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

Recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-511125-61-00

Acronym

CLEE011X2X01B

Enrollment

Registered

2024-04-17

Start date

2017-03-08

Completion date

Unknown

Last updated

2025-12-10

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

Conditions

Different types of advanced cancer

Brief summary

Number of patients receiving ribociclib as single agent or in combination with other investigational treatments under the rollover study, duration of exposure

Detailed description

Frequency and nature of adverse events (AEs), serious adverse events (SAE) and liver function tests

Interventions

DRUGLEE011

DRUGEGF816

Eligibility

Sex/Gender

All

Age

0 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Number of patients receiving ribociclib as single agent or in combination with other investigational treatments under the rollover study, duration of exposure	—

Secondary

Measure	Time frame
Frequency and nature of adverse events (AEs), serious adverse events (SAE) and liver function tests	—

Countries

Germany, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026