Study of Futibatinib for Patients with Advanced Cholangiocarcinoma with FGFR2 Fusions or Rearrangements

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What is this study about?

This clinical trial is focused on studying a type of cancer called advanced cholangiocarcinoma, which is a cancer that occurs in the bile ducts. The study is investigating a treatment using a medication called Futibatinib, also known by its code name TAS-120. This medication is taken as a film-coated tablet and is being tested at doses of 20 mg and 16 mg. The purpose of the study is to assess how effective Futibatinib is in providing clinical benefits to patients with this type of cancer, particularly those who have specific changes in their genes known as FGFR2 fusions or rearrangements.

Participants in the study will receive the medication orally, meaning it is taken by mouth. The study will observe how patients respond to the treatment over time, including any changes in their cancer and overall health. The trial will also monitor the safety of the medication by checking for any side effects or changes in health indicators such as laboratory test results and vital signs. The study aims to gather information on how long the treatment works, how it affects the progression of the cancer, and the overall survival of the patients.

Throughout the study, the effectiveness of the treatment will be evaluated by independent experts who will review the patients’ responses. The study will also consider the patients’ quality of life during the treatment, using questionnaires designed to measure their well-being. This trial is expected to continue until 2027, providing valuable insights into the potential benefits of Futibatinib for patients with advanced cholangiocarcinoma.

1 joining the study

Participation begins after meeting specific criteria, including confirmed diagnosis of advanced cholangiocarcinoma and evidence of FGFR2 gene fusions or rearrangements.

Previous treatment with a gemcitabine and platinum-based regimen is required, along with documentation of disease progression.

2 medication administration

The medication futibatinib is administered orally in the form of film-coated tablets.

Dosage options include 20 mg or 16 mg taken once daily (QD).

3 monitoring and assessments

Regular assessments are conducted to evaluate the response to treatment, including imaging studies to measure disease progression.

The primary goal is to determine the overall response rate (ORR), which includes partial or complete response to the treatment.

4 safety evaluations

Safety is monitored through the observation of adverse events (AEs), serious adverse events (SAEs), and any necessary dose modifications.

Additional evaluations include clinical laboratory tests, eye exams, and monitoring of vital signs.

5 quality of life assessments

Patient-reported outcomes (PROs) are measured using specific questionnaires to assess quality of life during the trial.

These assessments include the European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 and the EuroQol-5D (EQ-5D).

6 trial duration

The estimated end date for the trial is September 28, 2027.

The recruitment for the study began on June 1, 2023.

Who Can Join the Study?

The patient must have advanced cholangiocarcinoma, which is a type of cancer that affects the bile ducts.
The patient must have a confirmed diagnosis of cholangiocarcinoma that is either locally advanced, metastatic (spread to other parts of the body), or cannot be removed by surgery.
The patient must have documented evidence of FGFR2 gene fusions or other FGFR2 rearrangements. These are specific changes in the genes that can affect cancer growth.
The patient must have received at least one prior treatment that included gemcitabine and a platinum-based regimen. These are types of chemotherapy drugs used to treat cancer.
The patient must show evidence of disease progression, meaning the cancer has gotten worse, on their most recent therapy.
The patient must have measurable disease according to specific guidelines called Response Evaluation Criteria in Solid Tumors (RECIST).
The patient must have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) scale, which measures how well a patient can perform daily activities.
The patient must have adequate organ function, meaning their organs are working well enough to participate in the study.
The study is open to both male and female patients.
The study includes patients who are considered part of a vulnerable population, which means they may need extra protection or care.

Who Cannot Join the Study?

Patients who have a different type of cancer than advanced cholangiocarcinoma cannot participate. Cholangiocarcinoma is a type of cancer that starts in the bile ducts.
Patients who are not within the specified age range for the study cannot participate. The study is open to certain age groups only.
Patients who are not able to take the study medication as required cannot participate. The medication needs to be taken in specific doses.
Patients who are part of a vulnerable population that the study does not include cannot participate. Vulnerable populations may include groups like pregnant women or those with certain health conditions.
Patients who do not meet other specific health criteria set by the study cannot participate. These criteria ensure the safety and effectiveness of the study.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
IRCCS Humanitas Research Hospital	Rozzano	Italy
Hospital Universitario De Navarra	Pamplona	Spain
Unidade Local De Saúde De Santa Maria, E.P.E.	Lisbon	Portugal

Other Sites

Site Name	City	Country
Champalimaud Clinical Centre	Lisbon	Portugal
Hospital Universitario Fundacion Jimenez Diaz	Madrid	Spain
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie-Panstwowy Instytut Badawczy	Warsaw	Poland
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W Krakowie	Cracow	Poland
Centro Ricerche Cliniche Di Verona S.r.l.	Verona	Italy
Hospital General Universitario Gregorio Maranon	Madrid	Spain
Hospital Universitario 12 De Octubre	Madrid	Spain
Centrum Onkologii Ziemi Lubelskiej Im. Sw. Jana Z Dukli	Lublin	Poland
Europejskie Centrum Zdrowia Otwock Sp. z o.o.	Otwock	Poland
Amxvjfp Uvwjv Scovcayzx Lhqscy Dh Bhhgcnh	Bologna	Italy
Ibfzmpbz Cpudcm Dksooopyzirylmetr	L'hospitalet De Llobregat	Spain
Hiphrcez Vsae dwvjnobf	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
Italy	Recruiting	01.06.2023
Poland	Recruiting	01.06.2023
Portugal	Recruiting	01.06.2023
Spain	Recruiting	01.06.2023

Trial locations

Investigated drugs:

Futibatinib

Futibatinib is a medication being studied for its effectiveness in treating patients with advanced cholangiocarcinoma, a type of bile duct cancer. This medication targets specific genetic changes known as FGFR2 fusions or rearrangements, which are found in some cancer cells. The trial aims to determine how well futibatinib works in managing this condition.

Investigated diseases:

Cholangiocarcinoma

Advanced Cholangiocarcinoma – This is a type of cancer that originates in the bile ducts, which are the channels that carry bile from the liver to the small intestine. As the disease progresses, it can cause blockages in the bile ducts, leading to jaundice, abdominal pain, and liver dysfunction. The cancer cells can grow and spread to nearby tissues and organs, making it more challenging to manage. Over time, the tumor may invade blood vessels and lymph nodes, further complicating the condition. Symptoms often become more pronounced as the disease advances, affecting the patient’s quality of life.

Trial ID:

2023-503665-39-00

Protocol code:

TAS-120-205

NCT ID:

NCT05727176

Trial Phase:

Therapeutic exploratory (Phase II)

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Study of Futibatinib for Patients with Advanced Cholangiocarcinoma with FGFR2 Fusions or Rearrangements

What is this study about?

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