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ENDOMETRIAL: ADVANCED: MAINTENANCE: p53 WT: XPORT-EC-042

A Phase 3, Randomized, Placebo-Controlled, Double-Blind, Multicenter Trial of Selinexor in Maintenance Therapy After Systemic Therapy for Patients With p53 Wild-Type, Advanced or Recurrent Endometrial Carcinoma

Title
Karyopharm XPORT-EC-042 (Endometrial p53WT maintenance)
Study Title

A Phase 3, Randomized, Placebo-Controlled, Double-Blind, Multicenter Trial of Selinexor in Maintenance Therapy After Systemic Therapy for Patients With p53 Wild-Type, Advanced or Recurrent Endometrial Carcinoma

Site Link
Malignancy
Endometrial
Stage
Disease Setting
Advanced or recurrent
Line Of Therapy
Maintenance
Investigational Agent
Selinexor
Drug Class
Selective inhibitor of nuclear export (SINE)
PI
Todd Tillmanns, MD
Sponsor
Karyopharm Therapeutics, Inc
Phase
Status
Key Eligibility Criteria
Key Eligibility Criteria Details
  • Histologically confirmed EC including: endometrioid, serous, undifferentiated, and carcinomsarcoma
  • TP53 WT assessed by NGS via central vendor
  • Completed a single line, at least 12 weeks, of platinum-based therapy (not including adjuvant or neoadjuvant tx for Stage 1-II disease) adn achieved confirmed PR or CR by RECIST.
  • If Primary Stage IV, may have had surgery or not. If surgery, must have had R0 or R1 resection
  • Must be able to initiate study drug 3-8 weeks following completion of final dose of chemo
  • ECOG PS 0-1
  • No uterine sarcoma
  • No concurrent systemic steroid therapy above 10mg prednisone or equivalent
  • No previous treatment with an XPO1 inhibitor
  • No active brain mets
Objective
  • Primary
    • PFS
  • Secondary
    • OS
    • Safety
    • Time to first subseqent therapy
    • Time to second subsequent therapy
    • PFS2
    • QOL
Assessment Frequency
_
Assessment Frequency 2
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Assessment Frequency Link
Path
Endometrioid, serous, undifferentiated, or carcinosarcoma
Dosing Frequency
Control Agents
Study Protocol
Randomized
Yes
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