Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCLA UCSD UCSF
Dates
study started
estimated completion

Description

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.

Official Title

An Open-Label, Phase 2 Basket Study of Neratinib in Patients With Solid Tumors With Somatic Activating HER Mutations

Details

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.

Keywords

Solid Tumors Harboring Somatic HER2 or EGFR Exon 18 Mutations Neratinib Nerlynx Breast Solid Tumors Cancer HER2 mutations EGFR mutations Fulvestrant Trastuzumab Cervical Salivary ERBB2 Exon 18 Metastatic HR Positive Lung Non-Small Cell Lung Cancer (NSCLC) Neoplasms Neratinib monotherapy Neratinib and Trastuzumab

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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 CAN'T join 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.

Locations

  • University of California, San Diego accepting new patients
    La Jolla California 92093 United States
  • University of California, Los Angeles accepting new patients
    Los Angeles California 90095 United States
  • UCSF Helen Diller Family Comprehensive Cancer Center in progress, not accepting new patients
    San Francisco California 94115 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Puma Biotechnology, Inc.
ID
NCT01953926
Phase
Phase 2
Study Type
Interventional
Last Updated