NCT01953926

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

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 582 (actual)
• Sponsor: Puma Biotechnology, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Solid Tumors Harboring Somatic HER2 or EGFR Exon 18 Mutations

Interventions

Type	Name	Description
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

Timeline

• Start date: 2013-09-30
• Primary completion: 2023-01-02
• Completion: 2023-01-02
• First posted: 2013-10-01
• Last updated: 2024-03-12
• Results posted: 2024-03-12

Locations

60 sites across 13 countries: United States, Australia, Belgium, Canada, Denmark, France, Ireland, Israel, Italy, Serbia, South Korea, Spain, United Kingdom

Regulatory

• FDA-regulated drug study