Phase IIA trial of EZH2 inhibition in mesothelioma
Research type
Research Study
Full title
A Phase 2, Multicenter Study of the EZH2 Inhibitor Tazemetostat in Adult Subjects with Relapsed or Refractory Malignant Mesothelioma with BAP1 Loss of Function.
IRAS ID
204761
Contact name
Dean Fennell
Contact email
Sponsor organisation
Epizyme Inc
Eudract number
2016-001139-10
Duration of Study in the UK
2 years, 0 months, 0 days
Research summary
The purpose of Part 1 of this study is to assess the pharmacokinetic (PK) and safety profile of single and repeated doses of 800 mg tazemetostat administered as 400 mg tablets in subjects with relapsed or refractory malignant mesothelioma regardless of BAP1 status and to assess the disease control rate.
The purpose of Part 2 of this study is to assess disease control rate (DCR) at 12 weeks [consisting of complete response (CR), partial response (PR) or stable disease (SD)] according to modified RECIST [Nowak, 2005] for thoracic disease or RECIST 1.1 elsewhere in subjects with relapsed or refractory BAP1-deficient malignant mesothelioma treated with tazemetostat.
The sponsor’s research information shows that Tazemetostat targets and kills certain cancer cells by stopping a gene called EZH2 from working. EZH2 is also involved in how the gene BAP1 works in cells. Tazemetostat has been shown to slow down the growth of, or kill, cancer cells that are missing the BAP1 gene in some way. Uveal melanoma, clear cell renal carcinoma, and mesothelioma, when tested can be missing BAP1 and are called BAP1 negative or BAP1-deficient.
Epizyme Inc, is sponsoring this study; approximately 67 patients (aged ≥18 years) will be recruited into the study in the US, France and UK.REC name
South Central - Berkshire Research Ethics Committee
REC reference
16/SC/0341
Date of REC Opinion
19 Jul 2016
REC opinion
Further Information Favourable Opinion