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Basket Study of Neratinib in Participants With Solid Tumors Harboring Somatic HER2 or EGFR Exon 18 Mutations
Not Recruiting
Trial ID: NCT01953926
Purpose
This is an open-label, multicenter, multinational, Phase 2 basket study exploring the efficacy and safety of neratinib as monotherapy or in combination with other therapies in participants with HER (EGFR, HER2) mutation-positive solid tumors.
Official Title
An Open-Label, Phase 2 Basket Study of Neratinib in Patients With Solid Tumors With Somatic Activating HER Mutations
Stanford Investigator(s)
James M Ford
Professor of Medicine (Oncology) and of Genetics and, by courtesy, of Pediatrics
Eligibility
Inclusion Criteria:
* Provide written informed consent
* Histologically confirmed cancers for which no curative therapy exists
* Documented HER2 or EGFR exon 18 mutation
* Participants must agree and commit to use appropriate methods of contraception as outlined in the protocol
* At least one measurable lesion, defined by RECIST v1.1
Exclusion Criteria:
* Participants harboring ineligible somatic HER2 mutations
* Prior treatment with any HER2-directed tyrosine kinase inhibitor (e.g., lapatinib, afatinib, dacomitinib, neratinib) is excluded with the following exception: patients with EGFR exon 18 mutated NSCLC who may have received afatinib, osimertinib, or other pan HER or EGFR TKIs remain eligible
* Participants who are receiving any other anticancer agents
* Symptomatic or unstable brain metastases
* Women who are pregnant or breast-feeding
There are additional inclusion and exclusion criteria. The study center will determine if criteria for participation are met.
Intervention(s):
drug: Neratinib
drug: Fulvestrant
drug: Trastuzumab
drug: Paclitaxel
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Ivy Lau
650-721-8899