Conditions: Prostate Cancer
Keywords: castrate-resistant prostate cancer prostate cancer Karyopharm KPT-330 selinexor
Allocation: RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 20
Healthy volunteers: no

Brief summary:
This is an open-label, Phase 2 clinical study of the oral Selective Inhibitor of Nuclear Export (SINE) selinexor (KPT-330) in patients with metastatic castration-resistant prostate cancer (mCRPC).

Detailed description:
This is a Phase 2, open-label study to explore the effect of selinexor (KPT-330) therapy in patients with metastatic castration-resistant prostate cancer (mCRPC). Approximately 50 patients are planned for enrollment. Patients will receive an oral dose of selinexor on one of three dosing schedules.

Arms:
arm 1: 80 mg twice weekly for 4 weeks (8 doses per 28-day cycle) arm 2: 80 mg once weekly for 4 weeks (4 doses per 28-day cycle) arm 3: 60 mg twice weekly for 2 weeks, then 1 week off (4 doses per 21-day cycle)

Interventions: intervention 1: Selinexor
Intervention descriptions: intervention 1: Comparison of different dosages and dosing schedules of drug.

Protocol document: