A Study of Poziotinib in Combination With T-DM1 in HER2-Positive Breast Cancer
Last updated on July 2021Recruitment
- Recruitment Status
- Terminated
- Estimated Enrollment
- 25
Summary
- Conditions
- Breast Cancer
- Type
- Interventional
- Phase
- Phase 1
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentIntervention Model Description: Part 1: Dose Finding To determine the MTD/MAD of poziotinib in combination with the standard dose of T-DM1 by using a "3+3" design. At least 3 patients may be enrolled in each cohort before a decision is made to proceed to the next cohort. Part 2: MTD/MAD Expansion An additional 10 patients will be treated at the dose identified during Part 1 of the study to further evaluate the safety and efficacy. Masking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 90 years
- Gender
- Only males
Description
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 base...
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).
Tracking Information
- NCT #
- NCT03429101
- Collaborators
- Not Provided
- Investigators
- Not Provided