Study on the Safety and Effectiveness of Afatinib for Fanconi Anemia Patients with Advanced Squamous Cell Carcinoma in the Oral Cavity, Oropharynx, Hypopharynx, or Larynx

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What is this study about?

This clinical trial is focused on studying the effects of a medication called Afatinib in patients with a rare genetic disorder known as Fanconi anemia. This disorder can lead to a type of cancer called squamous cell carcinoma, which affects areas such as the mouth, throat, and voice box. The study aims to understand how safe and effective Afatinib is when used to treat these cancers, especially when they cannot be surgically removed or have spread to other parts of the body.

The treatment involves taking Afatinib in the form of film-coated tablets, which are taken orally. The study will compare the effects of different doses of Afatinib to see how well it works in controlling the cancer and improving the quality of life for patients. Participants will be monitored for any side effects and how their cancer responds to the treatment over a period of time.

The purpose of this study is to gather information on the effectiveness of Afatinib in treating cancers associated with Fanconi anemia. The study will also look at how long the treatment effects last, the overall survival of patients, and any changes in their health-related quality of life. This information will help in understanding the potential benefits and risks of using Afatinib for this specific group of patients.

1 joining the study

Upon joining the study, the participant must provide written informed consent. This document confirms understanding and agreement to participate in the trial.

Eligibility is confirmed based on specific criteria, including age, health status, and previous treatments.

2 initial assessment

An initial assessment is conducted to evaluate the participant’s health status. This includes tests to confirm adequate organ and bone marrow function.

A performance status evaluation is performed to ensure the participant can carry out daily activities with minimal assistance.

3 treatment phase

The treatment involves taking GIOTRIF film-coated tablets, which contain the active substance afatinib. The tablets are taken orally.

The dosage of afatinib is determined by the healthcare provider, with available strengths of 40 mg, 30 mg, and 20 mg.

The frequency and duration of administration are specified by the healthcare provider, based on individual response and tolerance.

4 monitoring and follow-up

Regular monitoring is conducted to assess the treatment’s effectiveness and any side effects. This includes imaging tests like CT or MRI scans to measure tumor response.

Participants are evaluated for any adverse effects, and adjustments to the treatment plan may be made as necessary.

5 completion of treatment

Upon completion of the treatment phase, a final assessment is conducted to evaluate the overall response to the therapy.

Participants are advised on post-treatment care and any necessary follow-up appointments.

Who Can Join the Study?

The patient must provide written informed consent, which means they agree to participate in the study after understanding all the details.
The patient should have an ECOG performance status of less than 2. This is a scale used to assess how a patient’s disease affects their daily living abilities.
The patient must have adequate organ and bone marrow function, which includes:
- Neutrophils (a type of white blood cell) greater than 1000 cells per microliter.
- Platelets (cells that help with blood clotting) greater than 50,000 cells per microliter.
- Hemoglobin (a protein in red blood cells) greater than 8 grams per deciliter.
- Creatinine (a waste product in the blood) less than 1.5 times the upper limit of normal, with clearance greater than 50 milliliters per minute.
- Total bilirubin (a substance made during the breakdown of red blood cells) less than 1.5 times the upper limit of normal. Patients with Gilbert’s syndrome may have bilirubin less than 2 times the upper limit.
- AST and ALT (liver enzymes) less than 2.5 times the upper limit of normal, or less than 5 times if there are liver metastases.
- INR and PT (blood clotting tests) less than 1.5 times the upper limit of normal.
Female patients must either:
- Be of non-childbearing potential, which means they are postmenopausal (no menstrual periods for at least 1 year) or have had surgery to prevent pregnancy.
- If they can have children, they must agree not to become pregnant during the study and for at least 1 month after the last dose of the study drug. They must also have a negative pregnancy test before starting the study.
Female patients must agree not to breastfeed or donate eggs during the study and for at least 1 month after the last dose of the study drug.
Male patients must agree not to donate sperm during the study and for at least 1 month after the last dose of the study drug.
Male patients with partners who can become pregnant must agree to use a condom plus one form of highly effective birth control during the study and for at least 1 month after the last dose of the study drug.
The patient must agree not to participate in another interventional study while receiving treatment in this study.
The patient must be 18 years of age or older.
The patient must have a confirmed diagnosis of Fanconi anemia, a genetic disorder that affects the bone marrow.
The patient must have a confirmed diagnosis of unresectable or locoregionally advanced squamous cell carcinoma of certain areas like the oral cavity, oropharynx, hypopharynx, larynx, nasopharynx, paranasal sinuses, or salivary glands. This means the cancer cannot be removed by surgery or has spread to nearby areas.
The tumor must not be a candidate for surgical removal before the study drug due to technical reasons or low chances of surgical cure.
The patient should not be a candidate for other standard treatments like radiotherapy, chemotherapy, or immunotherapy that could cure the cancer.
The patient must have at least one measurable lesion, which is a tumor that can be measured using a CT or MRI scan.
Previous cancer treatments are allowed if they ended at least 6 weeks or 5 half-lives (whichever is shorter) before starting the study treatment.
Previous local treatments like radiotherapy are allowed.

