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Neratinib HER Mutation Basket Study (SUMMIT)

Trial Status: Active

This is an open-label, non-randomized, multicenter, multinational, Phase 2 study exploring the efficacy and safety of neratinib as monotherapy or in combination with other therapies in patients with ERBB mutation-positive or EGFR gene-amplified solid tumors.

Inclusion Criteria

  • Histologically confirmed cancers for which no curative therapy exists.
  • Documented HER2 mutation.
  • Pediatric patients (at least 12 but less than 18 years of age at signing of informed consent) may be recruited in the Fibrolamellar Carcinoma cohort.

Exclusion Criteria

  • Prior treatment with any pan-HER tyrosine kinase inhibitor (eg, lapatinib, afatinib, dacomitinib, neratinib).
  • Patients 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
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
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: ACTIVE
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
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: ACTIVE

Tennessee

Nashville
Vanderbilt University / Ingram Cancer Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
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

Wisconsin

Madison
University of Wisconsin Hospital and Clinics
Status: ACTIVE

This is an open-label, multicenter, multinational, Phase 2 study exploring the efficacy and safety of neratinib therapy in patients with solid tumors with activating HER2, HER3 or EGFR mutations or with EGFR gene amplification. 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 to 42 days after the last dose of neratinib and a survival follow-up period lasting for a maximum of 12 months for each patient 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