Phase 1 open label study of Tazemetostat
Research type
Research Study
Full title
A Phase I, Open-label Multi-dose Pharmacokinetic and Safety Study of Oral Tazemetostat in Subjects with Moderate and Severe Hepatic Impairment with Advanced Malignancies
IRAS ID
1003266
Contact name
Omi Parikh
Contact email
Eudract number
2019-003368-36
Clinicaltrials.gov Identifier
Research summary
Tazemetostat (EPZ-6438) impacts a gene called EZH2 which is active in cancer cells.\nTazemetostat targets and kills certain cancer cells. Tazemetostat is considered an\nexperimental study medication that has not yet been approved. This study intends to find\nout what effects it has on participants and in the treatment of cancer.\nThis study will enrol participants that have cancer that has spread to different parts of\nthe body after receiving certain types of therapy. The purpose of this study is to evaluate\nthe pharmacokinetics (PK) and safety of tazemetostat in participants with advanced\ncancer who have normal or abnormal function of the liver.\n24 people will take part in this study at about 15 study sites worldwide. This research\nstudy is divided into 2 parts. Part 1 involves taking tazemetostat (study medication) and\ncollecting samples for PK analysis for approximately 11 weeks. Participation in Part 1 is\nrequired in order to take part in the whole study. Participants may then enter Part 2,\nwhich is optional and involves continuous treatment with the study medication twice a\nday.\nParticipants in Part 2 will continue to receive the study medication until their cancer\nprogresses, they do not tolerate study medication, the study doctor decides that they can\nno longer participate, or withdrawal of consent.
REC name
East of England - Cambridgeshire and Hertfordshire Research Ethics Committee
REC reference
20/EE/0167
Date of REC Opinion
27 Aug 2020
REC opinion
Further Information Favourable Opinion