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drugset / Trial / NCT01094288

A Phase 1 Study of Alisertib Participants With Advanced Solid Tumors Including Castration-Resistant Prostate Cancer Receiving a Standard Docetaxel Regimen

NCT01094288 ↗

Phase 1 Completed 41 enrolled Millennium Pharmaceuticals, Inc.
NaSingle-groupOpen-labelTreatment

Summary

The purpose of this study is to evaluate the safety and tolerability of alisertib in combination with docetaxel as a treatment for participants with advanced solid tumors, including castration-resistant prostate cancer, who were deemed by the investigator to be medically appropriate candidates for docetaxel therapy.

Timeline

Start
2010-08-17
Primary completion
2014-02-28
Completion
2017-01-04

Drugs

EvaluationDrugModalityDoseRoute
Subject Alisertib Small molecule 10 mg Oral
Subject Alisertib Small molecule 40 mg Oral
Background Docetaxel Small molecule 60 mg/m2 Intravenous
Background Docetaxel Small molecule 75 mg/m2 Intravenous

Indications

prostate adenocarcinoma