drugset / Trial / NCT01259063
RAD001 and Intravesical Gemcitabine in BCG-Refractory Primary or Secondary Carcinoma In Situ of the Bladder
Phase 1/2
Completed
33 enrolled
Memorial Sloan Kettering Cancer Center
New York University · collabNovartis Pharmaceuticals · collabUniversity of Hawaii · collab
NaSingle-groupOpen-labelTreatment
Summary
The purpose of this study is to test the safety of gemcitabine applied to the bladder directly combined with different oral doses of everolimus and to assess the right doses. Gemcitabine will be given at a fixed dose. Up to 3 dose levels of everolimus will be evaluated. The purpose of the phase II part is to test the combination of gemcitabine applied to the bladder directly combined with different oral doses of everolimus and to study the effects of these two drugs together. The investigators want to find out what effects, good and/or bad, this treatment has on the patient and the cancer.
Timeline
- Start
- 2010-12
- Primary completion
- 2017-06
- Completion
- 2017-06
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Everolimus | Small molecule | 5 mg | Oral |
| Subject | Everolimus | Small molecule | 10 mg | Oral |
| Subject | Gemcitabine | Small molecule | 2000 mg | Other |