drugset / Trial / NCT01510119
Autophagy Inhibition to Augment Mammilian Target of Rapamycin (mTOR) Inhibition: A Phase I/II Trial of RAD001 and Hydroxychloroquine (HCQ) in Patients With Previously Treated Renal Cell Carcinoma
Phase 1/2
Completed
40 enrolled
Abramson Cancer Center at Penn Medicine
Rutgers Cancer Institute of New Jersey · collabUniversity of Pittsburgh · collab
Non-randomizedSingle-groupOpen-labelTreatment
Summary
This is an open labeled phase I dose escalation study of hydroxychloroquine (HCQ) and RAD001 in patients with advanced renal cell carcinoma followed by a Phase II trial of RAD001 with HCQ. The target population are patients with one to three prior treatments for advanced renal cell carcinoma. In the phase I portion a traditional 3+3 design will be used to determine the maximal tolerated dose and/or recommended phase II dose for HCQ in combination with RAD001 po 10 mg/day.
Timeline
- Start
- 2011-09
- Primary completion
- 2016-04-04
- Completion
- 2017-01-05
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Everolimus | Small molecule | 10 mg | Oral |
| Subject | Hydroxychloroquine | Small molecule | 400 mg | Oral |
| Subject | Hydroxychloroquine | Small molecule | 600 mg | Oral |