drugset / Trial / NCT01695473

Neoadjuvant BKM120 in High-risk Prostate Cancer

NCT01695473

Phase 2 Terminated 11 enrolled Won Kim Novartis · collab
NaSingle-groupOpen-labelTreatment

Summary

This is a phase II, study of BKM120 in patients with high-risk, localized prostate cancer. Eligible patients will be enrolled and scheduled to have an ultrasound-guided biopsy of the prostate to confirm high-risk disease and collect prostate tissue for analysis. Two weeks after the biopsy, patients will begin taking 100 mg/day of BKM120. BKM120 will be given at this dose level orally once daily for 14 days prior to radical prostatectomy at University of California, San Francisco. Radical prostatectomy will be performed on the day of the last dose of BKM120 at day 14. No further drug will be tken after the radical prostatectomy.

Timeline

Start
2013-04-23
Primary completion
2015-02-05
Completion
2015-02-05

Drugs

EvaluationDrugModalityDoseRoute
Subject Buparlisib Small molecule 100 mg Oral

Indications