Trials / Completed
CompletedNCT02599363
A Trial of Ribocilcib (LEE011) and Weekly Paclitaxel in Patients With Rb+ Advanced Breast Cancer
A Phase I Trial of Ribocilcib (LEE011) and Weekly Paclitaxel in Patients With Rb+ Advanced Breast Cancer
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 18 (actual)
- Sponsor
- Abramson Cancer Center at Penn Medicine · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Ribociclib (LEE011) | |
| DRUG | Paclitaxel |
Timeline
- Start date
- 2016-01-01
- Primary completion
- 2019-03-12
- Completion
- 2019-03-12
- First posted
- 2015-11-06
- Last updated
- 2023-11-09
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT02599363. Inclusion in this directory is not an endorsement.