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

Part of paid clinical trials in Philadelphia, Pennsylvania.

Sponsor
Abramson Cancer Center at Penn Medicine
Study ID
NCT02599363
Phase
PHASE1
Status
Completed

Conditions

  • Advanced Breast Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
Jan 31, 2016
Status verified
Nov 2023
Primary completion
Mar 12, 2019
Completion
Mar 12, 2019

Study Design

Enrollment
18 participants (actual)
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Dose Escalation Treatment Arm

Primary Outcome Measure

Number of Adverse Events [ Time Frame: 3 years ]

Locations (1)

FacilityCityStateZIPSite coordinators
Abramson Cancer Center of the University of PennsylvaniaPhiladelphiaPennsylvania19104-

Find similar trials in Philadelphia, PA

By research site
Abramson Cancer Center of the University of Pennsylvania· Philadelphia, PA

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