Phase 2 Open-Label Study of Eltanexor in Patients with high risk nonresponsive MDS

• Research type

  Research Study

• Full title

  A Phase 2 Open-Label Study of the Safety, Tolerability and Efficacy of the Selective Inhibitor of Nuclear Export (SINE) Compound Eltanexor (KPT-8602) in Patients with Refractory Myelodysplastic Syndrome

• IRAS ID

  1004593

• Contact name

  Ran Frenkel

• Contact email

  rfrenkel@karyopharm.com

• Sponsor organisation

  Karyopharm Therapeutics, Inc.

• Eudract number

  2021-003810-38

• Research summary

  The purpose of this study is to test the safety and efficacy of the study drug (eltanexor) in patients with high-risk primary refractory myelodysplastic syndrome (MDS). Cancer cells continue to grow by getting rid of proteins called “tumor suppressor proteins” that would normally cause cancer cells to die. The study drug works by trapping tumor suppressor proteins within the nucleus and thereby causes cancer cells to die or stop growing. This is a global study, where sites from at least 5 countries will participate and estimated to complete enrollment summer of 2022.
  This study drug eltanexor works by trapping “tumor suppressing proteins” within the nucleus of the cell and thus causing the cancer cells to stop growing or die.

• REC name

  East of England - Cambridge South Research Ethics Committee

• REC reference

  22/EE/0015

• Date of REC Opinion

  4 Apr 2022

• REC opinion

  Further Information Favourable Opinion