RecruitingPHASE1, PHASE2INTERVENTIONAL

Afatinib in Patients With Fanconi Anemia (FA) and Advanced Head and Neck Squamous Cell Carcinoma (HNSCC)

This research study is looking at a drug called Afatinib for patients who have both Fanconi Anemia and a type of head and neck cancer that can't be removed by surgery or has spread. Fanconi Anemia is a rare, inherited blood disorder that can increase the risk of certain cancers, including head and neck cancer. Afatinib is a targeted cancer drug that aims to block signals that help cancer cells grow. The study, conducted in two early phases (Phase 1b and Phase 2), will check if Afatinib is safe to use in these patients and if it can help stop their cancer from growing or spreading. There's early evidence suggesting this drug could be helpful for this specific group of patients, and we want to find out more. Patients will receive Afatinib, and researchers will closely monitor their health and the cancer's response.

At a glance

Status

Recruiting

Phase

PHASE1, PHASE2

Sponsor

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Enrolment target

Start

08 Nov 2024

Estimated completion

01 Dec 2028

Fanconi Anemia Head and Neck Squamous Cell Carcinoma

What is this study about?

This research study is about a new way to treat a specific type of head and neck cancer in people who also have a rare condition called Fanconi Anemia. Fanconi Anemia is a genetic condition that affects how the body repairs damaged cells, and it can increase a person's risk of developing certain cancers, including head and neck cancer. Unfortunately, this type of cancer can sometimes be difficult to treat, especially if it has grown or spread.

The study will investigate a drug called Afatinib. This drug is known as a "targeted therapy" because it works by blocking specific signals that cancer cells need to grow and divide. Scientists have some early evidence from lab studies that suggests Afatinib might be helpful for people with Fanconi Anemia and head and neck cancer. The main goal of this study is to see if this drug is safe for these patients and if it can help control their cancer.

This study is being done in two early phases (Phase 1b and Phase 2). This means we're still learning about the drug's effects in this specific group of patients. During the study, all participants will receive the Afatinib treatment. Doctors will carefully monitor how patients react to the drug, check for any side effects, and see if the cancer shrinks or stops growing. The hope is to find a new and effective treatment option for these patients.

Key takeaways

This study is testing a specific drug, Afatinib, for head and neck cancer in people with Fanconi Anemia.
It's an early-stage study (Phase 1b/2) to understand safety and if the drug can control the cancer.
All participants will receive the Afatinib drug.
Regular clinic visits, blood tests, and scans will be part of the study to monitor your health.
Potential benefits include a new treatment option; potential risks include drug side effects.
You can withdraw from the study at any time without affecting your ongoing medical care.

Who may be eligible?

To join this study, you need to be at least 18 years old and have a confirmed diagnosis of Fanconi Anemia. You must also have head and neck cancer that doctors have determined cannot be removed by surgery or has spread to other parts of your body. The team will check if your cancer has spread by looking at scans like CT or MRI.

It’s important that your body is generally strong enough for the treatment. This means your blood counts (like red blood cells, white blood cells, and platelets) and the way your liver and kidneys are working should be within healthy ranges. You'll also need to be able to move around and do your daily activities with limited difficulty, as assessed by a quick performance check.

If you've had previous cancer treatments, that's usually okay, but there will be a waiting period to make sure any previous treatment has left your body before you start the study drug. For women, if you could still have children, you would need to be using effective birth control. The study team will review all these details with you to see if you are a good fit.

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 at least 18 years old?
Do you have a confirmed diagnosis of Fanconi Anemia?
Do you have head and neck cancer that can't be fully removed by surgery or has spread?
Are your general health, blood counts, and organ functions within healthy limits?
Are you able to visit the clinic regularly for check-ups and tests?

Answer every question to see your result.

What does participation involve?

If you decide to join this study, you will be given the drug Afatinib. You will have regular visits to the clinic so the doctors can closely monitor your health and how the treatment is working. These visits might include blood tests, physical examinations, and scans (like CT or MRI) to check on your cancer. The doctors will also be on the lookout for any side effects you might experience.

The study is designed to assess the safety and effectiveness of Afatinib over a period of time. You will continue to take the medication and have follow-up appointments as long as the treatment is helping you and you are not experiencing severe side effects. The total duration of your participation will depend on how you respond to the treatment and the study's monitoring schedule, but it typically involves ongoing monitoring for several months or longer.

Potential risks and benefits

Taking part in this study may offer a potential benefit if Afatinib helps to control your cancer, especially since current options for this specific condition might be limited. However, as with any medical treatment, there are potential risks and side effects. Afatinib can cause side effects, which the study team will monitor closely. These could include things like skin rashes, diarrhoea, or changes in how your liver or kidneys work. You will be given more detailed information about these potential side effects. It's important to remember that you are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (2)

Medizinische Hochschule Hannover
Verified postcode
Hanover, Germany· Recruiting
Hospital de la Santa Creu i Sant Pau
Verified postcode
Barcelona, Spain· Recruiting

Common questions

What is Fanconi Anemia, and why is it important for this study?

Fanconi Anemia is a rare, inherited condition that means your body has trouble fixing damaged cells, which can increase your risk of certain cancers, like head and neck cancer. This study specifically focuses on patients who have both Fanconi Anemia and head and neck cancer.

What is Afatinib, and how does it work?

Afatinib is a type of cancer drug called a 'targeted therapy.' It works by blocking specific signals that tell cancer cells to grow and multiply. By stopping these signals, it aims to slow down or stop the cancer from growing.

Will I definitely get the study drug if I join?

Yes, if you meet all the requirements for this study, you will receive the study drug Afatinib. This study is not comparing Afatinib to another drug or a placebo; everyone who joins will get the treatment.

How often will I need to visit the clinic?

You will need to have regular visits to the clinic for check-ups, blood tests, and scans to monitor your health and how the treatment is working. The exact schedule will be explained by the study team.

Can I stop participating in the study if I want to?

Yes, you can choose to leave the study at any time, for any reason, without it affecting your standard medical care. Your decision will be fully respected.

How to find out more

A Responsible Person Designated by the Sponsor

investigacion@mfar.net +34 93 434 44 12 Official trial record

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