Not recruiting

Study for Patients with Advanced Cancer Continuing Ribociclib Treatment

Verified siteRegistered drugNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial focuses on patients with different types of advanced cancer. The study involves a treatment called ribociclib, also known by its code name LEE011. Ribociclib is a medication that comes in the form of a hard capsule or a film-coated tablet and is taken orally. The purpose of this study is to allow patients who have previously participated in a Novartis-sponsored study with ribociclib to continue receiving the treatment if they are still benefiting from it, either as a single agent or in combination with other investigational treatments.

Participants in this study will continue to receive ribociclib as part of their treatment plan. The study is designed to monitor the number of patients receiving ribociclib and the duration of their exposure to the medication. Additionally, the study will observe the frequency and nature of any adverse events, which are unexpected medical problems that occur during treatment, as well as serious adverse events and liver function tests. This ongoing monitoring helps ensure the safety and effectiveness of the treatment for patients who are benefiting from it.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Enrollment in the rollover study
Participation begins after enrollment in a previous Novartis-sponsored study involving ribociclib (LEE011).
Eligibility requires current enrollment in an eligible study, receiving ribociclib as a single agent or in combination with other treatments, and deriving clinical benefit as determined by the investigator.
Step 2
Continuation of treatment
Continue receiving ribociclib in the form of a hard capsule or film-coated tablet.
The medication is taken orally, following the dosage and frequency prescribed by the healthcare provider.
Step 3
Monitoring and assessments
Regular monitoring for adverse events, including serious adverse events and liver function tests, is conducted.
The healthcare team assesses the frequency and nature of any adverse events experienced during the study.
Step 4
Duration of participation
Participation continues as long as clinical benefit is derived from the treatment, or until the study reaches its primary objectives or is terminated for other reasons.
The estimated end date for the study is September 1, 2026.

Who can join the trial?

7 criteria

The patient must be currently enrolled in a Novartis-sponsored study involving **ribociclib** (also known as LEE011). This means they are already part of a study using this specific medication.
The patient must be receiving **ribociclib** either by itself or together with other experimental treatments.
The patient must be experiencing a **clinical benefit** from the study treatment. This means the treatment is helping them, as judged by the doctor in charge of the study.
The patient must have shown they can follow the study rules and requirements, as checked by the doctor in charge of the study.
Both male and female patients can participate.
The study includes patients from different age groups.
The study may include people who are considered part of a **vulnerable population**. This term refers to groups of people who might need special protection or care, like children or those with certain health conditions.

Who cannot join the trial?

6 criteria

Patients who have not been part of a previous study involving the drug ribociclib (LEE011) cannot participate.
Patients who do not have advanced cancer are not eligible.
Patients who are not able to continue the treatment from the previous study for any reason cannot join.
Patients who are not within the specified age range for the study are excluded.
Patients who are not able to follow the study procedures or instructions cannot participate.
Patients who have any other medical condition that might interfere with the study treatment are not eligible.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Hospital Universitario 12 De Octubre
Verified
Madrid, Spain
University Hospital Cologne
Verified
Cologne, Germany

Trial locations

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Investigated drugs

Ribociclib: This medication is used in the trial to help treat certain types of cancer. It works by blocking proteins that promote the growth of cancer cells. Patients who have been benefiting from this treatment in previous studies are allowed to continue using it in this trial.

What is already known about the treatment

Ribociclib – Ribociclib is administered orally in tablet form and is used in the treatment of various advanced cancers. It is currently recognized in medical literature as a targeted cancer therapy, often used in combination with other treatments. The main therapeutic indication for ribociclib is to inhibit cancer cell growth in patients with advanced cancer types. At the molecular level, ribociclib works by inhibiting cyclin-dependent kinases 4 and 6 (CDK4/6), which are proteins that promote cell division. It is classified pharmacologically as a CDK4/6 inhibitor.

Investigated diseases

Advanced Cancer – Advanced cancer refers to cancer that has spread from its original site to other parts of the body. It is characterized by the growth of cancer cells that invade nearby tissues and organs. As the disease progresses, it can affect various bodily functions and lead to symptoms such as pain, fatigue, and weight loss. The progression of advanced cancer varies depending on the type of cancer and the organs involved. It often requires complex management to address the symptoms and maintain quality of life.