Poziotinib in Patients With HER2+ Recurrent Stage IV BC Who Have Received at Least 2 Prior HER2-directed Regimens

January 5, 2022 updated by: Hanmi Pharmaceutical Company Limited

A Prospective, Open-label, Single-arm, Multi-Center, Phase II Trial of NOV120101 in Patients With HER2-overexpressed Recurrent Stage IV Breast Cancer Who Have Received at Least 2 Prior HER2-directed Regimens

The purpose of this study is to evaluate the efficacy and safety of novel pan-HER inhibitor, NOV120101 (Poziotinib), in HER2-overexpressed recurrent stage IV breast cancer patients who received at least 2 prior HER2-directed regimens.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

To evaluate the efficacy of NOV120101 (Poziotinib) as a therapeutic agent for HER2-overexpressed recurrent stage IV breast cancer, patients who have received at least two prior HER2-directed regimens will be enrolled in this study. Subjects will receive NOV120101 (Poziotinib) 12 mg PO once daily for 2 weeks followed by 1-week drug-free intervals between cycles until disease progression or unacceptable toxicity development. Progression Free Survival (PFS) will be analyzed as the primary endpoint in this trial. Secondary endpoints including PFS rate at 12 weeks, ORR, DCR, OS and TTP will also be analyzed.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
106

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Chungcheongbuk-do
      • Cheongju-si, Chungcheongbuk-do, Korea, Republic of, 361-711
        • Chungbuk National University Hospital
    • Gyeonggi-do
      • Goyang-si, Gyeonggi-do, Korea, Republic of, 410-769
        • National Cancer Center
      • Seongnam-si, Gyeonggi-do, Korea, Republic of, 463-707
        • Seoul National University Bundang Hospital
    • Seoul
      • Gangnam-gu, Seoul, Korea, Republic of, 135-710
        • Samsung Medical Center
      • Jongno-gu, Seoul, Korea, Republic of, 110-744
        • Seoul National University Hospital
      • Seodaemun-gu, Seoul, Korea, Republic of, 120-752
        • Severance Hospital
      • Songpa-gu, Seoul, Korea, Republic of, 138-736
        • Asan Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Who give agreement to the collection of tumor tissue specimen suitable for biomarker research
  2. ECOG performance status ≤ 2

  3. Who received following treatments as Taxane-based chemotherapy and at least two HER2-targeted* therapy including Trastuzumab.

    * lapatinib, T-DM1 (trastuzumab emtansine), pertuzumab

  4. Adequate hematological, hepatic and renal functions

Exclusion Criteria:

  1. Who received NOV120101 prior to participation in this study
  2. Patients expected to exhibit hypersensitivity to IP or its components
  3. Any other concurrent chemotherapies
  4. Concurrent or prior radiotherapy within 4 weeks before study participation. However, patients with additional lesions other than the major lesion who completed and recovered from all treatment-related toxicities after radiotherapy in a limited area as a palliative therapy are allowed to participate in the study
  5. History of symptomatic or unstable angina and congestive heart failure; arrhythmia requiring medications; or clinically significant myocardial infarction or other cardiac diseases within 6 months before study participation for which any related-significant risks are expected
  6. Patients whose left ventricle ejection fraction (LVEF) is below the institutional lower limit of normal. However, if no lower limit of normal is defined in the site, the lower limit or normal is 50%.
  7. Concurrent active hepatic or biliary disease (with exception of Gilbert's syndrome, asymptomatic gallstones, liver metastases or stable chronic liver diseases)
  8. History or concurrent ongoing/active infection, or uncontrolled diseases including, but not limited to, psychiatric illness/social situations which may limit the compliance with study procedures
  9. Prior chemo-, immuno-, or surgical therapy within 3 weeks, or hormone therapy within 1 week before IP administration
  10. History of primary malignancies other than breast cancer.
  11. Patients with central nervous system (CNS) metastases.
  12. Patients receiving or expected to receive bisphosphonate for prophylactic use without any bone-related diseases during the trial, for the exception of the treatment for bone metastases or osteoporosis initiated prior the IP administration.
  13. Clinically significant or recent acute gastrointestinal disorders with diarrhea as a major symptom
  14. Who are unstable or with unresolved severe adverse event(s)
  15. Pregnancy or breast-feeding
  16. Women of childbearing potential or men who are unwilling to use adequate contraception or be abstinent during the trial and for at least 2 months after the end of treatment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: NOV120101 (Poziotinib)
Single arm study with NOV120101(poziotinib) 12 mg PO once daily for 2 weeks followed by a 1-week drug-free interval
Drug: NOV120101 (Poziotinib)
NOV120101 (Poziotinib) 12 mg PO once daily for 2 weeks followed by a 1-week drug-free interval between cycles until disease progression or unacceptable toxicity development
Other Names:
  • Poziotinib
  • HM781-36B

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Progression free survival (PFS)
Time Frame: By 12 months after enrollment of the last subject
By 12 months after enrollment of the last subject

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
PFS rate at Week 12
Time Frame: 12 weeks
12 weeks
Objective Response Rate (ORR)
Time Frame: By 12 months after enrollment of the last subject
the proportion of patients with complete response (CR) and/or partial response (PR)
By 12 months after enrollment of the last subject
Disease Control Rate (DCR)
Time Frame: By 12 months after enrollment of the last subject
the proportion of patients with CR, PR and/or stable disease (SD)] [Safety Issue?
By 12 months after enrollment of the last subject
Duration of Disease Control
Time Frame: By 12 months after enrollment of the last subject
By 12 months after enrollment of the last subject
Overall Survival (OS)
Time Frame: By 12 months after enrollment of the last subject
By 12 months after enrollment of the last subject
Time To Progression (TTP)
Time Frame: By 12 months after enrollment of the last subject
By 12 months after enrollment of the last subject
Time to objective response
Time Frame: By 12 months after enrollment of the last subject
By 12 months after enrollment of the last subject
Duration of objective response
Time Frame: By 12 months after enrollment of the last subject
By 12 months after enrollment of the last subject

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Time Frame
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time Frame: 2 years
2 years
Population pharmacokinetics (PK) of NOV120101 (Poziotinib) - Ka, CL(clearance), Vd(volume of distribution)
Time Frame: 4 weeks
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hanmi Pharmaceutical Company Limited

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 19, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 13, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 16, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 20, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 5, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NOV120101-203

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Metastatic Breast Cancer

Clinical Trials on NOV120101 (Poziotinib)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings