Selinexor (KPT-330) in Older Patients With Relapsed/Refractory AML (SOPRA) | Aplastic Anemia and MDS International Foundation

ClinicalTrials.gov Identifier:

NCT02088541

Company

Contact Info

Maxine Foote

MFoote@karyopharm.com

Dates

Start: March 2014
End: June 2017

Official Title

Selinexor (KPT-330) in Older Patients With Relapsed/Refractory AML (SOPRA)

Purpose

This is a randomized, multicenter, open-label, Phase 2 study of the oral SINE™ compound selinexor in patients 60 years of age or older with relapsed or refractory AML who are ineligible for standard intensive chemotherapy and/or transplantation. In the Selinexor in Older Patient with Relapsed/Refractory AML (SOPRA) study, Karyopharm is evaluating approximately 170 patients who have AML that has relapsed after, or was refractory to, first line therapy. Patients are randomized in a 2:1 fashion to selinexor provided orally twice weekly in a dose of 60mg plus best supportive care (BSC) versus one of three physician choices. Patients must have received at least one prior line of AML therapy given at standard doses and must have progressed after their most recent therapy. Prior therapy must have included at least two cycles of a hypomethylating agent. Physician choices include (i) BSC alone, (ii) BSC plus either azacytidine or decitabine or (iii) BSC plus low-dose Ara-C. Overall survival is the primary endpoint.

Instructions

If you are interested in learning more about your possible participation in this clinical trial, please complete the form. Your information will be forwarded directly to the sponsoring company.

Status: 
Recruiting
Phase: 
Phase 2
Gender: 
Female
Male
Age Group: 
18 years and older
Accepts Healthy Volunteers: 
No
Inclusion Criteria: 
  • Age ≥ 60 years with relapsed/refractory AML of any type except for acute promyelocytic leukemia (APL; AML M3), after at least 1 prior AML therapy , who have never undergone, and who are not currently eligible for, stem cell transplantation, and are currently deemed unfit for intensive chemotherapy.
  • ECOG ≤ 2.
  • Must have available archival or recently acquired bone marrow biopsy/aspiration or tumor tissue for central review to be eligible.
  • Relapsed or refractory AML, defined as either: recurrence of disease after a complete remission (CR), or failure to achieve CR with initial therapy.
  • Must have received at least 1 prior line of AML therapy given at standard doses and must have progressed after most recent therapy. Prior therapy must have included a hypomethylating agent with at least 2 cycles.
Exclusion Criteria: 
  • Treatment with any investigational agent within 3 weeks prior to first dose in this study.
  • Presence of central nervous system (CNS) leukemia.
  • In blast transformation of chronic myeloid leukemia (CML). Prior myelodysplastic syndrome (MDS) is acceptable; prior treatment for MDS does not count as an AML therapy.
  • Major surgery within 2 weeks of first dose of study drug. Patients must have recovered from the effects of any surgery performed greater than 2 weeks previously.
  • Concurrent active malignancy under treatment.
  • Known active hepatitis B virus (HBV) or C virus (HCV) infection; or known to be positive for HCV ribonucleic acid (RNA) or HBsAg (HBV surface antigen).
  • Known HIV infection.
  • Unable to swallow tablets, or patients with malabsorption syndrome, or any other disease significantly affecting gastrointestinal function.
  • Patients whose AML is classified as favorable according to the European LeukemiaNet (ELN) disease risk assessment.

Find Out More:

Disclaimer:

AAMDSIF does not recommend, endorse, or make any representation about the efficacy, appropriateness or suitability of any clinical trial listed on this website. Pharmaceutical company sponsored content is highlighted only to give additional information about the trial. All trials are listed on https://clinicaltrials.gov/. Always seek the advice of your physician or other qualified health care provider with any questions you may have regarding a clinical trial, and never disregard professional medical advice or delay in seeking it because of something you have read on this website.