Welcome, this website is intended for international healthcare professionals with an interest in the treatment of Advanced Prostate Cancer. By clicking the link below you are declaring and confirming that you are a healthcare professional

You are here

Randomized phase II study of nintedanib in metastatic castration-resistant prostate cancer postdocetaxel

By Droz, J.-P., Medioni, J., Chevreau, C., De Mont-Serrat, H., Merger, M., Stopfer, P., Kaiser, R., Oudard and S.

Anticancer Drugs. 2014 May 20. [Epub ahead of print]


This open-label, phase II trial assessed the efficacy and safety of two doses of nintedanib, a triple angiokinase inhibitor targeting vascular endothelial growth factor, fibroblast growth factor, and platelet-derived growth factor signaling, in patients with metastatic castration-resistant prostate cancer (mCRPC) following progression on docetaxel-based regimens. Patients were randomized to nintedanib 150 mg (arm A, n=40) or 250 mg (arm B, n=41) twice daily for 6 months unless disease progression or adverse events (AEs) led to discontinuation. The primary endpoint was the prostate-specific antigen (PSA) response rate (confirmed PSA decline of ≥20% from baseline). Eighty-one patients were enrolled. The PSA response rate was 0% (0/32) in arm A versus 11.1% (4/36) in arm B (P=0.12); 5.6% of patients (2/36) in arm B showed a PSA reduction of at least 50%. In arm B, the rate of PSA increase was significantly decelerated on treatment versus before treatment (P=0.002). The median progression-free survival was 73.5 and 76.0 days for arm A and arm B, respectively (P=0.3). AEs included gastrointestinal disorders, asthenia, hypertension, and reversible elevated transaminases. The incidence of drug-related serious AEs (no drug-related deaths) was 20.0% (arm A) and 24.4% (arm B). The primary endpoint was not met. Nintedanib (250 mg) showed only modest activity with manageable AEs in patients with mCRPC post-docetaxel.



Register to be notified when new content is published. Only your name, country and email address needed.

Subscribe »

Latest webcast

ESMO 2016 Symposium webcast

Individualizing treatment in
metastatic prostate cancer: there
is no “one-size-fits-all” approach

EAU 2016 Scientific Programme and Sessions

View the Scientific Programme and Sessions of the 2016 EAU Annual Congress, Munich, Germany.

The editorial independence of the resource centre is mandatory and recognized by the EAU and Elsevier.
The journal articles, videos and statements published on the resource centre have been selected independently and without influence from Elsevier, European Urology Editors or the sponsor and do not necessarily reflect their opinions or views

Search this site

Search form