SELINEXOR COMPARED TO PHYSICIANS CHOICE IN RELAPSED OR REFRACTORY AML

• Research type

  Research Study

• Full title

  A RANDOMIZED, OPEN LABEL, PHASE 2 STUDY OF THE SELECTIVE INHIBITOR OF NUCLEAR EXPORT (SINE) SELINEXOR (KPT-330) VERSUS SPECIFIED PHYSICIAN’S CHOICE IN PATIENTS = 60 YEARS OLD WITH RELAPSED/REFRACTORY ACUTE MYELOID LEUKEMIA (AML) WHO ARE INELIGIBLE FOR INTENSIVE CHEMOTHERAPY AND/OR TRANSPLANTATION

• IRAS ID

  158383

• Contact name

  Jana von Hehn

• Contact email

  jana@karyopharm.com

• Sponsor organisation

  Karyopharm Therapeutics Inc.

• Eudract number

  2014-000920-26

• Clinicaltrials.gov Identifier

  NCT02088541

• Duration of Study in the UK

  0 years, 10 months, 31 days

• Research summary

  The study aims to compare treatment with the study drug Selinexor (KPT-330) to treatment with a physician’s choice of one of three conventional care regimens in patients older than 60 years of age with Acute Myeloid Leukemia (AML). Eligible patients should be relapsed (their disease has returned after a period of improvement) or refractory to treatment (unresponsive to current treatments). Patients should also be ineligible for both intensive chemotherapy and transplantation.

• REC name

  North West - Liverpool Central Research Ethics Committee

• REC reference

  14/NW/1358

• Date of REC Opinion

  29 Oct 2014

• REC opinion

  Favourable Opinion