Spots Global Cancer Trial Database for CESAR Study in Prostate Cancer With Temsirolimus Added to Standard Docetaxel Therapy (CEPTAS)
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Trial Identification
Brief Title: CESAR Study in Prostate Cancer With Temsirolimus Added to Standard Docetaxel Therapy (CEPTAS)
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
Study ID: NCT01206036
Conditions
Study Description
Brief Summary: 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.
Detailed Description: 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.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: MALE
Healthy Volunteers: No
Locations
CESAR Study Center, Essen, , Germany
CESAR Study Center, Freiburg, , Germany
Contact Details
Name: Rudolf Morant, MD
Affiliation: Tumor-und Brustzentrum ZeTuP, St. Gallen, Switzerland
Role: STUDY_CHAIR
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