Basket Study of Neratinib in Participants With Solid Tumors Harboring Somatic HER2 or EGFR Exon 18 Mutations
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
Alabama
Birmingham
Arizona
Scottsdale
California
Duarte
Los Angeles
Newport Beach
Palo Alto
San Diego
San Francisco
Florida
Jacksonville
Miami
Georgia
Atlanta
Illinois
Chicago
Massachusetts
Boston
Michigan
Ann Arbor
Minnesota
Rochester
Missouri
Saint Louis
New Jersey
New Brunswick
New York
Buffalo
New York
Pennsylvania
Pittsburgh
Willow Grove
Tennessee
Nashville
Texas
Dallas
Houston
Washington
Seattle
Wisconsin
Madison
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. The study has a basket
design and includes several cohorts, either defined by an actionable somatic mutation or by
actionable mutation and tumor histology, including HER2 mutant breast, HER2 mutant cervical,
HER2 mutant salivary gland, and EGFR Exon 18 mutant Non-small cell lung cancers.
The trial will consist of a screening period, a treatment period, and an end of treatment
visit occurring when neratinib is discontinued for any reason, a safety follow-up visit
occurring 28 days after the last dose of neratinib and a survival follow-up period.
Trial Phase Phase II
Trial Type Treatment
Lead Organization
Puma Biotechnology, Inc.
- Primary ID PUMA-NER-5201
- Secondary IDs NCI-2014-00495, 2013-002872-42
- Clinicaltrials.gov ID NCT01953926