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

Part of paid clinical trials in Ann Arbor, Michigan.

Sponsor
Ronald Buckanovich
Study ID
NCT03056833
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

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

Study Details

Investigators hypothesize that concurrent ribociclib treatment and chemotherapy will enhance the response to platinum-based therapy and maintenance therapy will slow ovarian cancer tumor growth leading to prolongation in progression free survival.

Key Dates

Start date
Jun 10, 2017
Status verified
Aug 2022
Primary completion
Jun 1, 2020
Completion
Aug 1, 2022

Study Design

Enrollment
35 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Ribociclib
    Ribociclib (LEE-011) will be used as concurrent therapy with platinum-based chemotherapy in platinum-sensitive recurrent ovarian cancer. Participants will receive 200, 400, or 600mg of ribociclib per day in combination with carboplatin + paclitaxel. Subjects will receive 6 cycles of carboplatin + paclitaxel given weekly with ribociclib.

Primary Outcome Measure

Maximal tolerated dose (MTD) of ribociclib (LEE-011) when given with carboplatin + paclitaxel in platinum-sensitive recurrent ovarian cancer [ Time Frame: 56 days ]

Locations (8)

FacilityCityStateZIPSite coordinators
University of Michigan Comprehensive Cancer CenterAnn ArborMichigan48109-
UPMC Hillman Cancer Center Upper St. ClairBethel ParkPennsylvania15102-
UPMC Hillman Cancer Center Arnold Palmer at Mountain ViewGreensburgPennsylvania15601-
UPMC Hillman Cancer Center Arnold Palmer Medical at NorwinIrwinPennsylvania15642-
UPMC Hillman Cancer Center Arnold Palmer at Mt PleasantMount PleasantPennsylvania15666-
University of Pittsburgh Medical CenterPittsburghPennsylvania15213-
UPMC Hillman Cancer Center Passavant (OHA)PittsburghPennsylvania15237-
UPMC Hillman Cancer Center WashingtonWashingtonPennsylvania15301-

Find similar trials in Ann Arbor, MI

By condition
Ovarian cancer
By specialty
OncologyGynecologic oncologyWomen's health
By research site
University of Michigan Comprehensive Cancer Center· Ann Arbor, MIUPMC Hillman Cancer Center Upper St. Clair· Bethel Park, PAUPMC Hillman Cancer Center Arnold Palmer at Mountain View· Greensburg, PAUPMC Hillman Cancer Center Arnold Palmer Medical at Norwin· Irwin, PAUPMC Hillman Cancer Center Arnold Palmer at Mt Pleasant· Mount Pleasant, PAUniversity of Pittsburgh Medical Center· Pittsburgh, PA

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