All studies
Active not recruitingPHASE2INTERVENTIONAL

Ribociclib (LEE011) Rollover Study for Continued Access

This study is for people with advanced cancer who are already taking a specific cancer drug called ribociclib (also known as LEE011) as part of another Novartis research study. The main goal of this 'rollover' study is to allow these patients to continue receiving ribociclib if their doctor believes it is still helping them. This is typically done when the original study they were part of has finished its main purposes or has been stopped for other reasons. Participants can be of any age from 0 to 80 years old, and both males and females can take part, provided they meet specific criteria about their current treatment and its effectiveness.

At a glance

Status
Active not recruiting
Phase
PHASE2
Sponsor
Novartis Pharmaceuticals
Enrolment target
22
Start
15 Dec 2016
Estimated completion
01 Feb 2027

What is this study about?

Imagine you're already in a research study for a cancer medicine called ribociclib (also known as LEE011) and it’s really making a difference for you. Sometimes, these studies come to an end, even if the medicine is still working well for some people. This *new* study is designed specifically for those people.

It's called a 'rollover' study because it lets you 'roll over' from your original study into this one. This means you can keep getting the ribociclib treatment, either as a single medicine or along with other new medicines being tested, as long as your doctor thinks it's still benefiting you. It's a way to ensure continued access to a promising treatment if you're already responding well to it.

This study is important because it provides a bridge, allowing patients who are seeing good results from ribociclib to continue their treatment without interruption, even after their initial trial has concluded. It focuses on people with advanced cancers, making sure that if a treatment is working, access can be maintained.

Key takeaways

  • This study is about continuing your existing cancer treatment.
  • It's only for patients already taking ribociclib in another study.
  • You must be benefiting from ribociclib to join.
  • It allows continued access to the drug if your original study ends.
  • Regular health checks similar to your current study would continue.

Who may be eligible?

This study is for people who are currently in another Novartis study and are already receiving the medicine called ribociclib. Your doctor must believe that the treatment is helping you and that you are getting a clinical benefit from it. Both men and women between the ages of 0 and 80 years old can take part, as long as they meet these specific requirements.

However, you cannot join this study if you have already permanently stopped taking ribociclib in your original study for any reason. Also, if you no longer meet the original study's rules for continuing your treatment, you would not be able to join this rollover study. The core idea is that you must be currently taking and benefiting from ribociclib in another study.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

  1. Am I currently in a Novartis study, receiving ribociclib (LEE011)?
  2. Does my doctor believe I am currently benefiting from this treatment?
  3. Have I *not* permanently stopped taking ribociclib in my current study?
  4. Do I meet my current study's rules for continuing treatment?
  5. Am I between 0 and 80 years old?
Answer every question to see your result.

What does participation involve?

If you join this study, you will continue to receive the ribociclib treatment, just as you have been in your original study. This means you'll continue to have regular visits with your healthcare team, likely at your current clinic or hospital. During these visits, the team will check how you're feeling and how the treatment is working. They will conduct assessments, which might include blood tests, physical exams, and possibly scans, to monitor your health and the progress of your cancer. The specific schedule for these visits and tests will be similar to what you've already experienced. You will continue taking the ribociclib as prescribed, and your follow-up will continue for as long as your doctor believes the treatment is helping you and you meet the study's requirements.

Potential risks and benefits

The main benefit of joining this study is that you can continue to receive a treatment that your doctor believes is currently helping you, even if your original study has ended. This may help maintain the positive effects you've been experiencing. As with any medication, there are potential risks and side effects associated with ribociclib, which you will already be familiar with from your previous study. Your medical team will continue to monitor you closely for any unwanted effects. Remember, participating in any study is entirely voluntary, and you have the right to withdraw at any time without affecting your medical care.

Locations (13)

  • University Of Alabama At Birmingham
    Verified postcode
    Birmingham, United States
  • Dana Farber Cancer Institute
    Verified postcode
    Boston, United States
  • The Regents of the Uni of Michigan
    Verified postcode
    Ann Arbor, United States
  • Broome Oncology
    Verified postcode
    Johnson City, United States
  • St Jude Childrens Research Hospital
    Verified postcode
    Memphis, United States
  • Novartis Investigative Site
    Verified postcode
    Lyon, France
  • Novartis Investigative Site
    Verified postcode
    Villejuif, France
  • Novartis Investigative Site
    Verified postcode
    Cologne, Germany
  • Novartis Investigative Site
    Verified postcode
    Singapore, Singapore
  • Novartis Investigative Site
    Verified postcode
    Madrid, Spain
  • Novartis Investigative Site
    Verified postcode
    Madrid, Spain
  • Novartis Investigative Site
    Verified postcode
    Tainan, Taiwan

Common questions

What is ribociclib?

Ribociclib (also known as LEE011) is a medicine used to treat certain types of cancer.

Who is this study for?

It's for people already in another Novartis study, taking ribociclib, and benefiting from it.

Why is this study needed?

It allows patients whose current study is ending to keep getting a treatment that is working for them.

Can I join if I stopped taking ribociclib before?

No, you must currently be taking and benefiting from ribociclib in another study to join this one.

What is a 'rollover' study?

It means you 'move' from your original study to this new one to continue your current treatment.

How to find out more

Always speak to your GP or specialist before deciding to take part in a study.

Discussion

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