drugset / Trial / NCT02292550
Study of Safety and Efficacy of LEE011 and Ceritinib in Patients With ALK-positive Non-small Cell Lung Cancer.
Non-randomizedParallel-groupOpen-labelTreatment
Summary
This was a Phase Ib/II study of the ALK inhibitor ceritinib in combination with the CDK4/6 inhibitor LEE011 in patients with ALK-positive non-small cell lung cancer. The purpose of the study was to determine the MTD/RP2D of the LEE011 and ceritinib combination and evaluate whether the combination was safe and had beneficial effects in ALK-positive advanced non-small cell lung cancer patients. This trial did not progress to Phase II. Trial population terminated before reaching Phase II
Timeline
- Start
- 2015-05-14
- Primary completion
- 2018-09-26
- Completion
- 2018-09-26
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ceritinib | Small molecule | 300 mg | Oral |
| Subject | Ceritinib | Small molecule | 450 mg | Oral |
| Subject | Ribociclib | Small molecule | 100 mg | Oral |
| Subject | Ribociclib | Small molecule | 200 mg | Oral |
| Subject | Ribociclib | Small molecule | 300 mg | Oral |