At a glance

ClinicalIndex Comparison Record

Phase 2Completed· 10 enrolled

Drug / intervention

Selinexordrug

Likely dose

Selinexor 60 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/NCT02402764

NCT02402764Phase 2Completed

Compare CT.gov

Investigator-Initiated Phase 2 Clinical Trial of Selinexor (KPT-330) for the Treatment of Metastatic Triple Negative Breast Cancer

H. Lee Moffitt Cancer Center and Research Institute·interventional·Posted Mar 30, 2015·Updated Sep 11, 2020

In Brief

A Phase 2 clinical trial evaluating Selinexor for Breast Cancer. Completed, enrolled 10 participants across 1 site.

Detailed Summary

The main purpose of this study is to see whether the combination of selinexor (KPT-330) can help people with triple negative breast cancer (TNBC). Researchers also want to study the safety and tolerability of Selinexor in TNBC patients.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsBreast Cancer

CountriesUnited States

CollaboratorsKaryopharm Therapeutics Inc

Timeline

Phase 2CompletedFinished

201520162017201820192020202120222023202420252026

First PostedMar 2015

Enrollment StartJul 2015

Primary CompletionMar 2016

Study CompletionJun 2019

TodayJul 2026

First PostedMar 30, 2015

Enrollment StartJul 8, 2015

Primary CompletionMar 10, 2016

Study CompletionJun 6, 2019

TodayJul 2, 2026

Enrollment to primary: 8 monthsPosted 11.3 years ago

Interventions

Selinexordrug

Participants will receive selinexor twice weekly on Monday/Wednesday, Tuesday/Thursday or Wednesday/Friday of Weeks 1, 2 and 3 of each 4-week cycle. Selinexor will not be taken during Week 4. One cycle is defined as 28 days or 6 doses. The starting dose for this trial is 60 mg (flat dose as long as their dose-based body surface area (BSA) analysis does not exceed 70 mg/m\^2).