Breast Cancer Clinical Trial
Basket Study of Neratinib in Participants With Solid Tumors Harboring Somatic HER2 or EGFR Exon 18 Mutations
Summary
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.
Full Description
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.
Eligibility Criteria
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
There are additional inclusion and exclusion criteria. The study center will determine if criteria for participation are met.
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There are 56 Locations for this study
Birmingham Alabama, 35249, United States
Phoenix Arizona, 85054, United States
Duarte California, 91010, United States
La Jolla California, 92093, United States
Los Angeles California, 90089, United States
Los Angeles California, 90095, United States
Palo Alto California, 94304, United States
San Francisco California, 94115, United States
Vallejo California, 94589, United States
Jacksonville Florida, 32224, United States
Miami Florida, 33136, United States
Atlanta Georgia, 30322, United States
Chicago Illinois, 60611, United States
New Orleans Louisiana, 70121, United States
Boston Massachusetts, 02215, United States
Rochester Minnesota, 55905, United States
Saint Louis Park Minnesota, 55416, United States
Saint Louis Missouri, 63110, United States
Buffalo New York, 14263, United States
New York New York, 10065, United States
Pittsburgh Pennsylvania, 15213, United States
Greenville South Carolina, 29607, United States
Germantown Tennessee, 38138, United States
Nashville Tennessee, 37232, United States
Dallas Texas, 75390, United States
Houston Texas, 77030, United States
Seattle Washington, 98109, United States
La Crosse Wisconsin, 54601, United States
Madison Wisconsin, 53792, United States
East Melbourne Victoria, 8006, Australia
Leuven , 3000, Belgium
Vancouver British Columbia, V5Z 4, Canada
Kopenhagen , DK-21, Denmark
Saint-Cloud Ile De France, 92210, France
Villejuif Paris, 94800, France
Bordeaux , 33076, France
Lyon , 69393, France
Dublin Leinster, D04 T, Ireland
Jerusalem , 91120, Israel
Petah Tikva , 49414, Israel
Ramat Gan , 52620, Israel
Rehovot , 76610, Israel
Tel Aviv , 64239, Israel
Cremona , 26100, Italy
Torino , 10126, Italy
Seodaemun-Gu Seoul, 120-7, Korea, Republic of
Belgrade , 11000, Serbia
Barcelona , 08028, Spain
Barcelona , 08035, Spain
Barcelona , 08036, Spain
Madrid , 28040, Spain
Madrid , 28040, Spain
Madrid , 28050, Spain
Madrid , 28223, Spain
Valencia , 46009, Spain
Valencia , 46010, Spain
London , NW3 2, United Kingdom
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