An Open-Label, Phase 2 Study of Neratinib in Patients With Solid Tumor
Research type
Research Study
Full 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
IRAS ID
171670
Contact name
Richard Bryce
Contact email
Sponsor organisation
Puma Biotechnology, Inc
Eudract number
2013-002872-42
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 7 months, 1 days
Research summary
This is an open-label, non-randomized, multicenter, multinational, Phase 2 study exploring the efficacy and safety of neratinib monotherapy in patients with ERBB mutation-positive or EGFR gene amplified solid tumors. Patients with ERBB mutation-positive cancers will be identified through mutation analysis assays as routinely performed at each participating site according to their local laboratory procedures. The presence of a human epidermal growth factor receptor mutation (EGFR, HER2, HER3) will be retrospectively confirmed by centralized testing. The trial will consist of a screening period, a treatment period, safety follow-up and end of treatment (EOT)
assessments when neratinib is discontinued for any reason, performed 28 days (+14 days) after the last dose of neratinib, follow-up for disease progression every 8 weeks, and a survival follow-up period. Treatment will consist of neratinib by mouth with food once daily in the morning administered on a continuous basis.REC name
East Midlands - Nottingham 2 Research Ethics Committee
REC reference
15/EM/0137
Date of REC Opinion
31 Mar 2015
REC opinion
Unfavourable Opinion