Active — Not RecruitingPhase 2

Ribociclib (LEE011) Rollover Study for Continued Access

United States22 participantsStarted 2016-12-15

Plain-language summary

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.

Who can participate

Age range0 Years – 80 Years

SexALL

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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.

What they're measuring

Number of Patients enrolled and received LEE011

Timeframe: up to 5 years (study duration)

Length of time receiving study treatment

Timeframe: up to 5 years (study duration)

Trial details

NCT IDNCT02934568

SponsorNovartis Pharmaceuticals

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-02-01

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