drugset / Trial / NCT01009346
RAD001 in Combination With Cetuximab and Cisplatin in Recurrent and Metastatic SCCHN
Phase 1/2
Terminated
9 enrolled
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Novartis Pharmaceuticals · collab
NaSingle-groupOpen-labelTreatment
Summary
1.Phase I: To estimate the Maximum Tolerated Dose (MTD) of RAD001 in combination with cetuximab and cisplatin for treatment of metastatic squamous cell cancer of the head and neck (SCCHN). Secondary Objectives 1.To assess the toxicity of RAD001 in combination with weekly cetuximab and cisplatin on days 1 and 8 of each 28 day cycle in patients with recurrent or metastatic SCCHN,
Timeline
- Start
- 2009-10
- Primary completion
- 2011-03
- Completion
- 2011-03
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Everolimus | Small molecule | 2.5 mg | Oral |
| Subject | Everolimus | Small molecule | 5 mg | Oral |
| Subject | Everolimus | Small molecule | 10 mg | Oral |
| Background | Carboplatin | Small molecule | — | — |
| Background | Cetuximab | Monoclonal antibody | 250 mg/m2 | Other |
| Background | Cisplatin | Other / unclassified | 40 mg/m2 | — |