Clinical Trials Directory

Trials / Completed

CompletedNCT02402764

Phase 2 Trial of Selinexor (KPT-330) for Metastatic Triple Negative Breast Cancer (TNBC)

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

Status
Completed
Phase
Phase 2
Study type
Interventional
Enrollment
10 (actual)
Sponsor
H. Lee Moffitt Cancer Center and Research Institute · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DRUGSelinexorParticipants 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).

Timeline

Start date
2015-07-08
Primary completion
2016-03-10
Completion
2019-06-06
First posted
2015-03-30
Last updated
2020-09-11
Results posted
2017-03-30

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT02402764. Inclusion in this directory is not an endorsement.