Active, Not Recruiting

NCT Number: NCT02934568

Ribociclib (LEE011) Rollover Study for Continued Access

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

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

Age range

0 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Novartis Investigative Site, Lyon, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

LEE011

Drug

Single agent LEE011 or in combination with other treatments

Primary outcomes

Number of Patients enrolled and received LEE011

Time frame: 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

Time frame: up to 5 years (study duration)

Assessed by duration in days from start of study treatment until study treatment discontinuation

Secondary outcomes

Frequency and nature of adverse events (AEs), serious adverse events (SAEs), non-fatal SAEs and liver function assays.

Time frame: up to 5 years (study duration)

The data include only AEs that started or worsened during the on-treatment-period, the treatment-emergent AEs.

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

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

Important dates

Study start: 2016
Primary completion: 2027
Study completion: 2027
First posted: Oct 17, 2016
Registry last updated: Apr 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.