drugset / Trial / NCT02599363
A Trial of Ribocilcib (LEE011) and Weekly Paclitaxel in Patients With Rb+ Advanced Breast Cancer
NaSequentialOpen-labelTreatment
Summary
This is a Phase I study to assess the safety and Maximum tolerated dose (MTD) of paclitaxel + ribociclib (LEE011) in patients with Rb+, advanced breast cancer. Dose escalation will be performed using standard 3 + 3 dosing strategy. The starting dose of ribociclib (LEE011) is 200 mg once daily; dose escalation proceeds in 200 mg increments up to a maximum of 600 mg. Dose-limiting toxicities (DLT) will be based upon first-cycle toxicity.
Timeline
- Start
- 2016-01
- Primary completion
- 2019-03-12
- Completion
- 2019-03-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ribociclib | Small molecule | 200 mg | — |
| Subject | Ribociclib | Small molecule | 400 mg | — |
| Subject | Ribociclib | Small molecule | 600 mg | — |
| Background | Paclitaxel | Small molecule | — | — |