A Phase 1 interventional study of Poziotinib and T-DM1 in Breast Cancer, sponsored by Spectrum Pharmaceuticals, Inc. Terminated at 2 sites in United States. Open to female participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2021-01-15.
Sponsored by Spectrum Pharmaceuticals, Inc · Phase 1, Interventional, and Treatment
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.
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).
Exclusion Criteria:
* Part 1: Dose Finding The MTD/MAD of poziotinib in combination with the standard dose of T-DM1 will be determined 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 to further evaluate the combination at the MTD or the MAD.
Drug: Poziotinib · Drug: T-DM1
Poziotinib is a tablet for oral administration.
T-DM1 (ado-trastuzumab emtansine) is a HER2-targeted therapy for I.V. administration.
Also known as: ado-trastuzumab emtansine
Objective Response Rate (ORR)
Evaluate the Objective Response Rate (ORR) in patients treated with daily poziotinib in combination with T-DM1 (every 3 weeks) in women with advanced or metastatic HER2 positive breast cancer.
Time frame: 3 Years
Disease Control Rate (DCR)
Evaluate the Disease Control Rate (DCR) at 9, 18, and 27 weeks in patients treated at the MTD/MAD.
Time frame: 27 weeks
Progression-free Survival (PFS)
Evaluate Progression-free Survival (PFS) in patients treated with MTD/MAD.
Time frame: 3 years
This study is terminated, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.
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Spectrum Pharmaceuticals, Inc