Study on Sacituzumab Govitecan for Patients with Advanced Differentiated and Anaplastic Thyroid Cancer

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What is this study about?

This clinical trial is focused on studying two types of advanced thyroid cancer: Differentiated Thyroid Carcinoma (DTC) and Anaplastic Thyroid Carcinoma (ATC). The treatment being tested is a medication called sacituzumab govitecan, also known by its code name IMMU-132. This medication is a type of drug called an antibody-drug conjugate, which is designed to target and attack cancer cells. The purpose of the study is to evaluate how effective and safe sacituzumab govitecan is for patients with these types of thyroid cancer.

Participants in the study will receive sacituzumab govitecan through an intravenous infusion, which means the medication is given directly into a vein. The study is organized into two groups, or cohorts, based on the type of thyroid cancer. The first group includes patients with advanced DTC that does not respond to radioactive iodine treatment, while the second group includes patients with advanced ATC. The study will monitor how well the cancer responds to the treatment and any side effects that may occur.

The main goal is to see if sacituzumab govitecan can help reduce the size of the tumors in these patients. Researchers will also look at other factors, such as how long the treatment works and the overall survival of the patients. The study aims to provide an additional treatment option for people with these challenging types of thyroid cancer.

1 joining the study

Upon joining the study, the patient will receive a written informed consent form approved by an ethics committee. This document outlines the study’s purpose, procedures, and potential risks and benefits.

The patient must agree to the terms, including not participating in another interventional study during this trial.

2 initial assessment

The patient will undergo an initial assessment to confirm eligibility. This includes a review of medical history, current health status, and previous treatments.

Baseline laboratory tests will be conducted to ensure the patient meets the necessary health criteria.

3 treatment administration

The patient will receive the medication sacituzumab govitecan, administered as an intravenous infusion. This medication is designed to target specific cancer cells.

The dosage and frequency of administration will be determined by the study protocol and the patient’s specific health needs.

4 monitoring and follow-up

Throughout the study, the patient’s response to the treatment will be closely monitored. This includes regular medical check-ups and imaging tests to assess the size and progression of tumors.

The patient’s overall health and any side effects experienced will be documented and managed as necessary.

5 completion of treatment

Upon completion of the treatment phase, the patient’s response will be evaluated to determine the effectiveness of the medication.

The patient will continue to be monitored for any long-term effects or changes in health status.

Who Can Join the Study?

Must provide written consent approved by an ethics committee.
Female patients must agree not to breastfeed or donate eggs during the study and for at least 6 months after the last dose of the study drug.
Male patients must agree not to donate sperm during the study and for at least 6 months after the last dose of the study drug.
Male patients with partners who can become pregnant, or who are pregnant or breastfeeding, must agree to abstain from sex or use a condom plus another form of effective birth control during the study and for at least 6 months after the last dose of the study drug.
Must agree not to participate in another study while receiving treatment in this study.
Must be 18 years of age or older.
Must have a confirmed diagnosis of advanced thyroid cancer that cannot be removed by surgery and does not respond to radioactive iodine treatment.
For patients with differentiated thyroid cancer, must have tried at least one previous treatment and no more than three. For patients with anaplastic thyroid cancer, can be in the first treatment stage or have tried one previous treatment.
Must have cancer that can be measured by scans or tests at the start of the study.
Must provide a sample of tumor tissue for research purposes. If an old sample is not available, a new biopsy must be done.
Must have a performance status of 0 or 1, which means being fully active or having some symptoms but still able to carry out light work.
Must have certain blood test results within normal ranges, including:
- Neutrophil count (a type of white blood cell) of at least 1,500 per mm³.
- Platelet count of at least 100,000 per microliter.
- Hemoglobin level of at least 9 grams per deciliter.
- Serum bilirubin (a liver function test) no more than 1.5 times the normal limit, except for patients with Gilbert’s disease.
- Serum albumin (a protein in the blood) greater than 3 grams per deciliter.
- Creatinine clearance (a kidney function test) of at least 60 mL/min.
- Liver enzymes (ALT and AST) no more than 2.5 times the normal limit, or up to 5 times if there are liver metastases.
Female patients must either:
- Be unable to have children due to menopause or surgical procedures.
- If able to have children, agree not to become pregnant during the study and for at least 6 months after the last dose of the study drug, have a negative pregnancy test before starting the study, and use effective birth control if sexually active.

Who Cannot Join the Study?

Patients who have not been diagnosed with advanced thyroid cancer that does not respond to radioactive iodine treatment.
Patients who do not have advanced anaplastic thyroid cancer, which is a very aggressive form of thyroid 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 able to provide informed consent or are part of a vulnerable population that cannot participate in the study.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Hospital Clinico San Carlos	Madrid	Spain

Other Sites

Site Name	City	Country
MD Anderson Cancer Center	Madrid	Spain
Hospital General Universitario Morales Meseguer	Murcia	Spain
Ajuntament De L Hospitalet De Llobregat	L'hospitalet De Llobregat	Spain
Area Sanitaria De Ferrol	Ferrol	Spain
Hbxovrml Uwgjdeecudxjv Mivgisn Dy Vqfkuujhwh	Santander	Spain
Flylhuloc Pluo Lg Igxkvctklhlvg Blaswqbgf Dus Hqrdpbxr Uoiskolwzqykl Ll Pll	Madrid	Spain
Hopihxvi Vdhn dyrbtqeu	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
Spain	Recruiting	24.12.2023

Trial locations

Investigated drugs:

Sacituzumab Govitecan

Sacituzumab Govitecan is an anti-TROP-2 antibody-drug conjugate. It is designed to target and bind to TROP-2, a protein that is often found in high amounts on the surface of certain cancer cells, including those in differentiated and anaplastic thyroid neoplasms. Once bound, the drug delivers a toxic substance directly to the cancer cells, aiming to destroy them while minimizing damage to normal cells. This study is evaluating the effectiveness and safety of sacituzumab govitecan as a treatment option for patients with these types of thyroid cancers.

Investigated diseases:

Anaplastic thyroid cancer

Differentiated Thyroid Carcinoma (DTC) – This is a type of thyroid cancer that arises from follicular cells, which produce and store thyroid hormones. It is characterized by its ability to absorb iodine, which is used in some treatments. Over time, DTC can become resistant to radioactive iodine, leading to a more advanced stage. The disease typically progresses slowly, but in advanced cases, it can spread to other parts of the body. Patients may experience symptoms such as a lump in the neck, changes in voice, or difficulty swallowing as the disease progresses.

Anaplastic Thyroid Carcinoma (ATC) – This is a rare and aggressive form of thyroid cancer that develops from the follicular cells of the thyroid gland. Unlike other thyroid cancers, ATC does not absorb iodine, making it more challenging to treat. It progresses rapidly and can invade nearby tissues and spread to distant parts of the body. Symptoms often include a rapidly growing neck mass, difficulty breathing or swallowing, and changes in voice. Due to its aggressive nature, ATC requires prompt medical attention to manage its progression.

Trial ID:

2023-504898-20-00

Protocol code:

GETNE-T2318

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on Sacituzumab Govitecan for Patients with Advanced Differentiated and Anaplastic Thyroid Cancer

What is this study about?

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