A Study on the Effect of E7438 in Patients with Advanced Tumors
Research type
Research Study
Full title
An Open-Label, Multicenter, Phase 1/2 Study of E7438 (EZH2 Histone Methyl Transferase [HMT] inhibitor) as a Single Agent in Subjects With Advanced Solid Tumors or With B cell Lymphomas
IRAS ID
154916
Contact name
Peter Johnson
Contact email
Sponsor organisation
Eisai Limited
Eudract number
2012-004083-21
Clinicaltrials.gov Identifier
Research summary
This is a study of an investigational drug, called E7438 (EZH2 Histone Methyl Transferase [HMT] Inhibitor) to treat patients with Advanced solid tumors or with B cell Lymphomas.
The study will be conducted in two parts. The Phase 1 part will comprise dose escalation and establishment of the maximum tolerated dose (MTD).
Once the MTD has been confirmed and a Phase 2 dose has been recommended, the Phase 2 part will determine the safety and activity of E7438 in EZH2 mutation positive subjects. During Stage 2, subjects will be randomised (i.e. chosen by chance, like the flip of a coin) to receive either the E7438 treatment or standard of care treatment.
About 154 patients are expected to take part from approximately 20 clinics/hospitals in Europe.
After undergoing certain screening procedures, suitable patients will be enrolled in the trial. Whilst in the study, patients will undergo several treatment cycles and have the following study procedures performed: physical examinations, vital signs recorded, Echocardiogram, skin biopsy punch, CT/MRI scans, ECG, blood and urine samples taken for laboratory assessments.
Blood, urine samples taken for PK and PD assessments, genomic DNA.
The number of treatment cycles a patient may receive is not fixed and so a patient’s length of participation in the study will depend on how they respond to the study treatment.
Subjects with confirmation of disease progression by the investigator and sponsor while receiving standard of care therapy will be eligible to receive optional E7438 treatment and enter into the optional crossover treatment period of the extension.
REC name
South Central - Berkshire Research Ethics Committee
REC reference
14/SC/1195
Date of REC Opinion
1 Sep 2014
REC opinion
Unfavourable Opinion