drugset / Trial / NCT01576029

Continued Treatment With Docetaxel Versus Switch to Cabazitaxel After Minor Prostate Specific Antigen Response to Docetaxel in Patients With Castration-Resistant Metastatic Prostate Cancer

NCT01576029

Phase 2 Completed 2 enrolled Sanofi
RandomizedParallel-groupOpen-labelTreatment

Summary

Primary Objective: * To compare the continuation of treatment with docetaxel versus switching to cabazitaxel regarding the time to PSA (Prostatic Specific Antigen) progression (TTP-PSA), in patients with Castration-Resistant Prostate Cancer (CRPC) that, after four cycles of docetaxel, have minor PSA response (defined as a reduction between 1% and 49%) or increase of up to 24% in PSA levels. Secondary Objectives: * PSA response rate * Overall survival (OS) * Incidence of Adverse Events

Timeline

Start
2012-08
Primary completion
2013-12
Completion
2013-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Cabazitaxel Other / unclassified 25 mg/m2 Intravenous
Comparator Docetaxel Small molecule 75 mg/m2 Intravenous

Indications