Ribociclib (LEE011) Rollover Study for Continued Access

Sponsor: Novartis Pharmaceuticals

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT02934568

Patient View

This study provides continued access to ribociclib for patients benefiting from previous Novartis trials. Eligible participants must be currently enrolled and showing clinical benefit. Exclusions include those permanently discontinued from ribociclib. The intervention involves ribociclib as a single agent or combined with other treatments.

Patient Parameters

Program Overview

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 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.

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