Ribociclib (LEE011) Rollover Study for Continued Access

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-15

Study Completion Date

2027-02-01

Brief Summary

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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.

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Detailed Description

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Conditions

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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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LEE011

All patients in all combinations with LEE011 will be entered in one arm.

Group Type EXPERIMENTAL

LEE011

Intervention Type DRUG

Single agent LEE011 or in combination with other treatments

Interventions

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LEE011

Single agent LEE011 or in combination with other treatments

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

0 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No