Basket Study of Neratinib in Participants With Solid Tumors Harboring Somatic HER2 or EGFR Exon 18 Mutations
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.
Checked against the public recordLast updated Mar 12, 2024 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 2
- Sponsor
- Puma Biotechnology, Inc.
- Interventions being studied
- Drug: Neratinib; Drug: Fulvestrant; Drug: Trastuzumab; Drug: Paclitaxel
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
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.
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- University of Alabama at BirminghamBirmingham, Alabama
- Mayo Clinic ArizonaPhoenix, Arizona
- City of HopeDuarte, California
- University of California, San DiegoLa Jolla, California
- University of Southern CaliforniaLos Angeles, California
- University of California, Los AngelesLos Angeles, California
- Stanford Cancer CenterPalo Alto, California
- UCSF Helen Diller Family Comprehensive Cancer CenterSan Francisco, California
- Kaiser Permanente NoCal (STRATA)Vallejo, California
- Mayo Clinic FloridaJacksonville, Florida
- University of MiamiMiami, Florida
- Winship Cancer Institute, Emory UniversityAtlanta, Georgia
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Mar 12, 2024. Always confirm current availability with the study team.