Basket Study of Neratinib in Participants With Solid Tumors Harboring Somatic HER2 or EGFR Exon 18 Mutations

Stopped early · Phase 2

Conditions studied: Solid Tumors Harboring Somatic HER2 or EGFR Exon 18 Mutations

In brief

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.

Key facts

Study ID

NCT01953926

Run by

Puma Biotechnology, Inc.

People needed

582

Starts

2013-09-30

Expected to finish

2023-01-02

Last updated by the study team

2024-03-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Mayo Clinic Arizona — Phoenix, Arizona, United States
• City of Hope — Duarte, California, United States
• University of California, San Diego — La Jolla, California, United States
• University of Southern California — Los Angeles, California, United States
• University of California, Los Angeles — Los Angeles, California, United States
• Stanford Cancer Center — Palo Alto, California, United States
• UCSF Helen Diller Family Comprehensive Cancer Center — San Francisco, California, United States
• Kaiser Permanente NoCal (STRATA) — Vallejo, California, United States
• Mayo Clinic Florida — Jacksonville, Florida, United States
• University of Miami — Miami, Florida, United States
• Winship Cancer Institute, Emory University — Atlanta, Georgia, United States
• Northwestern University — Chicago, Illinois, United States
• Ochsner Clinic Foundation — New Orleans, Louisiana, United States
• Dana Farber Cancer Institute — Boston, Massachusetts, United States
• University of Michigan — Ann Arbor, Michigan, United States
• Mayo Clinic — Rochester, Minnesota, United States
• Metro Minnesota Community Oncology Research Consortium — Saint Louis Park, Minnesota, United States
• Washington University — St Louis, Missouri, United States
• Roswell Park Comprehensive Cancer Center — Buffalo, New York, United States
• Memorial Sloan-Kettering Cancer Center — New York, New York, United States
• UPMC Magee-Woman's Hospital, Women's Cancer Center — Pittsburgh, Pennsylvania, United States
• Saint Francis Cancer Center-Bon Secours — Greenville, South Carolina, United States
• The West Clinic — Germantown, Tennessee, United States
• Vanderbilt-Ingram Cancer Center — Nashville, Tennessee, United States
• University of Alabama at Birmingham — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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