PUMA-NER-5201 Solid tumors harboring somatic HER mutations
Research type
Research Study
Full title
An Open-Label, Phase 2 Basket Study of Neratinib in Patients With Solid Tumors With Somatic Activation HER Mutations
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
2 years, 8 months, 18 days
Research summary
This is an open/label, multicenter, multinational, phase 2 research study, where participating patients will take the investigational drug neratinib. This research study will explore the efficacy and safety of neratinib as monotherapy (single drug) or in combination with other therapies in patients with HER (EGFR, HER2) mutation-positive solid tumors.
The study has a basket design and includes several cohorts. In the course of the study, enrolment in certain cohorts will be completed and enrolment in new cohorts will be initiated to test the anticancer effect of neratinib in other histologies.
Neratinib (study drug): Patient will receive six 40-mg tablets (total daily dose 240 mg) administered orally, once daily with food (recommended to be taken in the morning), continuously.Fulvestrant: Patients will receive 500 mg total dose administered as two 5 mL injections, by intramuscular injection, one in each buttock on Days 1, 15, and 29; then once every 4 weeks thereafter.
Trastuzumab: Patients will receive an initial dose of 8 mg/kg of trastuzumab intravenously (IV)
administered on Cycle 1 Day 1 (C1D1), followed by 6 mg/kg IV once every 3 weeks thereafter.
Paclitaxel: Patients in the bladder/urinary tract cancer cohort treated with combination therapy will receive 80 mg/m2 administered IV on Days 1, 8, and 15 of every 4-week cycle.Patients will continue on study treatment until disease progression, unacceptable toxicity, patient withdrawal of consent, or death. Patients who develop disease progression, but in the opinion of the Investigator would still benefit from continuing study, may continue on per-protocol therapy if approved by the Sponsor. The trial will consist of a screening period, a treatment period, and a follow-up period. An end of treatment assessment will be performed 28 days (+14 days) after the last dose of study drug and adverse events are collected 28 days after the last dose of investigational product(s).
This study is being sponsored by Puma Biotechnology, Inc. It is taking place at several centres in multiple countries. The study will have two activated sites in UK. The approximate duration of the study is 90 months and approximate duration for patient’s participation is 18 months.
REC name
London - Hampstead Research Ethics Committee
REC reference
15/LO/0844
Date of REC Opinion
16 Jun 2015
REC opinion
Favourable Opinion