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Study Name

GOG 3083 XPORT-EC

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

Start Date

Enrollment Status

Enrolling new patients

Sponsor

Karyopharm Therapeutics Inc

Study Type

endometrial

Location

Willis-Knighton Cancer Center
2600 Kings Hwy Shreveport, LA 71103
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Main Inclusion
  • At least 18 years of age at the time of signing informed consent.
  • Written informed consent signed in accordance with federal, local, and institutional
    guidelines prior to the first screening procedure.
  • Histologically confirmed EC including: endometrioid, serous, undifferentiated, and
    carcinosarcoma.
  • Must be able to initiate study drug 3 to 8 weeks after completion of their final dose of
    chemotherapy.
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Exclusion Criteria
  • Has any uterine sarcomas (carcinosarcomas – not excluded), clear cell or small cell
    carcinoma with neuroendocrine differentiation
  • Received a blood or platelet transfusion during the 2 weeks prior to first cycle
  • Major injuries or surgery within 14 days prior to C1D1 and/or planned major surgery
    during the on-treatment study period
  • Females who are pregnant
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Treatment Information

Compliance to oral Sponsor-supplied study drug taken at home will be assessed by the
Investigator and/or study personnel at each visit and recorded in source documents after
discussion with the patient and after performing Sponsor-supplied study drug accountability.

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Costs & Stipend Details
  • Patients will be provided a travel stipend
  • Research Medications and treatment are provided at no charge.
  • Medication, treatment, and testing considered standard of care will be billed to the patient’s insurance carrier
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General Information

The objective of this study is to evaluate the efficacy of selinexor compared to placebo as maintenance therapy.

Ready to Participate?

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