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

PI Germany

Univ. Prof. Dr. Dr. med. Michael C. Frühwald Universitätsklinikum Augsburg Kinderklinik Augsburg / Mutter-Kind-Zentrum Schwaben / Schwäbisches Kinderkrebszentrum Stenglinstr. 2 81656 Augsburg Telefon +49 (821) 400-9201 Fax +49 (821) 400-179201 michael.fruehwald@uk-augsburg.de

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