drugset / Trial / NCT01378091

Study of Lenalidomide and Docetaxel in Subjects With Androgen Independent Prostate Cancer

NCT01378091

Phase 1 Completed 64 enrolled Columbia University Celgene Corporation · collab
NaSingle-groupOpen-labelTreatment

Summary

Primary objectives: To determine the maximum tolerated doses (MTDs) of daily lenalidomide and docetaxel given every three weeks and prednisone, as combination therapy to subjects with androgen independent prostate cancer To evaluate the safety profile of the combination of daily lenalidomide and every three week docetaxel and prednisone when given to subjects with androgen independent prostate cancer Secondary objective: To explore the anti-tumor activity of the combination of daily lenalidomide and every 3 week docetaxel and prednisone when given to subjects with androgen independent prostate cancer.

Timeline

Start
2005-08
Primary completion
2013-09
Completion
2013-09

Drugs

EvaluationDrugModalityDoseRoute
Subject Docetaxel Small molecule 60 mg/m2
Subject Docetaxel Small molecule 75 mg/m2
Subject Lenalidomide Other / unclassified 10 mg
Subject Lenalidomide Other / unclassified 15 mg
Subject Lenalidomide Other / unclassified 20 mg
Subject Lenalidomide Other / unclassified 25 mg
Subject Lenalidomide Other / unclassified 30 mg
Subject Lenalidomide Other / unclassified 35 mg
Subject Lenalidomide Other / unclassified 40 mg
Subject Prednisone Other / unclassified 5 mg

Indications