Tazemetostat

Author: Julia Dobke, Martina Nesper-Brock, erstellt am: 2018/09/12, Last modification: 2018/09/12

Tazemetostat A Phase 1 Study of the EZH2 Inhibitor Tazemetostat in Pediatric Subjects with Relapsed or Refractory INI1-Negative Tumors or Synovial Sarcoma
Disease Cohort 1:Atypical teratoid rhabdoid tumor (ATRT) Cohort 2: Malignant rhabdoid tumor (MRT), Rhabdoid tumor of the kidney (RTK) Outside of Germany to include: integrase interactor 1 (INI1) negative tumors or synovial sarcoma
Problem / Objectives
  • To determine the MTD or the RP2D of tazemetostat when administered as an oral suspension BID in pediatric subjects with relapsed/refractory rhabdoid tumors (Escalation phase)
  • To evaluate the antitumor activity of tazemetostat as assessed by overall response rate (ORR) in pediatric subjects with ATRT, MRT or RTK (Expansion phase)
Inclusion Criteria

Key inclusion criteria, expansion phase:
• Age 6 months to 21 years
• Atypical teratoid rhabdoid tumor (ATRT)
• Malignant rhabdoid tumor (MRT), Rhabdoid tumor of the kidney (RTK)
• Lansky Performance Status ≥ 50%…

Exclusion Criteria
  • prior exposure to tazemetostat or other inhibitor(s) of EZH2
  • treatment for another concurrent malignancy or is less than 5 years from completion of treatment for another malignancy
  • participation in another interventional clinical study and received investigational drug within 30 days or five half-lives, whichever is longer, prior to the planned first dose of tazemetostat
  • major surgery within 2 weeks prior to enrollment
  • clinically active heart disease including prolonged QTcF >450 msec
Recruitment Up to 72 subjects are estimated to be enrolled during Dose Expansion
Status recruiting
EudraCT 2015-002468-18
Entry Study Register
Principal Investigator Prof. Dr. med. Michael Frühwald
Contact

PI Germany

Prof. Dr. Dr. med. Michael C. Frühwald Klinikum Augsburg Chefarzt Kinderklinik 1. Klinik für Kinder und Jugendliche Stenglinstr. 2 81656 Augsburg Telefon +49 (821) 400-9201 Fax +49 (821) 400-179201 michael.fruehwald@klinikum-augsburg.de

Participants Augsburg, Berlin, Heidelberg Münster
Sponsoring Epizyme inc., USA