Study on the Effectiveness and Safety of Tinengotinib for Patients with Cholangiocarcinoma Resistant to Chemotherapy and FGFR Inhibitors

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What is this study about?

This clinical trial is focused on studying a type of cancer called cholangiocarcinoma, which affects the bile ducts. The study is testing a new treatment called tinengotinib, which is taken as a tablet. Tinengotinib is being compared to other treatments chosen by doctors for patients whose cancer has specific changes in the Fibroblast Growth Factor Receptor (FGFR) and who have not responded to previous chemotherapy or FGFR inhibitor treatments.

The purpose of the study is to evaluate how effective and safe tinengotinib is for these patients. Participants will receive either tinengotinib or another treatment selected by their doctor. The study will monitor the participants over a period to see how the cancer responds to the treatment and to check for any side effects. The study will also look at how long the participants live without the cancer getting worse.

In addition to tinengotinib, the study involves other medications that may be used as part of the doctor’s choice, including folinic acid, irinotecan, fluorouracil, and oxaliplatin. These medications are given through injections or infusions. The study aims to provide more information on the best treatment options for patients with this type of cancer.

1 joining the study

Upon joining the study, the patient will be informed about the trial’s objectives and procedures. The patient must provide informed consent, confirming understanding and agreement to participate.

2 initial assessment

The patient will undergo an initial assessment to confirm eligibility. This includes verifying the diagnosis of cholangiocarcinoma, a type of cancer affecting the bile ducts, and checking for specific genetic markers related to the FGFR2 gene.

The patient’s overall health and organ function will be evaluated to ensure they meet the study’s requirements.

3 treatment phase part A

In Part A of the treatment phase, the patient will receive tinengotinib orally. The dosage will be either 8 mg or 10 mg once daily. The purpose is to assess the safety and tolerability of the medication.

The patient will be monitored for any side effects or adverse reactions during this period.

4 treatment phase part B

In Part B, the patient will continue with the selected dose of tinengotinib based on the results from Part A. The focus will be on evaluating the effectiveness of the treatment in controlling the disease.

The patient’s progress will be compared to other treatment options chosen by the physician.

5 additional treatments

Depending on the treatment plan, the patient may receive additional medications such as folinic acid, irinotecan hydrochloride trihydrate, fluorouracil, and oxaliplatin. These are administered intravenously and are part of the standard chemotherapy regimen.

The frequency and duration of these treatments will be determined by the study protocol and the patient’s response.

6 monitoring and follow-up

Throughout the trial, the patient will undergo regular monitoring to assess the treatment’s impact on the disease and overall health. This includes imaging tests and blood tests.

The patient will also be asked to report any side effects or changes in symptoms.

7 end of treatment

At the end of the treatment period, the patient’s response to the therapy will be evaluated. This includes measuring progression-free survival, which is the time during and after treatment that the patient lives with the disease without it getting worse.

The patient will receive guidance on the next steps, which may include further treatment or follow-up care.

Who Can Join the Study?

Must be 18 years or older at the time of signing the informed consent form.
Must be able to understand and sign the informed consent form and follow the study rules.
Must have a confirmed diagnosis of cholangiocarcinoma or adenocarcinoma of the bile ducts, with evidence that the disease cannot be surgically removed or has spread to other parts of the body.
Must have documentation showing a specific change in the FGFR2 gene.
Must have received at least one previous chemotherapy treatment and exactly one FGFR inhibitor approved by the FDA.
Must have a disease that can be measured by imaging tests like CT or MRI. This means having at least one tumor that is a certain size, and it should not be in an area that was previously treated with radiation unless it is a new tumor or shows signs of growth after radiation.
Must agree to have blood taken for a special test called a liquid biopsy to look at genes.
Must have a performance status of 0 to 1 on the ECOG scale, which measures how well a person can perform daily activities.
Must have adequate organ function, which will be checked through various blood tests. These tests include checking the number of certain blood cells, liver enzymes, bilirubin levels, kidney function, and blood clotting ability.
Must agree to use effective birth control methods to prevent pregnancy during the study and for at least 3 months after the study ends. This applies to both male and female participants unless they are surgically sterile or have not had a menstrual period for 12 months or more.

Who Cannot Join the Study?

Patients who have not been diagnosed with cholangiocarcinoma, which is a type of cancer that forms in the bile ducts.
Patients who do not have changes in their FGFR genes. FGFR stands for Fibroblast Growth Factor Receptor, which is a type of protein that can be involved in cancer growth.
Patients who have not previously been treated with chemotherapy or FGFR inhibitors and have not had their cancer return or resist these treatments.
Patients who are not within the specified age range for the study.
Patients who are not willing or able to follow the study procedures and requirements.
Patients who have other medical conditions that might interfere with the study or make participation unsafe.
Patients who are pregnant or breastfeeding.
Patients who are part of a vulnerable population that requires special protection.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Institut Gustave Roussy	Villejuif	France
Medizinische Hochschule Hannover	Hanover	Germany
Hospital Universitario Hm Sanchinarro	Madrid	Spain
Azienda Ospedaliera Universitaria Universita’ Degli Studi Della Campania Luigi Vanvitelli	Naples	Italy
IRCCS Humanitas Research Hospital	Rozzano	Italy
Universitaetsklinikum Heidelberg AöR	Heidelberg	Germany
Katholieke Universiteit te Leuven	Leuven	Belgium
Hospital Universitario De Navarra	Pamplona	Spain
Unidade Local De Saúde De Santa Maria, E.P.E.	Lisbon	Portugal

