Active not recruitingPHASE4INTERVENTIONAL

Roll-over Study to Allow Access to Certinib (LDK378) for Patients Who Are on Ceritinib Treatment in a Novartis-sponsored Study

This study is designed to allow patients with specific cancers called ALK-positive malignancies to continue receiving a treatment called ceritinib. It's specifically for those who are already taking ceritinib as part of an earlier Novartis-sponsored study and whose doctors believe they are still benefiting from the medication. The main aim is to provide continued access to a treatment that is working for them, rather than testing a new drug or finding new uses for an existing one. Participants must meet certain health and safety requirements and be able to attend study visits, ensuring they can safely keep taking ceritinib under medical supervision.

At a glance

Status

Active not recruiting

Phase

PHASE4

Sponsor

Novartis Pharmaceuticals

Enrolment target

233

Start

11 Dec 2015

Estimated completion

09 Jun 2027

ALK Positive Malignancies

What is this study about?

This study is like a 'rollover' plan for patients who are already receiving a cancer medicine called ceritinib. Imagine you're in a research study and the medicine is working for you. This 'rollover' study makes sure you can keep getting that medicine even after the first study finishes its main part.

The medicine, ceritinib, targets a specific type of cancer known as ALK-positive malignancy. This means your cancer has a particular change (a mutation) that ceritinib is designed to treat. The purpose of this study is not to find out if ceritinib works – that's already being looked at in other studies. Instead, it's about providing ongoing access to the drug for those who are already on it and benefiting.

So, if you're currently in a Novartis study taking ceritinib and it's helping you, this new study allows you to continue that treatment. It ensures continuity of care, so you don't have to stop a medicine that your doctor believes is effective for you.

Key takeaways

This study offers continued ceritinib treatment for a specific cancer.
It's for those already in a Novartis study and benefiting from ceritinib.
Your doctor must agree that continued treatment is best for you.
Regular check-ups and monitoring are part of the study.
You can stop participating at any time if you wish.

Who may be eligible?

This study is for people who are currently taking ceritinib as part of another Novartis research study. Your doctor must believe that you are still benefiting from this treatment and that it's safe for you to continue. You also need to have followed the rules of your previous study carefully.

There are certain situations that would prevent you from joining. For example, if you had to stop ceritinib in your previous study because of side effects or if you currently have side effects that haven't cleared up. Pregnant or breastfeeding women cannot participate. Women who could become pregnant must use very reliable birth control during the study and for three months afterwards. Men must use condoms during the study and for three months after stopping the treatment, and should not father a child during this time.

Everyone joining needs to be able to come to all scheduled appointments and follow the study instructions. You'll also need to provide your written consent, which means you understand and agree to take part.

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.

Are you currently taking ceritinib in a Novartis study?
Does your doctor think you're still benefiting from ceritinib?
Have you consistently followed the rules of your previous study?
Are you able to attend all planned hospital visits and appointments?
Are you or your partner using effective contraception if applicable?

Answer every question to see your result.

What does participation involve?

If you join this study, you will continue to receive the ceritinib medication you are already taking. You'll have regular hospital visits for check-ups, assessments, and to make sure the medication is still working well for you and that you're not experiencing any unexpected side effects. These visits will involve discussions with your doctors, physical examinations, and possibly blood tests or scans, similar to what you might be used to from your previous study. The study will continue for as long as you are benefiting from the treatment and wish to continue, or until your doctor advises otherwise, or the study ends.

Potential risks and benefits

The main potential benefit of joining this study is the continued access to ceritinib, which your doctor believes is helping to manage your ALK-positive malignancy. This means you wouldn't have to interrupt a treatment that is currently working for you. As with any medication, there are potential risks and side effects associated with ceritinib; these will be discussed in detail by your doctor. You will have full access to study staff for any concerns. It's important to remember that you can decide to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (71)

Highlands Oncology Group
Verified postcode
Fayetteville, United States
Loma Linda University
Verified postcode
Loma Linda, United States
University of Colorado Cancer Center
Verified postcode
Aurora, United States
Maryland Oncology Hematology P A
Verified postcode
Rockville, United States
Essex Oncology of North Jersey PA
Verified postcode
Belleville, United States
Novartis Investigative Site
Verified postcode
Melbourne, Australia
Novartis Investigative Site
City only
Auckland, Australia
Novartis Investigative Site
Verified postcode
Leuven, Belgium
Novartis Investigative Site
Verified postcode
Natal, Brazil
Novartis Investigative Site
Verified postcode
Porto Alegre, Brazil
Novartis Investigative Site
Verified postcode
Barretos, Brazil
Novartis Investigative Site
Verified postcode
São Paulo, Brazil

Common questions

What is ALK-positive malignancy?

It's a type of cancer that has a specific genetic change (or mutation) that can sometimes be targeted by certain medicines like ceritinib.

Why is this called a 'rollover' study?

It's a study that allows you to 'roll over' from one research study to another to continue receiving a specific treatment you're already on and benefiting from.

Will I have to pay for the medication?

No, the study medication (ceritinib) will be provided to you at no cost as part of your participation.

What if I experience side effects?

Any side effects you experience will be carefully monitored by the study team, and they will provide guidance and care as needed. It's important to report any new symptoms immediately.

How long will I be on this study?

The duration of your participation will depend on how you respond to the treatment and your doctor's assessment, similar to how long you might take any ongoing medication.