At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 54 enrolled
Drug / intervention
KCP-330drug
Likely dose
Not stated in 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.
An Open-Label Phase IB Trial To Evaluate the Effects of Food and Formulation on Pharmacokinetics of the Oral Selective Inhibitor of Nuclear Export/SINE Compound KPT-330 in Patients With Soft-Tissue or Bone Sarcoma
In Brief
A Phase 1 clinical trial evaluating KCP-330 for Sarcoma. Completed, enrolled 54 participants across 2 sites in 2 countries.
Detailed Summary
The purpose of this research study is to find out more information such as: to determine the effects of high and low fat foods on the pharmacokinetics (PK) of oral KPT-330 tablets and to compare PK of capsules and tablets in Arms 1 and 2; to evaluate tumor response in sarcoma participants in Arm 3; to compare the PK of 60 milligrams (mg) of the new, 2nd generation tablet formulation and 60 mg of the selinexor suspension formula to the current, 1st generation tablets.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSarcoma
CountriesCanada, United States
Collaborators--
Timeline
Phase 1CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedJul 2013
Enrollment StartJul 2013
Primary CompletionOct 2016
TodayJul 2026
First PostedJul 11, 2013
Enrollment StartJul 30, 2013
Primary CompletionOct 21, 2016
TodayJul 2, 2026
Enrollment to primary: 3.2 yearsPosted 13.0 years ago
Interventions
KCP-330drug