Active not recruitingPHASE2INTERVENTIONAL

Phase 2 Study Assessing Secured Access to Vemurafenib for Patients With Tumors Harboring BRAF Genomic Alterations

This research study is investigating a new use for a drug called vemurafenib. It's for adult patients with advanced cancers that have a specific genetic change in the BRAF gene (often called a 'BRAF V600 mutation'). These cancers include certain types of lung, ovarian, thyroid, prostate, and blood cancers, among others. Patients taking part in this study will have already tried standard treatments or have no other suitable options. The main goal is to find out how effective vemurafenib is at treating these cancers and to understand its side effects. This is a Phase 2 study, which means it builds on earlier research to gather more information about how well the drug works in a larger group of people.

At a glance

Status

Active not recruiting

Phase

PHASE2

Sponsor

UNICANCER

Enrolment target

216

Start

13 Oct 2014

Estimated completion

13 Oct 2027

Solid Tumors Hematologic Cancers Metastatic Cancers

What is this study about?

This study is looking at a specific cancer drug called vemurafenib. This drug works by targeting a particular change, or 'mutation,' in a gene called BRAF. When this BRAF gene is mutated (for example, a 'V600 mutation'), it can make cancer cells grow and spread. Vemurafenib is designed to block this faulty gene, which might help stop the cancer from growing.

The study is for adults whose cancer has spread or can't be removed by surgery, and who have tried standard treatments or don't have other suitable options. It includes various types of cancer, such as certain lung, ovarian, thyroid, prostate, and bladder cancers, as well as some blood cancers like multiple myeloma and chronic lymphocytic leukaemia. The researchers want to see if vemurafenib can shrink or control these cancers and to understand any side effects it might cause.

This is a 'Phase 2' trial, meaning it's a step in developing new treatments. It's designed to gather more information on how effective the drug is and to check its safety in a larger group of patients. The study also explores if this way of testing drugs (by looking at gene changes across different cancer types) can be done successfully in hospitals across France.

Key takeaways

Tests a drug called vemurafenib for suitability in various advanced cancers.
Focuses on cancers with a specific gene change (BRAF V600 mutation).
Aims to understand how well the drug works and its safety.
Patients must have limited or no other treatment options.
Participation involves regular monitoring and hospital visits.

Who may be eligible?

To join this study, you would generally need to be an adult (18 years or older) with advanced cancer that has either spread or can't be surgically removed. Importantly, your cancer must have a specific change in the BRAF gene, most commonly the 'V600 mutation.' You would also need to have tried other standard treatments that have stopped working, or there aren't any other suitable treatments available for your specific situation.

There are also specific requirements for different cancer types. For example, if you have Hairy Cell Leukaemia, you would need to have already received two other common treatments. Your cancer must also be measurable, meaning doctors can track its size and changes.

Before taking part, you would need to be well enough to join the study, and any side effects from previous cancer treatments should have mostly cleared up. The study does not include people with melanoma that has the V600 mutation, as vemurafenib is already a standard treatment for that.

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?
Do you have advanced cancer that has spread or can't be removed by surgery?
Has your doctor confirmed that your cancer has a specific 'BRAF V600 mutation'?
Have you already tried standard cancer treatments, or are there no other suitable options for your type of cancer?
Are you well enough, and have you recovered from any major side effects from previous treatments?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will receive the study drug, vemurafenib, as a single treatment. The research team will regularly monitor your health and how the drug is affecting your cancer. This will involve regular hospital visits, including physical examinations, blood tests, and scans (like CT scans) to check the cancer's size. The exact number and frequency of visits, as well as the total duration you might be on the study, will depend on how your cancer responds to the treatment. You will also have follow-up visits after you stop taking the study drug.

Potential risks and benefits

Potential benefits of joining this study could include receiving a treatment that might help control your cancer, especially if other treatments haven't worked or aren't available. You'd also be helping doctors learn more about cancer and contribute to developing new treatments for others. However, like all medications, vemurafenib can have side effects, which can vary from mild to more serious; the study will carefully monitor these. There is no guarantee that the treatment will work for you. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Tredaniel
Verified postcode
Paris, France

Common questions

What is a 'BRAF V600 mutation'?

It's a specific change in a gene called BRAF that can make cancer cells grow. Drugs like vemurafenib are designed to target this change.

What kind of cancers are included in this study?

This study is for several types of advanced cancers, including certain lung, ovarian, thyroid, prostate, bladder, blood cancers, and sarcomas, all with a BRAF V600 mutation.

What does 'Phase 2' mean for a trial?

Phase 2 trials test a drug in a larger group of patients to understand how well it works and to further check its safety, after initial safety tests.

Will I receive other cancer treatments during the study?

In this study, vemurafenib is given as a single treatment, meaning you won't typically receive other anti-cancer drugs at the same time.

Can I leave the study at any time?

Yes, you have the right to withdraw from the study at any point, and choosing to do so will not affect your future medical care.