Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at La Jolla, California and other locations
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 (for example HER2 mutant cervical cancer).

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 lasting for a maximum of 12 months for each participant after their last dose of neratinib or until initiation of additional anti-cancer therapy.

Keywords

Solid Tumors Harboring Somatic HER2 or EGFR Exon 18 Mutations Neratinib Nerlynx Breast Solid Tumors Cancer HER2 mutations EGFR mutations Bladder/Urinary Tract Paclitaxel Fulvestrant Trastuzumab Cervical Salivary Neratinib monotherapy Neratinib and Paclitaxel 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, tucatinib, poziotinib)
  • 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 Southern California accepting new patients
    Los Angeles California 90089 United States
  • University of California, Los Angeles accepting new patients
    Los Angeles California 90095 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Puma Biotechnology, Inc.
Links
HER Kinase Inhibition in Patients With HER2- And HER3-mutant Cancers Efficacy and Determinants of Response to HER Kinase Inhibition in HER2 -Mutant Metastatic Breast Cancer
ID
NCT01953926
Phase
Phase 2
Study Type
Interventional
Last Updated