Prostatic Neoplasms Clinical Trial
Official title:
Phase I/II Study With Temsirolimus Versus no add-on in Patients With Castration Resistant Prostate Cancer (CRPC) Receiving First-line Docetaxel Chemotherapy
In this Phase I study safety of the combination of Docetaxel and Temsirolimus needs to be shown before the study can be expanded into a Phase II study to examine the activity of a safe combination of Temsirolimus and Docetaxel in a comparison with Docetaxel alone.
The purpose of this Phase I study is to evaluate feasibility of dose levels DL1, DL2 and DL3
(which are combinations of Temsirolimus and Docetaxel) and defining a recommended dose (RD)
for the Phase II part using these dose levels in a dose escalating scheme.
Secondary objectives are the collection of safety data on the dose levels used in this part.
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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