Summary

for people ages 18 years and up (full criteria)
at La Jolla, California and other locations
study started
estimated completion

Description

Summary

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.

Official Title

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.

Details

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.

Keywords

Malignant Solid TumorFibrolamellar CarcinomaNeratinibNerlynxBreastGastroesophagealEndometrialOvarianBiliary TractSolid TumorsCancerHER2HER4EGFRBladder/Urinary TractPaclitaxelFulvestrantTrastuzumabCarcinoma, HepatocellularAlbumin-Bound PaclitaxelNeratinib monotherapyNeratinib and PaclitaxelNeratinib, Fulvestrant and TrastuzumabNeratinib and Trastuzumab

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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.

You CAN'T join if...

  • 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.

Locations

  • University of California, San Diegoaccepting new patients
    La JollaCalifornia92093United States
  • City of Hopeaccepting new patients
    DuarteCalifornia91010United 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