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

NCT01953926 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 582

Last updated 2024-03-12

Study results available
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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.

Conditions

  • Solid Tumors Harboring Somatic HER2 or EGFR Exon 18 Mutations

Interventions

DRUG

Neratinib

240 mg administered orally, once daily with food, continuously in 28 day cycles

DRUG

Fulvestrant

500 mg administered as two 5 mL injections on Days 1, 15, and 29; then once every 4 weeks thereafter month, then Day 1 of every 4 week cycle

DRUG

Trastuzumab

Initial dose of 8 mg/kg of trastuzumab administered IV on Day 1, followed by 6 mg/kg IV once every 3 weeks thereafter

DRUG

Paclitaxel

80mg/m\^2 administered IV on Days 1, 8, and 15 of every 4 week cycle

Sponsors & Collaborators

  • Puma Biotechnology, Inc.

    lead INDUSTRY

Principal Investigators

  • Chief Scientific Officer · Puma Biotechnology, Inc.

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-09-30
Primary Completion
2023-01-02
Completion
2023-01-02
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Belgium
  • Canada
  • Denmark
  • France
  • Ireland
  • Israel
  • Italy
  • Serbia
  • South Korea
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01953926 on ClinicalTrials.gov