Safety Study of the Selective Inhibitor of Nuclear Export (SINE) KPT-330 in Patients With Advanced Hematological Cancer

Official Title

A Phase I Study of the Safety, Pharmacokinetics and Pharmacodynamics of Escalating Doses of the Selective Inhibitor of Nuclear Export/SINE™ Compound KPT-330 in Patients With Advanced Hematological Malignancies

Summary:

The purpose of this research study is to find out more information relating to the highest dose of KCP-330 that can be given safely and side effects it may cause, to examine how the body affects KCP-330 concentrations in the blood (pharmacokinetics or PK), to examine the effects of KCP-330 on the body (pharmacodynamics or PDn) and to obtain information on its effectiveness in treating cancer.

Trial Description

Primary Outcome:

• Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)
• Recommended Phase 2 Dose (RP2D) of Selinexor

• Maximum Observed Plasma Concentration (Cmax) of Selinexor
• Time to Maximum Observed Concentration (Tmax) of Selinexor
• Average Concentration From Time 0 to 24 Hours (Cavg0-24h) of Selinexor
• Area Under the Concentration-Time Curve From Time 0 to t (AUC0-t) of Selinexor
• Area Under the Concentration-Time Curve From Time 0 Extrapolated to Infinity (AUC0-inf) of Selinexor
• Apparent Volume of Distribution Uncorrected for Fraction Absorbed (Vd/F) of Selinexor
• Apparent Total Body Clearance, Uncorrected for Fraction Absorbed (Cl/F) of Selinexor
• Terminal Half-Life (t½) of Selinexor
• Number of Participants With Overall Response of Selinexor
• Duration of Response
• Progression-free Survival
• Duration of at Least Stable Disease
• Overall Survival

View this trial on ClinicalTrials.gov