drugset / Trial / NCT00179751
A Phase I/II Study of Lenalidomide in Combination With Gemcitabine in Patients With Untreated Advanced Carcinoma of the Pancreas
Non-randomizedFactorialOpen-labelTreatment
Summary
Phase I will determine the MDT and evaluate the safety profile of oral lenalidomide days 1-21 and weekly gemcitabine days 1, 8, \& 15 in 28 day cycles Phase II will explore the anti-tumor activity and safety of the combination in subjects with advanced pancreatic carcinoma. Subjects will receive oral lenalidomide days 1-21 and weekly gemcitabine days 1, 8, \& 15 in 28 day cycles until documented disease progression occurs.
Timeline
- Start
- 2005-04
- Primary completion
- —
- Completion
- 2006-08
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Gemcitabine | Small molecule | — | — |
| Subject | Lenalidomide | Other / unclassified | — | Oral |