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This is a Phase 2, open-label, multicenter study whose principal objectives are to evaluate the efficacy and safety/tolerability of poziotinib in five cohorts of 30 previously-treated patients each.
Full description
The Screening period (Day -30 to Day 1) begins 30 days prior to poziotinib treatment on Day 1 of Cycle 1. Patients must meet all Inclusion/Exclusion Criteria and provide informed written consent prior to study procedures.
The duration of each treatment cycle is 28 days. There will be five patient cohorts. Eligible patients will be enrolled into cohorts concurrently based on EGFR or HER2 exon 20 mutation status.
All patients will be treated daily for up to 24 months unless there is disease progression, death, intolerable adverse events (AEs), or another protocol-specified reason for patient withdrawal. After treatment discontinuation, patients will be contacted every 3 months for up to 2 years after the first dose of poziotinib to assess survival.
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Inclusion and exclusion criteria
Key Inclusion Criteria:
Patients must be at least 18 years old.
Patients must have histologic or cytologic evidence of a malignant solid cancer that is either advanced or metastatic there must be no available therapy known to confer a reasonable likelihood of clinical benefit.
Patients with BC must have a HER2 activating mutation determined by next-generation sequencing (NGS) performed on either tumor or plasma samples and:
Patients with microsatellite instability-high (MSI-H) CRC must have had appropriate checkpoint inhibitor-based therapy.
Patient's tumor must be positive for an EGFR or HER2 mutation based on DNA testing of either tumor tissue or plasma samples. Patients with documented EGFR or HER2 mutations may be identified by local testing from participating sites using next generation sequencing tests. Patient has a solid tumor with at least one of the listed activating mutations:
Patients must have measurable disease.
Patients with central nervous system (CNS) metastases must have stable CNS disease and no evidence of growth on imaging for at least 4 weeks following radiation or other locoregional ablative therapy. CNS symptoms must be stable with no requirement for anti-seizure medications and/or > 2 mg/day dexamethasone equivalent, except for patients with GBM (Cohort 4), in whom anti-seizure medications and/or up to 4 mg/day dexamethasone equivalent is allowed.
Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status ≤ -1.
Patients must have adequate hematopoietic, renal, and liver functions.
Exclusion Criteria:
Primary purpose
Allocation
Interventional model
Masking
1 participants in 5 patient groups
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Data sourced from clinicaltrials.gov
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