Status:
TERMINATED
A Study of Poziotinib in Combination With T-DM1 in HER2-Positive Breast Cancer
Lead Sponsor:
Spectrum Pharmaceuticals, Inc
Conditions:
Breast Cancer
Eligibility:
FEMALE
18-90 years
Phase:
PHASE1
Brief Summary
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...
Detailed 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 beginnin...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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.
Key Trial Info
Start Date :
July 13 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 17 2019
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT03429101
Start Date
July 13 2018
End Date
April 17 2019
Last Update
January 15 2021
Active Locations (2)
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1
Pacific Cancer Medical Center, Inc.
Anaheim, California, United States, 92801
2
Los Angeles Hematology Oncology Medical Group
Glendale, California, United States, 91204