NCT02659514

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

A Phase 2 Study of Poziotinib in Patients With HER2-Positive Metastatic Breast Cancer (MBC) Who Have Received Prior HER2 Regimens for MBC

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 67 (actual)
• Sponsor: Spectrum Pharmaceuticals, Inc · Industry
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

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.

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

Interventions

Type	Name	Description
DRUG	Poziotinib	8 mg oral tablets, administered QD.

Timeline

• Start date: 2016-02-22
• Primary completion: 2020-03-11
• Completion: 2020-03-11
• First posted: 2016-01-20
• Last updated: 2022-03-11
• Results posted: 2022-02-10

Locations

35 sites across 1 country: United States

Regulatory

• FDA-regulated drug study