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TerminatedPhase 2NCT01953926
Official study title

Basket Study of Neratinib in Participants With Solid Tumors Harboring Somatic HER2 or EGFR Exon 18 Mutations

Study 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.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedNeratinib and Fulvestrant

Plus 2 other study approaches.

Who it may be forEGFR · HER2

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Mar 12, 2024 · Source: ClinicalTrials.gov

Is enrollment open?Terminated

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 2

Interventional

Where is it offered?60 U.S. locations

Locations may change over time.

Who runs it?Puma Biotechnology, Inc.

Study sponsor

01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 2
Sponsor
Puma Biotechnology, Inc.
Interventions being studied
Drug: Neratinib; Drug: Fulvestrant; Drug: Trastuzumab; Drug: Paclitaxel
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

Biomarkers
EGFR→HER2→
Treatment approach
Chemotherapy→
03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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
Reasons someone may not be able to joinExclusion 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

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • University of Alabama at BirminghamBirmingham, Alabama
  • Mayo Clinic ArizonaPhoenix, Arizona
  • City of HopeDuarte, California
  • University of California, San DiegoLa Jolla, California
  • University of Southern CaliforniaLos Angeles, California
  • University of California, Los AngelesLos Angeles, California
  • Stanford Cancer CenterPalo Alto, California
  • UCSF Helen Diller Family Comprehensive Cancer CenterSan Francisco, California
  • Kaiser Permanente NoCal (STRATA)Vallejo, California
  • Mayo Clinic FloridaJacksonville, Florida
  • University of MiamiMiami, Florida
  • Winship Cancer Institute, Emory UniversityAtlanta, Georgia

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Mar 12, 2024. Always confirm current availability with the study team.

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