Ribociclib (LEE011) Rollover Study for Continued Access

Description

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.

Study Start Date

December, 15 2016

Estimated Completion Date

April 2022

Interventions

  • Drug: LEE011

Study ID

Novartis -- CLEE011X2X01B

Status

Recruiting

Trial ID

NCT02934568

Study Type

Interventional

Trial Phase

Phase 2

Enrollment Quota

40

Sponsor

Novartis

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.

Gender

All

Ages

N/A

Accepts Healthy Volunteers

No

Study Locations and Contact Information (4)

Study Location Distance Name Phone Email
Dana Farber Cancer Institute Main Site - Boston, Massachusetts 2.4 miles Natasha Isaac None Nisaac1@partners.org
St Jude Childrens Research Hospital - Memphis, Tennessee 1,134.7 miles Kate Lyons None Kate.Lyons@StJude.org
St Jude Childrens Research Hospital - Memphis, Tennessee 1,134.7 miles Kate Lyons None Kate.Lyons@StJude.org
St Jude Childrens Research Hospital - Memphis, Tennessee 1,134.7 miles Kate Lyons None Kate.Lyons@StJude.org

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