Neratinib HER Mutation Basket Study
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, tucatinib, poziotinib)
- 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 (for example HER2 mutant cervical cancer). 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 lasting for a maximum of 12 months for each participant after their last dose of neratinib or until initiation of additional anti-cancer therapy.
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