drugset / Trial / NCT02025985

Study of KPT-330 (Selinexor) in Female Patients With Advanced Gynaecologic Malignancies

NCT02025985

Phase 2 Completed 116 enrolled Karyopharm Therapeutics Inc
RandomizedParallel-groupOpen-labelTreatment

Summary

The primary trial objective is to determine the efficacy of KPT-330 (selinexor) in participants with advanced or metastatic gynaecological cancers by disease control rate (complete response (CR) or partial response (PR) or stable disease (SD) for at least 12 weeks, assessed according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.

Timeline

Start
2014-04-09
Primary completion
2017-01-24
Completion
2017-03-29

Drugs

EvaluationDrugModalityDoseRoute
Subject Selinexor Other / unclassified 50 mg/m2 Oral
Subject Selinexor Other / unclassified 60 mg/m2 Oral