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

Trial Status: Active

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.

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
University of Alabama at Birmingham Cancer Center
Status: ACTIVE
Contact: Eddy Shih-Hsin Yang
Phone: 205-996-0780

Arizona

Scottsdale
Mayo Clinic in Arizona
Status: CLOSED_TO_ACCRUAL

California

Duarte
City of Hope Comprehensive Cancer Center
Status: ACTIVE
Los Angeles
Los Angeles County-USC Medical Center
Status: ACTIVE
Contact: Cheryl Kefauver
Phone: 323-865-0845
UCLA / Jonsson Comprehensive Cancer Center
Status: ACTIVE
Contact: Jonathan W. Goldman
Phone: 310-633-8400
USC / Norris Comprehensive Cancer Center
Status: ACTIVE
Contact: David Ian Quinn
Phone: 323-865-0451
Newport Beach
Hoag Memorial Hospital
Status: ACTIVE
Contact: Cristina de Leon
Phone: 949-764-5543
Palo Alto
Stanford Cancer Institute Palo Alto
Status: ACTIVE
San Diego
University of California San Diego
Status: ACTIVE
San Francisco
UCSF Medical Center-Mount Zion
Status: CLOSED_TO_ACCRUAL
Contact: Helen Diller Family Comprehensive Cancer Center
Phone: 877-827-3222

Florida

Jacksonville
Mayo Clinic in Florida
Status: CLOSED_TO_ACCRUAL
Miami
University of Miami Miller School of Medicine-Sylvester Cancer Center
Status: CLOSED_TO_ACCRUAL

Georgia

Atlanta
Emory University Hospital / Winship Cancer Institute
Status: ACTIVE

Illinois

Chicago
Northwestern University
Status: ACTIVE

Massachusetts

Boston
Beth Israel Deaconess Medical Center
Status: ACTIVE
Boston Children's Hospital
Status: ACTIVE
Brigham and Women's Hospital
Status: ACTIVE
Dana-Farber Cancer Institute
Status: ACTIVE
Contact: Geoffrey Ira Shapiro
Phone: 866-790-4500
Massachusetts General Hospital Cancer Center
Status: ACTIVE
Contact: Dejan Juric
Phone: 877-726-5130

Michigan

Ann Arbor
University of Michigan Comprehensive Cancer Center
Status: ADMINISTRATIVELY_COMPLETE

Minnesota

Rochester
Mayo Clinic in Rochester
Status: ACTIVE

Missouri

Saint Louis
Siteman Cancer Center at Washington University
Status: ACTIVE
Contact: Haeseong Park
Phone: 314-747-7401

New Jersey

New Brunswick
Rutgers Cancer Institute of New Jersey
Status: ADMINISTRATIVELY_COMPLETE

New York

Buffalo
Roswell Park Cancer Institute
Status: ACTIVE
New York
Memorial Sloan Kettering Cancer Center
Status: ACTIVE
Contact: David Michael Hyman
Phone: 212-639-7202

Pennsylvania

Pittsburgh
University of Pittsburgh Cancer Institute (UPCI)
Status: ACTIVE
Contact: Adam Matthew Brufsky
Phone: 412-647-2811
Willow Grove
Abington Memorial Hospital-Asplundh Cancer Pavilion
Status: TEMPORARILY_CLOSED_TO_ACCRUAL

Tennessee

Nashville
Vanderbilt University / Ingram Cancer Center
Status: ACTIVE
Contact: Ingrid Alina Mayer
Phone: 615-936-3831

Texas

Dallas
UT Southwestern / Simmons Cancer Center-Dallas
Status: ACTIVE
Contact: Marcella West Aguilar
Phone: 214-648-1479
Houston
M D Anderson Cancer Center
Status: ACTIVE
Contact: Sarina A. Piha-Paul
Phone: 713-792-3245

Washington

Seattle
Fred Hutch / University of Washington Cancer Consortium
Status: IN_REVIEW

Wisconsin

Madison
University of Wisconsin Hospital and Clinics
Status: ACTIVE

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