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

NCT02418689 | Completed Phase 2 DMC

• 1 other identifier: NOV120101-203
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 7

Brief 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.

Conditions

Metastatic Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Progression free survival (PFS)

  By 12 months after enrollment of the last subject

Secondary Outcomes (8)

• PFS rate at Week 12

  12 weeks

• Objective Response Rate (ORR)

  By 12 months after enrollment of the last subject

• Disease Control Rate (DCR)

  By 12 months after enrollment of the last subject

• Duration of Disease Control

  By 12 months after enrollment of the last subject

• Overall Survival (OS)

  By 12 months after enrollment of the last subject

Other Outcomes (2)

• Population pharmacokinetics (PK) of NOV120101 (Poziotinib) - Ka, CL(clearance), Vd(volume of distribution)

  4 weeks

• Number of Participants with Adverse Events as a Measure of Safety and Tolerability

  2 years

Study Arms (1)

NOV120101 (Poziotinib)

EXPERIMENTAL

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)

Interventions

NOV120101 (Poziotinib) DRUG

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

Also known as: HM781-36B, Poziotinib

NOV120101 (Poziotinib)

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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%.
• 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

Sponsors & Collaborators

• Hanmi Pharmaceutical Company Limited: lead

Study Sites (7)

National Cancer Center

Goyang-si, Gyeonggi-do, 410-769, South Korea

Location

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 463-707, South Korea

Location

Chungbuk National University Hospital

Cheongju-si, North Chungcheong, 361-711, South Korea

Location

Samsung Medical Center

Gangnam-gu, Seoul, 135-710, South Korea

Location

Seoul National University Hospital

Jongno-gu, Seoul, 110-744, South Korea

Location

Severance Hospital

Seodaemun-gu, Seoul, 120-752, South Korea

Location

Asan Medical Center

Songpa-gu, Seoul, 138-736, South Korea

Location

Related Publications (1)

• 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.

  PMID: 32860168 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

HM781-36B

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 19, 2015
• First Posted: April 16, 2015
• Study Start: April 1, 2015
• Primary Completion: June 1, 2017
• Study Completion: April 1, 2021
• Last Updated: January 20, 2022

Record last verified: 2021-03

Locations

KR (7)