A Phase 1 study of E7386 in patients with advanced Neoplasms
Research type
Research Study
Full title
An Open-Label Multicenter Phase 1 Study of E7386 in Subjects with Selected Advanced Neoplasms
IRAS ID
220636
Contact name
Juliet Alexander
Contact email
Eudract number
2016-004881-25
Clinicaltrials.gov Identifier
NA, NA
Duration of Study in the UK
3 years, 3 months, 22 days
Research summary
The main purpose of the study is to evaluate the safety and tolerability of E7386 in patients with selected tumour types and to identify the maximum tolerated dose/recommended dose for phase 2 studies. The study also evaluates how the body handles the study medication (E7386), and what effect the study medication has on the patient's cancer.
It is a multicentre, open label(the dose given is known to the patient and the investigator), Phase 1 study to be conducted in 2 parts - dose escalation and dose expansion. In the dose expansion part additional patients will enter at the recommended Phase 2 dose in order to evaluate further the safety of the recommended dose identified in the escalation part. A food effect cohort will also be explored at this point to explore the role of food on E7386.
The dose escalation part of the study will be conducted in the UK, and the dose expansion part will be conducted in the UK, USA and potentially one other European Country. It is estimated that 140 patients will enter the study in total and it will run over 3 years.
Initially patients will undergo certain procedures to confirm that they are eligible for the study. Whilst on the study medication patients will visit the hospital weekly for the first 4 weeks to complete assessments in order to monitor the safety and their response to the study medication. The number of visits reduces the longer the patient stays in the trial. Patients may remain on study unless their cancer worsens, unacceptable toxicity is documented, or they withdraw their consent.
REC name
London - Surrey Borders Research Ethics Committee
REC reference
17/LO/0660
Date of REC Opinion
2 Jun 2017
REC opinion
Further Information Favourable Opinion