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Metastatic Breast CancerPhase 2NCT02418689

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

A Phase 2 study testing NOV120101 (Poziotinib) in people with Metastatic Breast Cancer, run by Hanmi Pharmaceutical Company Limited at 7 sites in South Korea.

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 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. Read more about this study

Who is it for?
Ages 19 years and older
Conditions the study is for
Metastatic Breast Cancer
What is being tested?
NOV120101 (Poziotinib)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
106 participants
Where
7 sitesSouth Korea
Study dates
Apr 2015to Apr 2021
Phase
Phase 2
Are there results?
None posted in the registry

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 19 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Who give agreement to the collection of tumor tissue specimen suitable for biomarker research
  • ECOG performance status ≤ 2
  • Who received following treatments as Taxane-based chemotherapy and at least two HER2-targeted* therapy including Trastuzumab.
  • lapatinib, T-DM1 (trastuzumab emtansine), pertuzumab
  • Adequate hematological, hepatic and renal functions

Who cannot join

  • Who received NOV120101 prior to participation in this study
  • Patients expected to exhibit hypersensitivity to IP or its components
  • Any other concurrent chemotherapies
  • 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
  • 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
  • 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%.
Show all 16Show fewer
  • Concurrent active hepatic or biliary disease (with exception of Gilbert's syndrome, asymptomatic gallstones, liver metastases or stable chronic liver diseases)
  • 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
  • Prior chemo-, immuno-, or surgical therapy within 3 weeks, or hormone therapy within 1 week before IP administration
  • History of primary malignancies other than breast cancer.
  • Patients with central nervous system (CNS) metastases.
  • 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.
  • Clinically significant or recent acute gastrointestinal disorders with diarrhea as a major symptom
  • Who are unstable or with unresolved severe adverse event(s)
  • Pregnancy or breast-feeding
  • 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

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

South Korea7 sites

  • Chungbuk National University Hospital

    Cheongju-si, North Chungcheong, 361-711

  • Samsung Medical Center

    Gangnam-gu, Seoul, 135-710

  • National Cancer Center

    Goyang-si, Gyeonggi-do, 410-769

  • Seoul National University Hospital

    Jongno-gu, Seoul, 110-744

  • Severance Hospital

    Seodaemun-gu, Seoul, 120-752

  • Seoul National University Bundang Hospital

    Seongnam-si, Gyeonggi-do, 463-707

  • Asan Medical Center

    Songpa-gu, Seoul, 138-736

Other trials in South Korea

About this study

Official title: 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.

Read the 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.

Being tested
NOV120101 (Poziotinib)
Medical subject headings
Breast Neoplasms

What participants receive

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

  • NOV120101 (Poziotinib)Drug

    Also called HM781-36B, 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

Study groups in NCT02418689
Study groupRoleWhat they receive
NOV120101 (Poziotinib)ExperimentalSingle arm study with NOV120101(poziotinib) 12 mg PO once daily for 2 weeks followed by a 1-week drug-free interval
Receives: Drug: NOV120101 (Poziotinib)

What is being measured

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

  1. Progression free survival (PFS)

    Measured: By 12 months after enrollment of the last subject

Secondary outcomes (8)

  1. PFS rate at Week 12

    Measured: 12 weeks

  2. Objective Response Rate (ORR)

    the proportion of patients with complete response (CR) and/or partial response (PR)

    Measured: By 12 months after enrollment of the last subject

  3. Disease Control Rate (DCR)

    the proportion of patients with CR, PR and/or stable disease (SD)] [Safety Issue?

    Measured: By 12 months after enrollment of the last subject

  4. Duration of Disease Control

    Measured: By 12 months after enrollment of the last subject

  5. Overall Survival (OS)

    Measured: By 12 months after enrollment of the last subject

  6. Time To Progression (TTP)

    Measured: By 12 months after enrollment of the last subject

  7. Time to objective response

    Measured: By 12 months after enrollment of the last subject

  8. Duration of objective response

    Measured: By 12 months after enrollment of the last subject

Timeline

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

  1. First posted16 Apr 2015 (estimated)
  2. Study startApr 2015
  3. Primary completionJun 2017
  4. Study completionApr 2021

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
106 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02418689
Sponsor's protocol ID
NOV120101-203
Status last verified
Mar 2021
First submitted
19 Jan 2015
Last updated
20 Jan 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Kim JY, Park K, Im SA, Jung KH, Sohn J, Lee KS, Kim JH, Yang Y, Park YH. Clinical implications of HER2 mRNA expression and intrinsic subtype in refractory HER2-positive metastatic breast cancer treated with pan-HER inhibitor, poziotinib. Breast Cancer Res Treat. 2020 Dec;184(3):743-753. doi: 10.1007/s10549-020-05891-0. Epub 2020 Aug 28.

    PubMed 32860168

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing NOV120101 (Poziotinib) in people with Metastatic Breast Cancer, run by Hanmi Pharmaceutical Company Limited at 7 sites in South Korea.

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 5 inclusion and 16 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 20 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in South Korea. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Progression free survival (PFS) (time frame: By 12 months after enrollment of the last subject). 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 NCT02418689, which also lists 1 linked publication.

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 20 Jan 2022.

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