Other Sites

Site Name	City	Country
Krankenhaus Nordwest GmbH	Frankfurt	Germany
Asklepios Kliniken Hamburg GmbH	Hamburg	Germany
Hopital Saint Antoine	Paris	France
IRCCS Istituto Nazionale Tumori Fondazione Pascale	Naples	Italy
Centro Ricerche Cliniche Di Verona S.r.l.	Verona	Italy
Universitair Ziekenhuis Gent	Gent	Belgium
Hospital General Universitario Gregorio Maranon	Madrid	Spain
Hopital Beaujon	Clichy	France
Hospital Universitario 12 De Octubre	Madrid	Spain
Clinique De La Sauvegarde	Lyon	France
IHFB Cognacq Jay	Levallois-Perret	France
ASST Grande Ospedale Metropolitano Niguarda	Milan	Italy
Istituto Di Candiolo Fondazione Del Piemonte Per Loncologia IRCCS	Candiolo	Italy
Hospital Clinic De Barcelona	Barcelona	Spain
Champalimaud Clinical Centre	Lisbon	Portugal
Hospital Universitario Fundacion Jimenez Diaz	Madrid	Spain
Universita’ Di Pisa	Pisa	Italy
Universita’ Politecnica Delle Marche	Ancona	Italy
Universidade De Santiago De Compostela	Santiago De Compostela	Spain
Institut Sainte Catherine	Avignon	France
Fondazione I.R.C.C.S. Istituto Neurologico Besta	Milan	Italy
Kfzdmwlileuup Rjujjrnkhu Gfjb	Reutlingen	Germany
Nls Lsl Gdflvkalcx Tlfvxrqrgmaii Gyej	Wiener Neustadt	Austria
Ohyejibbrbzonh Lqdd Gawf	Linz	Austria
Ihobvelx Rhvxsjdhc Pvr Lc Ssryix Dgs Tbrskc Dryf Avgplvp Ioeq Scljsp	Meldola	Italy
Bujmguzp Uqlnccnkuf Httjpbej Caftdi	Besançon	France
Akcdfvi Ofczzbzehul Uorquegondfpt Scmmgu	Siena	Italy
Ntutywlc Isvyelbq Owhlscrea Ipm Msxdg Shiwhbmvkmolzpdfyntatuzbzavd Imwhkrbi Bihjuvvc	Cracow	Poland
Kjqtuknx dco Uyhjwmruynqg Mjygnqwt Anr	Munich	Germany
Urbxsqczva Os Apbfzlw	Edegem	Belgium
Hwlriyml Vcbs dfyrwgym	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
Austria	Recruiting	31.12.2023
Belgium	Recruiting	31.12.2023
France	Recruiting	31.12.2023
Germany	Recruiting	31.12.2023
Italy	Recruiting	31.12.2023
Poland	Recruiting	31.12.2023
Portugal	Recruiting	31.12.2023
Spain	Recruiting	31.12.2023

Trial locations

Investigated drugs:

Tinengotinib is an oral medication being studied for its potential to treat cholangiocarcinoma, a type of cancer that affects the bile ducts. This medication is specifically being tested in patients whose cancer has certain changes in the fibroblast growth factor receptor (FGFR) and who have not responded to previous chemotherapy or FGFR inhibitor treatments. The study aims to determine how safe and effective tinengotinib is for these patients.

Physician’s Choice refers to the standard treatment options that a doctor might choose for a patient with cholangiocarcinoma, based on the patient’s specific condition and medical history. This could include a variety of treatments that are already approved and commonly used for this type of cancer. The study compares the effects of tinengotinib to these standard treatment options to see which is more effective.

Investigated diseases:

Cholangiocarcinoma

Cholangiocarcinoma – Cholangiocarcinoma is a type of cancer that forms in the bile ducts, which are the tubes that carry bile from the liver to the gallbladder and small intestine. It is characterized by the abnormal growth of cells in the bile duct lining, leading to blockages and impaired bile flow. As the disease progresses, it can cause symptoms such as jaundice, abdominal pain, and weight loss. The cancer can spread to nearby tissues and organs, complicating the condition. It is often diagnosed at an advanced stage due to its subtle early symptoms. The progression of cholangiocarcinoma can vary, with some cases advancing more rapidly than others.

Trial ID:

2023-505660-11-00

Protocol code:

TT420C2308

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on the Effectiveness and Safety of Tinengotinib for Patients with Cholangiocarcinoma Resistant to Chemotherapy and FGFR Inhibitors

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?