This is a Phase 1b, open-label, multicenter study to determine the Maximum Tolerated Dose
(MTD) or Maximum Administered Dose (MAD) of poziotinib when administered with standard
dosing of T-DM1 (3.6 mg/kg IV on Day 1 of each 21-day cycle) in women with advanced or
metastatic HER2+ breast cancer. The poziotinib dose identified in Part 1 of the study
will be used in combination with standard dose of T-DM1 in Part 2 of the study to confirm
the poziotinib dose and evaluate the preliminary efficacy of the combination therapy.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03429101.
In Part 1, the dose of poziotinib, in combination with the standard dose of T-DM1 (3.6
mg/kg IV) on Day 1 of each cycle will be determined using a "3+3" design with up to 3
dose levels tested beginning with 8 mg/day.
Poziotinib dose escalation/de-escalation for the next dose cohort will proceed based on
the occurrence of dose-limiting toxicities (DLTs) during Cycle 1 of the dose cohort.
Patients in the dose cohort, if not discontinued, will continue treatment until
discontinuation.
In Part 2 of the study, approximately 10 patients will be treated at the MTD/MAD to
confirm dose for safety of the combination and to evaluate preliminary efficacy.
Treatment for all patients will continue until disease progression, unacceptable
toxicity, or continuation of study treatment is not in the best interest of the patient.
The Screening period (Day -30 to Day -1) will last up to 30 days prior to Cycle 1, Day 1.
During each 21-day cycle, eligible patients will receive poziotinib at the assigned dose,
orally, once daily. T-DM1 3.6 mg/kg IV will be administered on Day 1 of each treatment
cycle.
All treated patients will be followed for response until disease progression or the start
of new treatment and then for survival (3 year study duration).
Lead OrganizationSpectrum Pharmaceuticals Inc
