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

Spectrum Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Breast Cancer

Treatments: Drug: Poziotinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT02659514

SPI-POZ-201

Details and patient eligibility

About

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.

Full 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.

Enrollment: 67 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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67 participants in 2 patient groups

Cohort 1: Poziotinib 24 mg

Experimental group

Description:

Participants 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.

Treatment:

Drug: Poziotinib

Cohort 2: Poziotinib 16 mg

Experimental group

Description:

Participants 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.

Treatment:

Drug: Poziotinib