drugset / Trial / NCT01182168
Gemcitabine and Split-Dose Cisplatin Plus Everolimus (RAD001) in Patients With Advanced Solid Tumor Malignancies
Phase 1
Completed
12 enrolled
Memorial Sloan Kettering Cancer Center
Novartis Pharmaceuticals · collab
NaSingle-groupOpen-labelTreatment
Summary
The purpose of this study is to test the safety of gemcitabine and cisplatin plus Everolimus (also called RAD001) at different dose levels. We want to find out what effects, good and/or bad, this treatment has on you and your cancer. Gemcitabine and cisplatin are standard chemotherapy drugs that are commonly used to treat advanced urothelial cancer. Everolimus is a pill that works by shutting down some of the pathways in cancer cells that make tumors grow. Laboratory studies have shown that Everolimus appears to improve the activity of cisplatin against cancer cells.
Timeline
- Start
- 2010-08
- Primary completion
- 2016-03
- Completion
- 2016-03
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Everolimus | Small molecule | 5 mg | Oral |
| Subject | Everolimus | Small molecule | 10 mg | Oral |
| Background | Cisplatin | Other / unclassified | — | Intravenous |
| Background | Gemcitabine | Small molecule | — | Intravenous |