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Ribociclib (LEE011) Rollover Study for Continued Access

Active Not RecruitingPhase 2

Sponsor: Novartis Pharmaceuticals

Conditions: Continued Access to Study Treatment(s), Cancers With a Mass, Bulky Tumor, Nodule, Lump, Advanced Cancer, Advanced Solid Tumors, Advanced Solid Malignancies

Interventions: LEE011

Countries: United States, France, Germany, Singapore, Spain, Taiwan

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.

Eligibility overview

Sex: ALL

Age: 0 Years to 80 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Locations (13)

Birmingham, Alabama, United States
Boston, Massachusetts, United States
Ann Arbor, Michigan, United States
Johnson City, New York, United States
Memphis, Tennessee, United States
Lyon, France
Villejuif, France
Cologne, North Rhine-Westphalia, Germany
Singapore, Singapore
Madrid, Spain
Madrid, Spain
Tainan, Taiwan
Taipei, Taiwan