Who Cannot Join the Study?

Patients who do not have a diagnosis of unresectable or metastatic locoregionally advanced squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, or larynx. Unresectable means the cancer cannot be removed with surgery. Metastatic means the cancer has spread to other parts of the body.
Patients who do not have Fanconi anemia, a rare genetic disorder that affects the bone marrow and can lead to cancer.
Patients who are not within the specified age range for the study.
Patients who are not part of the specified clinical trial groups.
Patients who are not male or female, as both genders are included in the study.
Patients who are not considered part of a vulnerable population, which may include groups like children or those with certain health conditions.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Medizinische Hochschule Hannover	Hanover	Germany

Other Sites

Site Name	City	Country	Status
Huwwjpvq Da Le Sdimj Cdbq I Sckl Pua	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
Germany	Recruiting	01.08.2024
Spain	Recruiting	01.08.2024

Trial locations

Investigated drugs:

Afatinib

Afatinib is a medication being studied for its effectiveness in treating patients with Fanconi anemia who have advanced squamous cell carcinoma in areas such as the oral cavity, oropharynx, hypopharynx, or larynx. This trial aims to determine how well Afatinib works in shrinking or controlling these types of cancers, especially when they cannot be surgically removed or have spread to other parts of the body.

Investigated diseases:

Fanconi Anemia – A rare genetic disorder that affects the bone marrow, leading to decreased production of all types of blood cells. It is characterized by physical abnormalities, bone marrow failure, and an increased risk of certain cancers. The disease progresses as the bone marrow becomes less effective at producing blood cells, leading to symptoms such as fatigue, frequent infections, and easy bruising. Over time, individuals with Fanconi anemia may develop leukemia or other cancers, particularly in the head and neck region. The condition is inherited in an autosomal recessive pattern, meaning both copies of the gene in each cell have mutations.

Squamous Cell Carcinoma of the Oral Cavity, Oropharynx, Hypopharynx, or Larynx – A type of cancer that arises from the squamous cells lining the oral cavity, oropharynx, hypopharynx, or larynx. It is characterized by the uncontrolled growth of abnormal cells in these areas, which can form tumors. As the disease progresses, it can invade nearby tissues and spread to other parts of the body. Symptoms may include a persistent sore throat, difficulty swallowing, changes in voice, and a lump in the neck. This type of cancer is often associated with risk factors such as tobacco use, alcohol consumption, and human papillomavirus (HPV) infection.

Trial ID:

2024-511477-29-00

Protocol code:

IRSSP-001

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on the Safety and Effectiveness of Afatinib for Fanconi Anemia Patients with Advanced Squamous Cell Carcinoma in the Oral Cavity, Oropharynx, Hypopharynx, or Larynx

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?