Study on Selpercatinib for Adults with Advanced or Metastatic Solid Tumors with RET Activation

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What is this study about?

This clinical trial is focused on treating patients with certain types of advanced cancers, specifically those that have a change in a gene called Rearranged During Transfection (RET). The cancers being studied include Non-Small Cell Lung Cancer, Medullary Thyroid Cancer, Colon Cancer, Breast Cancer, Pancreatic Cancer, Papillary Thyroid Cancer, and other solid tumors with this specific gene change. The treatment being tested is a medication called selpercatinib, which is taken as a capsule by mouth.

The purpose of this study is to provide access to selpercatinib for patients who have these advanced cancers with the RET gene change. The study is designed to help patients who are not eligible for other ongoing clinical trials of selpercatinib. Participants will take the medication over a period of time, and their health will be monitored by their healthcare team. The study does not involve any specific data analysis or endpoints, meaning it is primarily focused on providing the treatment rather than collecting data for research purposes.

Patients who participate in this study will receive selpercatinib as part of an expanded access program, which is a way to provide treatment to patients who have no other options available. The treatment period can last up to 84 days, and the medication is taken orally. This study aims to support patients with advanced cancers by offering them a potential treatment option when other therapies are not suitable or available.

1 joining the study

Upon joining the study, the patient must provide a signed informed consent. This consent is necessary before any specific procedures related to the study can begin.

The patient must be 18 years of age or older and have a diagnosis of a locally advanced or metastatic tumor with a specific genetic change known as RET alteration.

2 eligibility confirmation

The patient must not be eligible for any ongoing clinical trials involving selpercatinib due to various reasons such as clinical, geographic, or financial constraints.

The patient must have progressed on, be intolerant to, or have no standard therapy available. Adequate blood, kidney, and liver function are required.

3 treatment with selpercatinib

The patient will receive selpercatinib, which is administered orally. The specific dosage and frequency will be determined by the treating physician.

The treatment will continue for the duration of the study, which is estimated to end on November 3, 2024.

4 birth control requirements

Patients of childbearing potential must use double effective birth control methods during the treatment and for three months after the last dose. This involves one method used by the patient and another by their partner.

Who Can Join the Study?

The patient must have a tumor that is either locally advanced or has spread to other parts of the body. The tumor must show evidence of a change in the RET gene that makes it active.
The patient is not eligible for another ongoing clinical trial with the drug selpercatinib due to reasons like location, cost, or the trial being closed, but is considered a good candidate for this treatment by their doctor and the study sponsor.
The patient has tried standard treatments, but they did not work, or the patient cannot tolerate them, or there are no standard treatments available.
The patient must be 18 years old or older.
The patient must have good blood, kidney, and liver function as defined in the study guidelines.
The patient or their legally authorized representative must be able to give consent to participate in the study.
The patient must provide a signed informed consent before any study-specific procedures are done.
Men and women who can have children must agree to use two effective methods of birth control, one used by the patient and another by their partner, during the treatment and for 3 months after the last dose.

Who Cannot Join the Study?

Patients who are younger than 18 years old cannot participate.
Patients without a diagnosis of a solid tumor with an activating RET alteration cannot participate. An activating RET alteration is a specific change in the RET gene that can cause cancer cells to grow.
Patients who are not able to understand or agree to the study requirements cannot participate.
Patients who have other medical conditions that might interfere with the study cannot participate.
Patients who are pregnant or breastfeeding cannot participate.
Patients who are currently participating in another clinical trial cannot participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Institut Gustave Roussy	Villejuif	France
Hospital Universitario Hm Sanchinarro	Madrid	Spain

Other Sites

Site Name	City	Country
Universita’ Di Pisa	Pisa	Italy
Fondazione I.R.C.C.S. Istituto Neurologico Besta	Milan	Italy
Aiwrnwmfcj Pnesqnup Hjxkxvfi Ds Mdkwpccqt	Marseille	France
Nwyzbmyv Iifzckjq Ofmacviel Iiw Mmgbl Swdrqezuwkatoqpxsuhfvqxblndn Isjldzim Biclrnsy	Cracow	Poland
Uzznredafmpyui Cwchqsd Kdilxgmfv	Gdansk	Poland
Hwwelonf Vall dqmhavwc	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
France	Not recruiting	15.03.2019
Italy	Not recruiting	15.03.2019
Poland	Not recruiting	15.03.2019
Spain	Not recruiting	15.03.2019

Trial locations

Investigated drugs:

Selpercatinib

Selpercatinib is a medication used in this clinical trial to treat patients with locally advanced or metastatic solid tumors that have specific genetic changes known as RET alterations. This medication is designed to target and inhibit the activity of the RET protein, which can help slow down or stop the growth of cancer cells. The trial aims to provide access to this treatment for patients who meet the criteria.

Investigated diseases:

Non-Small Cell Lung Cancer – This is the most common type of lung cancer, accounting for about 85% of cases. It typically grows and spreads more slowly than small cell lung cancer. The disease often begins in the cells lining the air passages and can spread to other parts of the body if not managed. Symptoms may include a persistent cough, chest pain, and difficulty breathing.

Medullary Thyroid Cancer – A rare form of thyroid cancer that originates from the parafollicular C cells of the thyroid gland. It can occur sporadically or as part of a genetic syndrome. The disease may present with a neck mass, difficulty swallowing, or changes in voice. It can spread to lymph nodes and other organs.

Colon Cancer – This cancer starts in the colon or rectum, parts of the large intestine. It often begins as small, benign clumps of cells called polyps, which can become cancerous over time. Symptoms may include changes in bowel habits, blood in the stool, and abdominal discomfort.

Breast Cancer – A common cancer that forms in the cells of the breasts, often in the ducts or lobules. It can spread to other parts of the body if not detected early. Symptoms may include a lump in the breast, changes in breast shape, or skin dimpling.

Pancreatic Cancer – This cancer begins in the tissues of the pancreas, an organ that lies behind the lower part of the stomach. It often goes undetected until it is advanced due to its location. Symptoms may include jaundice, weight loss, and abdominal pain.

Papillary Thyroid Cancer – The most common type of thyroid cancer, arising from follicular cells. It generally grows slowly and is often found in one lobe of the thyroid gland. Symptoms may include a lump in the neck, trouble swallowing, or hoarseness.

Other Solid Tumors With Evidence of Activating RET Alteration – These are various types of solid tumors that have genetic changes in the RET gene, which can drive cancer growth. These tumors can occur in different organs and may present with symptoms specific to the affected area. The presence of RET alterations can influence the behavior and progression of these tumors.

Trial ID:

2023-507678-42-00

Protocol code:

LOXO-RET-18037

NCT ID:

NCT03906331

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Selpercatinib for Adults with Advanced or Metastatic Solid Tumors with RET Activation

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