Basket Study of Neratinib in Participants With Solid Tumors Harboring Somatic HER2 or EGFR Exon 18 Mutations
Trial ID or NCT#
NCT01953926
Status
NOT RECRUITING
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
Eligibility Criteria
Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
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.
Investigator(s)
James Ford
Medical oncologist,
Gastrointestinal specialist,
Cancer geneticist
Professor of Medicine (Oncology) and of Genetics and, by courtesy, of Pediatrics
Contact us to find out if this trial is right for you.
Contact
Ivy Lau
650-721-8899
View on ClinicalTrials.gov
