CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 116 enrolled
Drug / intervention
Selinexordrug
Likely dose
Selinexor 35 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02025985
NCT02025985Phase 2Completed
CompareCT.gov

A Phase II, Open-label Study of Efficacy and Safety of the Selective Inhibitor of Nuclear Export/SINE™ Compound KPT-330 (Selinexor) in Patients With Advanced Gynaecologic Malignancies

Karyopharm Therapeutics Inc·interventional·Posted Jan 1, 2014·Updated Jan 26, 2023

In Brief

A Phase 2 clinical trial evaluating Selinexor for Ovarian Carcinoma and 2 related conditions. Completed, enrolled 116 participants across 4 sites in 2 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOvarian Carcinoma, Endometrial Carcinoma, Cervical Carcinoma
CountriesBelgium, Denmark
Collaborators--

Timeline

Phase 2CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedJan 1, 2014
Enrollment StartApr 9, 2014
Primary CompletionJan 24, 2017
Study CompletionMar 29, 2017
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 12.5 years ago

Interventions

Selinexordrug

Route of administration and dosage form: Oral tablet; Doses: 35 mg/m\^2 BIW, 35 mg/m\^2 QW, 50 mg/m\^2 BIW, 50 mg/m\^2 QW, 60 mg/m\^2 BIW, 60 mg/m\^2 QW. Treatment cycles were 4 weeks each i.e., 28 day cycles.