Safety Monitoring of Crizotinib for Patients Continuing from Previous Studies

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What is this study about?

This clinical trial is focused on the continued study of Crizotinib, a medication used to treat certain types of cancer. The study is designed for participants who have been part of previous studies sponsored by Pfizer and have been benefiting from the treatment. The main goal of this study is to monitor the safety of Crizotinib as participants continue their treatment.

Crizotinib is available in capsule form and is taken orally. The study involves two different dosages: 200 mg and 250 mg capsules, known as XALKORI and Crizotinib capsules, respectively. Participants will continue to receive their treatment as they have in previous studies, with the maximum daily dose being 500 mg. The study will last for a period of up to 60 days, during which the safety and any side effects of the medication will be closely monitored.

The study aims to ensure that participants who have been benefiting from Crizotinib can continue their treatment safely. Participants will be monitored for any adverse effects that might lead to the discontinuation of the medication. This study provides an opportunity for ongoing treatment for those who have shown positive results from Crizotinib in earlier trials.

1 joining the study

Upon joining the study, eligibility is confirmed. Participants must be receiving crizotinib and benefiting from it in a previous study.

Participants must meet specific health criteria, including adequate liver, bone marrow, and kidney function.

2 medication administration

Participants will continue taking crizotinib orally. The medication is available in capsule form, with dosages of 200 mg or 250 mg.

The specific dosage and frequency will be determined by the study protocol and the participant’s previous treatment plan.

3 monitoring and safety checks

Regular monitoring is conducted to ensure the safety of participants. This includes checking for any adverse effects that may lead to stopping the medication.

Participants will be observed for any serious adverse events (SAEs) during the study.

4 continuation and follow-up

The study is designed to continue until December 26, 2026, providing ongoing access to crizotinib for those who benefit from it.

Participants will have regular follow-up appointments to assess their health and the effectiveness of the treatment.

Who Can Join the Study?

The participant must be currently receiving a medication called crizotinib and benefiting from it, as determined by the study doctor, in a previous study sponsored by Pfizer.
The participant must agree to follow specific guidelines related to reproduction, which are detailed in a specific section of the study documents.
The participant should not have ongoing severe side effects (Grade 3 or higher) or intolerable moderate side effects (Grade 2) related to crizotinib, except for certain lab-related criteria.
The participant must have adequate organ function, which means:

For adults (18 years and older):

Liver function: Specific blood tests (AST and ALT) should be within 3 times the normal limit, or 5 times if liver issues are due to cancer. Total bilirubin should be within 1.5 times the normal limit, except for those with a condition called Gilbert’s syndrome.
Bone marrow function: A type of white blood cell count (ANC) should be at least 1000/μL, platelets should be at least 50,000/μL, and hemoglobin should be at least 8.0 g/dL.
Kidney function: Should be stable for at least 14 days.

For children (under 18 years):

Liver function: AST and ALT should be within 3 times the normal limit, and bilirubin within 1.5 times the normal limit, or 5 times for AST and ALT if liver issues are due to cancer.
Blood function: ANC should be at least 750/μL and platelets at least 75,000/μL for those without bone marrow issues. For those with bone marrow issues, ANC should be at least 500/μL and platelets at least 50,000/μL.
Kidney function: Should be stable for at least 14 days.

Who Cannot Join the Study?

Participants who are not currently benefiting from the study treatment cannot join.
Participants who were not part of the original Pfizer crizotinib study are not eligible.
Participants who have experienced serious side effects from crizotinib in the past cannot participate.
Participants who have other medical conditions that could interfere with the study treatment are excluded.
Participants who are unable to follow the study procedures or attend required visits cannot join.
Participants who are pregnant or breastfeeding are not eligible.
Participants who are taking other medications that might interact with crizotinib are excluded.

Where you can join this trial?

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Verified Sites

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Other Sites

Site Name	City	Country	Status
Fondazione IRCCS San Gerardo Dei Tintori	Monza	Italy

Trial status

Country	Status	Recruitment Start
Italy	Recruiting	01.09.2022

Trial locations

Investigated drugs:

Crizotinib

Crizotinib is a medication used in this clinical trial to monitor its safety. It is typically used to treat certain types of cancer by blocking the action of an abnormal protein that signals cancer cells to multiply. This helps to slow or stop the spread of cancer cells. Participants in this study are continuing from previous studies involving this medication to ensure its ongoing safety and effectiveness.

Non-Small Cell Lung Cancer – Non-Small Cell Lung Cancer (NSCLC) is a type of lung cancer that includes several subtypes such as adenocarcinoma, squamous cell carcinoma, and large cell carcinoma. It is characterized by the uncontrolled growth of cells in the tissues of the lung. NSCLC tends to grow and spread more slowly than small cell lung cancer. Symptoms may include a persistent cough, chest pain, and shortness of breath. As the disease progresses, it can spread to other parts of the body, including the bones and brain. Early detection is crucial for managing the disease effectively.

Trial ID:

2024-511128-15-00

Protocol code:

A8081075

Trial Phase:

Therapeutic confirmatory (Phase III)

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Safety Monitoring of Crizotinib for Patients Continuing from Previous Studies

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?