drugset / Trial / NCT00179725

Phase I/II Open-Label, Dose Escalation Study To Determine The Maximum Tolerated Dose And To Evaluate The Safety Profile of Lenalidomide (Revlimid® CC-5013) With Liposomal Doxorubicin In Subjects With Advanced Ovarian and Primary Peritoneal Carcinoma

NCT00179725

Non-randomizedFactorialOpen-labelTreatment

Summary

Phase I will determine the MTD and evaluated the safety profile of oral lenalidomide on days 1-21 when given with liposomal doxorubicin on day 1 of every 28 day cycle Phase II will commence once the MTD is established, additional subjects will be enrolled and receive oral lenalidomide on days 1-21 with liposomal doxorubicinon day 1 in 28 day cycles until disease progression is documented.

Timeline

Start
2005-11
Primary completion
Completion
2007-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Doxorubicin Other / unclassified
Subject Lenalidomide Other / unclassified Oral

Indications