A Study of Poziotinib in Combination With T-DM1 in HER2-Positive Breast Cancer
Stopped early · Phase 1
Conditions studied: Breast Cancer
In brief
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.
Key facts
- Study ID
- NCT03429101
- Run by
- Spectrum Pharmaceuticals, Inc
- People needed
- 6
- Starts
- 2018-07-13
- Expected to finish
- 2019-04-17
- Last updated by the study team
- 2021-01-15
Who can join
Age: 18 and older, up to 90. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- Patient must be female, at least 18 years of age, but not older than 90 years, with advanced or metastatic HER2+ breast cancer and a life expectancy of more than 6 months
- Patient must have confirmed HER2 overexpression or gene-amplified tumor via immunohistochemistry [IHC] with IHC 3+ or IHC 2+ with confirmatory fluorescence in situ hybridization [FISH]+ or [ISH]+
- Patients must have had at least 1 line of anti-HER2 directed therapy either in the metastatic or early-stage disease setting
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
You may not qualify if…
- Patient has had previous treatment with poziotinib.
- Patient has received anticancer chemotherapy, TKIs, biologics, immunotherapy, radiotherapy, or investigational treatment within 15 days. (There is no washout for hormonal therapy for breast cancer).
- Patient has a life expectancy less than 3 years due to other malignancies.
- Patient is pregnant or breast-feeding.
Where it is running
- Pacific Cancer Medical Center, Inc. — Anaheim, California, United States
- Los Angeles Hematology Oncology Medical Group — Glendale, California, United States
Full record on ClinicalTrials.gov
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