Neratinib HER Mutation Basket Study (SUMMIT)



Status:Recruiting
Conditions:Liver Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:2/13/2019
Start Date:September 30, 2013
End Date:March 2022
Contact:Puma Biotechnology Clinical Operations Senior Director
Email:ClinicalTrials@pumabiotechnology.com
Phone:(424) 248-6500

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An Open-label, Phase 2 Study of Neratinib in Patients With Solid Tumors With Somatic Human Epidermal Growth Factor Receptor (EGFR, HER2, HER3) Mutations or EGFR Gene Amplification.

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.

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.

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.

Note: There are additional inclusion and exclusion criteria. The study center will
determine if you meet all of the criteria.
We found this trial at
28
sites
Los Angeles, California 90033
213) 740-2311
University of Southern California The University of Southern California is one of the world’s leading...
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Los Angeles, California 90095
310-825-4321
University of California at Los Angeles The University of California, Los Angeles (UCLA) is an...
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Los Angeles, CA
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Miami, Florida 33124
(305) 284-2211
University of Miami A private research university with more than 15,000 students from around the...
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Miami, FL
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2220 Pierce Ave
Nashville, Tennessee 37232
615-936-8422
Vanderbilt-Ingram Cancer Center The Vanderbilt-Ingram Cancer Center, located in Nashville, Tenn., brings together the clinical...
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Nashville, TN
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1600 Divisadero Street
San Francisco, California 94115
888.689.8273
UCSF Helen Diller Family Comprehensive Cancer Center UCSF’s long tradition of excellence in cancer research...
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San Francisco, CA
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500 S State St
Ann Arbor, Michigan 48109
(734) 764-1817
University of Michigan The University of Michigan was founded in 1817 as one of the...
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Ann Arbor, MI
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450 Brookline Ave
Boston, Massachusetts 2215
617-632-3000
Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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Boston, MA
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665 Elm Street
Buffalo, New York 14263
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Buffalo, NY
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303 East Superior Street
Chicago, Illinois 60611
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Chicago, IL
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2201 Inwood Rd
Dallas, Texas 75235
(214) 645-8300
U.T. Southwestern Medical Center The story of UT Southwestern Medical Center is one of commitment...
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Dallas, TX
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Duarte, California 91010
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East Melbourne, Victoria
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Germantown, Tennessee 38138
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Houston, Texas 77030
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Houston, TX
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4500 San Pablo Rd S
Jacksonville, Florida 32224
(904) 953-2000
Mayo Clinic Florida Thousands of people come to Mayo Clinic in Jacksonville, Fla., annually for...
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Jacksonville, FL
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3535 Southern Blvd
Kettering, Ohio 45429
(937) 298-4331
Kettering Medical Center Our flagship hospital, Kettering Medical Center, stands proudly in Kettering, Ohio. From...
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La Crosse, Wisconsin 54601
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9500 Gilman Dr
La Jolla, California 92093
(858) 534-2230
The University of California, San Diego UC San Diego is an academic powerhouse and economic...
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La Jolla, CA
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600 Highland Ave.
Madison, Wisconsin 53792
(608) 263-6400
University of Wisconsin Carbone Cancer Center UW Carbone Cancer Center holds the unique distinction of...
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New Brunswick, New Jersey 08903
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New Orleans, Louisiana 70121
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New Orleans, LA
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1275 York Ave
New York, New York 10021
(212) 639-2000
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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Palo Alto, California 94304
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Phoenix, Arizona 85054
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300 Halket Street
Pittsburgh, Pennsylvania 15213
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Rochester, Minnesota 55905
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Rochester, MN
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Saint Louis, Missouri 63110
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Saint Louis Park, Minnesota 55416
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