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Poziotinib in Advanced Malignancies with EGFR or HER2 Mutations
NCT04172597Phase 2
Key facts
- Status
- Terminated
- Start
- Dec 2019
- Primary completion
- Mar 2022
- Countries
- 1
- Modality
- Small Molecules
- Drugs
- poziotinib
- Conditions
- breast cancercolorectal cancer (CRC)glioblastoma multiforme (GBM)solid tumor
01
Overview
Phase 2, open-label trial of poziotinib in breast cancer, colorectal cancer (CRC), glioblastoma multiforme (GBM) and 1 more (5 arms), sponsored by Spectrum Pharmaceuticals, Inc. Primary endpoint: Objective Response Rate up to 168 days. Started Dec 2019; status: terminated.
02
Design
5 arms- Study design
- Non-randomizedOpen-label
Breast Cancer (HER2 mut)
HER2+ or HER2- BC with HER2 activating mutation. Poziotinib 8 mg BID.
Colorectal Cancer (HER2 mut)
CRC with HER2 activating mutation. Poziotinib 8 mg BID.
Solid Tumor (HER2 mut)
Other solid tumors with HER2 activating mutation. Poziotinib 8 mg BID.
GBM (EGFR mut)
GBM with EGFR activating mutation. Poziotinib 8 mg BID.
Solid Tumor (EGFR mut)
Other solid tumors with EGFR activating mutation. Poziotinib 8 mg BID.
03
Who it enrols
Patients aged 18+ with advanced solid tumors (BC, CRC, GBM, others) harboring specific EGFR or HER2 activating mutations (often exon 20) who have exhausted standard therapies.
04
Endpoints
Primary
Objective Response Rate
Secondary
Duration of Response
Disease Control Rate
Percentage of Participants With Adverse Events
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