A Randomized, Double-Blind, Phase 3 Trial Of Maintenance With Selinexor/Placebo After Combination Chemotherapy For Patients With Advanced Or Recurrent Endometrial Cancer
Patients with recurrent and advanced endometrial cancer with response after first or second-line chemotherapy will be randomized to maintenance therapy with 80 mg selinexor once weekly or placebo until progression. The purpose of this research study is to see if selinexor can help keep endometrial cancer in remission.
Primary Objective: To evaluate and compare the efficacy of selinexor compared to placebo, as assessed by the investigator, as maintenance therapy in patients with advanced or recurrent endometrial cancer. Secondary Objectives: To evaluate and compare the efficacy of selinexor compared to placebo, as assessed by a blinded independent central review(BICR), to evaluate and compare selinexor and placebo on survival rates, to evaluate and compare selinexor and placebo for time to subsequent therapies, to evaluate and compare selinexor and placebo for efficacy on subsequent therapy, to evaluate and compare selinexor and placebo for disease control, to evaluate health-related quality of life (HR-QoL) outcomes, to assess the safety and tolerability of selinexor. Exploratory Objectives: To evaluate and compare selinexor and placebo on tumor response rate, to evaluate and compare selinexor and placebo on duration of response, to identify predictive biomarkers of response to treatment and explore treatment mechanism of action using genomics analyses, and to evaluate the pharmacokinetics (PK) of selinexor used as maintenance therapy.
KPT-330 (Selinexor); Placebo (); Selinexor ()
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