Active not recruitingPHASE1INTERVENTIONAL

A Study of IDH305 in Patients With Advanced Malignancies That Harbor IDH1R132 Mutations

This study is looking into a new medicine, IDH305, for adult patients (18-100 years old) who have advanced cancers with a specific gene change called IDH1R132. These types of cancer are sometimes called 'advanced malignancies that harbor IDH1R132 mutations'. The main goal is to find out if IDH305 is safe and what dose can be given without causing too many problems. It's also about seeing if the medicine helps slow down or stop the cancer from growing. This is an early stage study (Phase 1), which means it's one of the first times the medicine is being tested in people. Scientists hope this new treatment could offer another option for patients with these specific cancers.

At a glance

Status

Active not recruiting

Phase

PHASE1

Sponsor

Novartis Pharmaceuticals

Enrolment target

166

Start

06 Mar 2015

Estimated completion

31 Oct 2030

Advanced Malignancies That Harbor IDHR132 Mutations

What is this study about?

This research study is focused on a new medicine called IDH305. It's being tested in people who have advanced cancer that has a specific genetic change, or 'mutation', called IDH1R132. Our bodies are made of tiny building blocks called cells, and inside these cells are genes. Sometimes, a gene can change in a way that makes cells grow abnormally, leading to cancer. The IDH1R132 mutation is one such change.

IDH305 is designed to target this specific IDH1R132 mutation. The idea is that by targeting this particular change, the medicine might be able to stop or slow down the cancer cells from growing, while leaving healthy cells alone as much as possible. This is an early-stage study, meaning it's one of the first times this medicine is being given to people. The main goals are to make sure the medicine is safe and to find the right amount (dose) that can be given effectively.

Even though it's an early study, learning how new medicines like IDH305 work is very important. It helps scientists understand how these specific types of cancer behave and could lead to new treatments in the future. For patients with advanced cancers that have this IDH1R132 mutation, this study might offer a chance to try a new approach to managing their illness.

Key takeaways

This study tests a new medicine (IDH305) for advanced cancers with a specific gene change (IDH1R132).
It's an early-stage study (Phase 1) focused on safety and finding the right dose.
Patients must have the IDH1R132 gene change and be well enough to take part.
You will be closely monitored for effects of the medicine.
Participation is voluntary, and you can withdraw at any time.

Who may be eligible?

This study is looking for both men and women, aged 18 to 100 years old. To be considered, your doctors must have found that your cancer has the specific IDH1R132 gene change. Also, you need to be well enough to take part, meaning your daily activities aren't too limited by your health condition.

There are some reasons why you might not be able to join. For example, if you've already had a different medicine that specifically targets the IDH1 gene mutation (unless you have a certain type of brain tumour called glioma), you won't be able to take part. Also, if you have other serious health problems with your heart, lungs, stomach, kidneys, liver, or brain that might make taking part unsafe, you might not be eligible.

Pregnant or breastfeeding women cannot join the study, and people with a specific type of blood cancer called Acute Promyelocytic Leukemia also cannot participate. The study team will need to check your full medical history to make sure it's safe and appropriate for you 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 18 years old or older?
Has your doctor confirmed your cancer has the IDH1R132 gene change?
Are you able to manage most of your daily activities without too much difficulty?
Have you NOT previously taken a medicine specifically targeting the IDH1 gene (unless it was for a glioma)?
Are you NOT pregnant or breastfeeding?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will be given the new medicine, IDH305. The exact details of participation, like how often you'll need to visit the clinic, what tests you'll have, and how long the treatment might last, will be fully explained by the study team. Typically, in early-stage studies like this, patients will have regular appointments for check-ups, blood tests, and scans to see how the medicine is working and to monitor for any side effects. You will be closely monitored throughout your time in the study. You will also have follow-up visits after you stop taking the medicine to make sure you are doing well.

Potential risks and benefits

Patients who join this study might experience benefits such as having access to a new medicine not yet available to everyone, which could potentially help slow down or stop their cancer. However, it's also important to understand that this is an experimental medicine, and there's no guarantee it will work for everyone. Like all medicines, IDH305 could have side effects, which might be mild or more serious; the study team will monitor you closely for these and explain what to look out for. Remember, participation is completely voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (16)

Dana Farber Cancer Institute SC (1)
Verified postcode
Boston, United States
Dana Farber Cancer Institute
Verified postcode
Boston, United States
Columbia University Medical Center- New York Presbyterian Onc Dept.
Verified postcode
New York, United States
Columbia University Medical Center
Verified postcode
New York, United States
Uni Of TX MD Anderson Cancer Cntr
Verified postcode
Houston, United States
Novartis Investigative Site
Verified postcode
Melbourne, Australia
Novartis Investigative Site
Verified postcode
Parkville, Australia
Novartis Investigative Site
Verified postcode
Leuven, Belgium
Novartis Investigative Site
Verified postcode
Toronto, Canada
Novartis Investigative Site
Verified postcode
Cologne, Germany
Novartis Investigative Site
Verified postcode
Jena, Germany
Novartis Investigative Site
Verified postcode
Heidelberg, Germany

Common questions

What is an IDH1R132 mutation?

It's a specific change in a gene within your cancer cells. This change can make the cancer grow differently.

What does 'advanced malignancies' mean?

This means your cancer has either spread from where it started or cannot be cured by standard treatments.

What does Phase 1 mean for a study?

Phase 1 is an early stage of testing. It mainly checks if a new medicine is safe and helps find the best dose, rather than focusing fully on how well it works.

Will I get paid to be in this study?

Generally, patients are not paid to participate in clinical trials. However, some studies might cover travel costs or other expenses related to your visits.

Who can I talk to if I'm interested or have more questions?

You should talk to your cancer doctor or specialist. They can help you understand if this study or similar ones might be suitable for you.