Ribociclib (LEE011) Rollover Study for Continued Access

An Open-label, Multi-center Rollover Protocol for Patients Who Have Participated in a Novartis-sponsored Ribociclib (LEE011) Study and Are Continuing to Benefit From Ribociclib as Single Agent or in Combination With Other Investigational Treatments

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02934568

Enrollment

Registered

2016-10-17

Start date

2016-12-15

Completion date

2027-02-01

Last updated

2026-04-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Ribociclib, LEE011

Brief 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.

Interventions

DRUGLEE011

Single agent LEE011 or in combination with other treatments

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

0 Years to 80 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Number of Patients enrolled and received LEE011	up to 5 years (study duration)	Continued access to study treatment as a single agent or in combination with other investigational treatments until patients discontinue study
Length of time receiving study treatment	up to 5 years (study duration)	Assessed by duration in days from start of study treatment until study treatment discontinuation

Secondary

Measure	Time frame	Description
Frequency and nature of adverse events (AEs), serious adverse events (SAEs), non-fatal SAEs and liver function assays.	up to 5 years (study duration)	The data include only AEs that started or worsened during the on-treatment-period, the treatment-emergent AEs.

Countries

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 17, 2026