Ribociclib (Ribociclib (LEE-011)) With Platinum-based Chemotherapy in Recurrent Platinum Sensitive Ovarian Cancer

PHASE1CompletedINTERVENTIONAL
Enrollment

35

Participants

Timeline

Start Date

June 10, 2017

Primary Completion Date

June 1, 2020

Study Completion Date

August 1, 2022

Conditions
Ovarian CancerFallopian Tube CancerPeritoneal Carcinoma
Interventions
DRUG

ribociclib

Ribociclib (LEE-011) will be given on days 1-4, 8-11, and 15-18 of a 28 day cycle at 200, 400, or 600mg/day during the dose escalation phase. During the maintenance phase, ribociclib (LEE-011) will be given at 600mg/day, 3 weeks on, 1 week off until progression.

DRUG

Paclitaxel

During the escalation phase Paclitaxel will be given on days 1, 8, and 15 of a 28 day cycle.

DRUG

Carboplatin

During the escalation phase Carboplatin will be given on days 1, 8, and 15 of a 28 day cycle.

Trial Locations (8)

15102

UPMC Hillman Cancer Center Upper St. Clair, Bethel Park

15213

University of Pittsburgh Medical Center, Pittsburgh

15237

UPMC Hillman Cancer Center Passavant (OHA), Pittsburgh

15301

UPMC Hillman Cancer Center Washington, Washington

15601

UPMC Hillman Cancer Center Arnold Palmer at Mountain View, Greensburg

15642

UPMC Hillman Cancer Center Arnold Palmer Medical at Norwin, Irwin

15666

UPMC Hillman Cancer Center Arnold Palmer at Mt Pleasant, Mount Pleasant

48109

University of Michigan Comprehensive Cancer Center, Ann Arbor

All Listed Sponsors
lead

Ronald Buckanovich

OTHER

NCT03056833 - Ribociclib (Ribociclib (LEE-011)) With Platinum-based Chemotherapy in Recurrent Platinum Sensitive Ovarian Cancer | Biotech Hunter | Biotech Hunter