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CESAR Study in Prostate Cancer With Temsirolimus Added to Standard Docetaxel Therapy (CEPTAS)

NCT01206036 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2016-01-27

No results posted yet for this study

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.

Conditions

  • Prostatic Neoplasms

Interventions

DRUG

Docetaxel

DL 1: Docetaxel 60mg/m\^2, Temsirolimus 15mg. DL 2: Docetaxel 60mg/m\^2, Temsirolimus 25mg. DL 3: Docetaxel 75mg/m\^2, Temsirolimus 25mg. One cycle is defined as a 3 week period (21 days) where docetaxel is given on day 1, and temsirolimus on days 1, 8 and 15.

DRUG

Temsirolimus

DL 1: Docetaxel 60mg/m\^2, Temsirolimus 15mg. DL 2: Docetaxel 60mg/m\^2, Temsirolimus 25mg. DL 3: Docetaxel 75mg/m\^2, Temsirolimus 25mg. One cycle is defined as a 3 week period (21 days) where docetaxel is given on day 1, and temsirolimus on days 1, 8 and 15.

Sponsors & Collaborators

  • Central European Society for Anticancer Drug Research

    lead OTHER

Principal Investigators

  • Rudolf Morant, MD · Tumor-und Brustzentrum ZeTuP, St. Gallen, Switzerland

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-07-31
Primary Completion
2014-09-30
Completion
2015-10-31

Countries

  • Germany

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01206036 on ClinicalTrials.gov