Everolimus (RAD001) in Combination With Intravenous Carboplatin in Taxane- and Anthracycline-pretreated Patients With Progressive Metastatic Breast Cancer
During the phase I part the study will include at least 3 patients at each dose-level until
MTD is reached. Each cohort will consist of newly enrolled patients. Intra-patient dose
escalation is not permitted. Once MTD is reached a total of 6 patients will be treated at
MTD (phase I). For the phase II the minimax two-stage design will be applied. After testing
the drug on 16 patients in the first stage of phase II, the trial will be terminated if 1 or
fewer respond (SD, PR, CR). If the trial goes on to the second stage, a total of 34 patients
will be studied during the phase II part.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Phase I: dose limiting toxicity
after three weeks
Yes
Germany: Federal Institute for Drugs and Medical Devices
CRAD001JDE15T
NCT00930475
February 2009
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