94588

  • Hudson Valley Hematology Oncology Associates

    Poughkeepsie, New York, 12601

  • Carolina Blood and Cancer Care Associates PA

    Rock Hill, South Carolina, 29732

  • The University of Texas Health Science Center at San Antonio

    San Antonio, Texas, 78229

  • Medical Oncology Associates, PS

    Spokane, Washington, 99208

  • Washington University

    St Louis, Missouri, 63110

  • Northwest Medical Specialties, PLLC

    Tacoma, Washington, 98405

  • Scott & White Memorial Hospital

    Temple, Texas, 76508

  • Oklahoma Cancer Specialists & Research Institute, LLC

    Tulsa, Oklahoma, 74146

  • The University of Kansas Cancer Center and Medical Pavilion

    Westwood, Kansas, 66205

  • White Plain Hospital

    White Plains, New York, 10601

  • Innovative Clinical Research Institute

    Whittier, California, 90603

  • Bond Clinic, P.A.

    Winter Haven, Florida, 33880

Other trials in United States

About this study

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

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.

Read the 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.

Conditions
Breast Cancer
Being tested
Poziotinib
Keywords
Poziotinib, Metastatic Breast Cancer, HER2-positive, Pan-HER inhibitor
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PoziotinibDrug

    Also called HM781-36B

    8 mg oral tablets, administered QD.

Study groups in NCT02659514
Study groupRoleWhat they receive
Cohort 1: Poziotinib 24 mgExperimentalParticipants 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.
Receives: Drug: Poziotinib
Cohort 2: Poziotinib 16 mgExperimentalParticipants 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.
Receives: Drug: Poziotinib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Objective Response Rate (ORR)

    ORR was defined as the percentage of participants whose best overall response (BOR) was complete response (CR) or partial response (PR) among participants in the Evaluable Population assessed per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1). ORR was based on investigator assessed BOR. Per RECIST v1.1 for target lesions, CR was disappearance of all target tumor lesions (TLs) and all target lymph nodes (LNs) with short axis <10mm. PR was ≥30% decrease in sum of diameters (SOD) from Baseline, and not progressive disease (PD) (≥20% increase in SOD from previous smallest SOD on study, and an absolute increase of ≥5mm).

    Measured: Up to 24 months

Secondary outcomes (6)

  1. Progression Free Survival (PFS)

    PFS was the duration of time (in months) from first administration of study treatment to date of first documented disease progression or death from any cause. PFS of living participants without documented PD was censored at the time of last tumor assessment or the date of first treatment if there was no post-baseline tumor assessment. Per RECIST v1.1 for target lesions, PD was defined as ≥20% increase in SOD from previous smallest SOD on study, and an absolute increase of ≥5mm.

    Measured: Up to 24 Months

  2. Disease Control Rate (DCR)

    DCR was the percentage of participants whose best response was CR, PR or stable disease (SD) among participants in the Evaluable Population assessed per RECIST v1.1. DCR was based on investigator-assessed BOR. Per RECIST v1.1 for target lesions, CR was defined as disappearance of all target TLs and all target LNs with short axis <10mm. PR was ≥30% decrease in sum of diameters (SOD) from Baseline, and not progressive disease (≥20% increase in SOD from previous smallest SOD on study, and an absolute increase of ≥5mm). SD was SOD change neither sufficient for PR nor sufficient for PD.

    Measured: Up to 24 months

  3. Time to Progression (TTP)

    TTP was defined as the time (in months) from first administration of study drug to tumor progression, which excluded death without tumor progression, by the end of study. TTP of participants who died without documented PD was censored at date of death. TTP of living participants without documented PD was censored at the same time as PFS, which was the last tumor assessment or the date of first treatment if there was no post-baseline tumor assessment. Per RECIST v1.1 for target lesions, PD was defined as ≥20% increase in SOD from previous smallest SOD on study, and an absolute increase of ≥5mm.

    Measured: Up to 24 months

  4. Duration of Response (DoR)

    DoR was evaluated only for participants whose BOR was CR or PR and was defined as the time (in months) from the date that response evaluation criteria were first met for CR or PR (whichever status was recorded first) until the first subsequent date that PD or death was documented. DoR of participants without documented PD or death was censored at the time of last tumor assessment. Per RECIST v1.1 for target lesions, CR was defined as disappearance of all target tumor lesions (TLs) and all target lymph nodes (LNs) with short axis <10mm. PR was defined as ≥30% decrease in sum of diameters (SOD) from Baseline, and not PD. PD was defined as ≥20% increase in SOD from previous smallest SOD on study, and an absolute increase of ≥5mm).

    Measured: Up to 24 months

  5. Number of Participants With One or More Treatment-Emergent Adverse Events (TEAEs)

    An AE was defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. TEAEs were AEs that occurred or worsened from the first dose of study treatment until 35 (± 5) days after the last dose of study treatment.

    Measured: 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)

  6. Pharmacokinetic Analysis (Drug Concentration Measurements)

    Measured: 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Jan 2016 (estimated)
  2. Study start22 Feb 2016
  3. Primary completion11 Mar 2020
  4. Study completion11 Mar 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
67 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02659514
Sponsor's protocol ID
SPI-POZ-201
Status last verified
Feb 2022
First submitted
14 Jan 2016
Last updated
11 Mar 2022
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Poziotinib in people with Breast Cancer, run by Spectrum Pharmaceuticals, Inc at 35 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 35 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 Feb 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Response Rate (ORR) (time frame: Up to 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02659514.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2022; AzTrials last refreshed its copy on 8 Nov 2026.

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