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Ribociclib (LEE011) Rollover Study for Continued Access

Trial Status: Active

This study is to allow continued use of ribociclib (LEE011) as single agent or in combination with other investigational treatments in patients benefitting from treatment in an eligible Novartis-sponsored ribociclib (LEE011) study that has reached its primary objective(s) or has been halted for other reasons.

Inclusion Criteria

  • Patient is currently enrolled in an eligible Novartis-sponsored study and receiving ribociclib (LEE011) as single agent or in combination with other investigational treatment.
  • Patient is currently deriving clinical benefit from the study treatment, as determined by the investigator.

Exclusion Criteria

  • Patient has been permanently discontinued from ribociclib (LEE011) in the parent protocol for any reason.
  • Patients who do not meet parent protocol criteria to continue study treatment.

Alabama

Birmingham
University of Alabama at Birmingham Cancer Center
Status: CLOSED_TO_ACCRUAL

Michigan

Ann Arbor
University of Michigan Comprehensive Cancer Center
Status: COMPLETED

New York

Bronx
Montefiore Medical Center-Weiler Hospital
Status: ACTIVE

Tennessee

Memphis
Saint Jude Children's Research Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Giles W. Robinson
Phone: 901-595-2907

Trial Phase Phase II

Trial Type Treatment

Lead Organization
Novartis Pharmaceuticals Corporation

  • Primary ID CLEE011X2X01B
  • Secondary IDs NCI-2017-00789
  • Clinicaltrials.gov ID NCT02934568