Overview

A Trial of Ribocilcib (LEE011) and Weekly Paclitaxel in Patients With Rb+ Advanced Breast Cancer

Status:
Active, not recruiting
Trial end date:
2022-04-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 1
Details
Lead Sponsor:
Abramson Cancer Center of the University of Pennsylvania
Treatments:
Albumin-Bound Paclitaxel
Paclitaxel