Recruiting

Study of Pemigatinib for Patients with Recurrent or Metastatic Solid Tumors with FGFR Gene Alteration

Verified siteRegistered drugNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of a medication called pemigatinib on certain types of cancer. Specifically, it targets patients with solid tumors that have a change in a gene known as FGFR. These tumors are either recurring or have spread to other parts of the body, which is known as metastatic cancer. The study is looking at cases where these genetic changes are not already being treated with approved medications in France.

The purpose of the study is to see how well pemigatinib works in slowing down or reducing the growth of these tumors. Participants in the study will take pemigatinib in the form of tablets. Some participants may receive a placebo instead. The study will monitor the effects of the medication over a period of time to understand its impact on tumor growth and overall health. The trial will also assess the safety and any side effects of the treatment.

Throughout the study, participants will undergo regular check-ups and imaging tests like MRI or CT scans to track the progress of their cancer. The study aims to provide valuable information on whether pemigatinib can be an effective treatment option for patients with these specific genetic changes in their tumors. The trial is expected to continue until 2028, with recruitment starting in late 2024.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Beginning of treatment
Upon joining the clinical trial, you will begin treatment with a medication called pemigatinib. This medication is provided in the form of tablets and is taken orally.
The dosage of pemigatinib is 4.5 mg per tablet. You will be instructed on the specific frequency and duration of administration by the medical team overseeing the trial.
Step 2
Regular monitoring
Throughout the trial, your health and response to the treatment will be closely monitored. This includes regular medical check-ups and assessments to evaluate the effectiveness of the treatment on tumor growth.
You may undergo imaging tests such as CT or MRI scans to measure any changes in the size of the tumor. These tests will be conducted at specified intervals to track your progress.
Step 3
Evaluation of response
The primary goal of the trial is to assess the efficacy of pemigatinib in reducing tumor growth. Your response to the treatment will be evaluated based on the changes in tumor size and growth rate.
The medical team will determine if there is an objective response, which means a significant reduction in tumor size or growth rate, as compared to the measurements taken before the treatment started.
Step 4
Safety and side effects
Your safety is a priority during the trial. Any side effects or adverse reactions to the medication will be monitored and documented.
You will be asked to report any symptoms or changes in your health to the medical team, who will provide guidance and support to manage any side effects.
Step 5
Completion of trial
The trial is expected to continue until the estimated end date in May 2028. Your participation may last until the trial is completed or until the medical team determines it is appropriate for you to stop.
Upon completion of the trial, you will have a final assessment to evaluate the overall impact of the treatment on your condition.

Who can join the trial?

22 criteria

Must have a solid tumor confirmed by a test called histology or cytology.
Must have adequate blood function:
- ANC (a type of white blood cell) greater than 1.5 x 10⁹/L
- Platelets (cells that help with blood clotting) greater than 75 x 10⁹/L
- Hemoglobin (a protein in red blood cells) greater than 9.0 g/dL. Blood transfusion is allowed if done at least 2 weeks before starting treatment.
- Must have adequate liver function:
  - ALT and AST (liver enzymes) less than 2.5 times the upper limit of normal (ULN), or less than 5 times ULN if there are liver metastases.
  - Total bilirubin (a substance made by the liver) less than 1.5 times ULN, or less than 2.5 times ULN if there is Gilbert’s syndrome or liver metastases.
  - ALP (another liver enzyme) less than 3 times ULN.
  - Must have adequate kidney function: serum creatinine clearance greater than 30 mL/minute, calculated using a formula called Cockroft-Gault.
  - Serum phosphate levels must be less than or equal to the normal limit, and serum calcium levels must be within the normal range.
  - Potassium levels must be within the normal range. Supplements can be used to correct potassium levels during screening.
  - Men and women who can have children must agree to use effective birth control during the study and for at least one week after the last dose of the study drug. Men must also agree not to donate sperm, and women must agree not to donate eggs during this time.
  - Women who can have children must have a negative pregnancy test within 14 days before starting treatment.
  - Must be part of a social security system.
  - Must sign a written consent form before any study procedures. If unable to sign, a trusted person can sign on their behalf.
  - Must have a type of cancer with a specific genetic change called FGFR1, 2, or 3 fusion/rearrangement or mutation.
  - Must be 18 years or older.
  - Must have an ECOG performance status of 2 or less. This is a scale that measures how well a person can perform daily activities.
  - Must not have any other suitable treatment options and must be considered to benefit from an FGFR inhibitor by their doctor.
  - Must have an estimated life expectancy of more than 3 months.
  - Must have measurable disease according to a standard called RECIST1.1. Tumors in areas that have been treated before can be measured if they have clearly grown.
  - Must have two tumor evaluations before treatment, done at least 4 weeks apart and no more than 3 months apart, using the same method (CT or MRI) and without any cancer treatment during this time.
  - Must have a minimal increase in tumor growth rate of 0.1 mm/day between the pre-treatment and baseline scans, as assessed by the doctor.

Who cannot join the trial?

8 criteria

Patients who have a type of cancer that is already approved for treatment with any selective FGFR inhibitor in France cannot participate.
Patients who do not have a specific genetic change in their cancer called an FGFR alteration (which includes fusion, rearrangement, or activating mutation) cannot participate.
Patients who are not able to understand or comply with the study requirements cannot participate.
Patients who have other serious health conditions that could interfere with the study cannot participate.
Patients who are pregnant or breastfeeding cannot participate.
Patients who have had another cancer treatment within a certain period before the study starts cannot participate.
Patients who have an active infection or other uncontrolled medical condition cannot participate.
Patients who have a known allergy to the study medication cannot participate.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Assistance Publique Hopitaux De Marseille
Verified
Marseille, France
CHU Grenoble Alpes
Verified
La Tronche, France
Institut De Cancerologie De Lorraine
Responsive
Vandoeuvre Les Nancy, France

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Investigated drugs

Pemigatinib is a medication being studied for its ability to slow down or stop the growth of certain types of cancer. It is specifically being tested in patients who have cancers with changes in a gene called FGFR. These changes can make cancer cells grow uncontrollably. Pemigatinib works by blocking the activity of the FGFR gene, which may help to stop the cancer from growing or spreading. This medication is being used alone, without any other cancer treatments, to see how effective it is in treating these specific types of cancer. Patients in the trial have cancers that have come back or spread to other parts of the body, and the goal is to see if pemigatinib can help manage their disease.

Pemigatinib

What is already known about the treatment

Pemigatinib – Pemigatinib is administered orally in the form of tablets. It is currently being studied in clinical trials for its effectiveness in treating recurrent or metastatic solid cancers that have specific genetic changes known as FGFR alterations. These alterations include fusions, rearrangements, or activating mutations in the FGFR1, FGFR2, or FGFR3 genes. Pemigatinib works by blocking the activity of FGFR proteins, which are involved in cell growth and division, thereby slowing down or stopping the growth of cancer cells. It is classified as a selective FGFR inhibitor, a type of targeted cancer therapy.

Investigated diseases

Recurrent or metastatic solid cancer with FGFR alteration – This type of cancer involves solid tumors that have either returned after treatment or spread to other parts of the body. It is characterized by changes in the FGFR genes, which can include fusions, rearrangements, or activating mutations. These genetic alterations can lead to abnormal cell growth and division. The progression of the disease is marked by the growth and spread of tumors, which can affect various organs and tissues. The behavior of the cancer can vary depending on the specific FGFR alteration and the type of solid tumor involved. The disease can lead to changes in tumor size and growth rate over time.