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Study Comparing Selpercatinib, Cabozantinib, and Vandetanib for Patients with Advanced RET-Mutant Medullary Thyroid Cancer

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What is this study about?

This clinical trial is focused on studying a type of thyroid cancer known as RET-mutant medullary thyroid cancer. This is a specific form of thyroid cancer that is caused by changes in the RET gene. The study is comparing the effectiveness of a new treatment called Selpercatinib with two other existing treatments, Cabozantinib and Vandetanib. These treatments are known as kinase inhibitors, which are medications that can block certain proteins in cancer cells and may help to stop the cancer from growing.

The purpose of the study is to see how well Selpercatinib works compared to the other two treatments in patients who have not previously been treated with kinase inhibitors. Participants in the study will be randomly assigned to receive either Selpercatinib, Cabozantinib, or Vandetanib. The study will monitor the progress of the cancer and how it responds to the treatment over time. The treatments are taken orally, meaning they are swallowed in the form of a pill or capsule.

The study will take place over a period of time, and participants will have regular check-ups to monitor their health and the status of their cancer. The goal is to determine which treatment is most effective in slowing down or stopping the growth of the cancer. This information could help improve treatment options for people with RET-mutant medullary thyroid cancer in the future.

1 joining the study

Upon joining the study, eligibility is confirmed. This includes having medullary thyroid cancer that cannot be surgically removed or has spread, and showing growth in the last 14 months.

Confirmation of a mutation in the RET gene is required. General health must be fair to good, without other serious medical conditions.

Commitment to using highly effective contraception during the study is necessary.

2 randomization

Participants are randomly assigned to receive either selpercatinib or a physician’s choice of cabozantinib or vandetanib.

3 treatment administration

Selpercatinib is administered orally. The dosage and frequency are determined by the study protocol.

Cabozantinib is also administered orally, with dosage and frequency as per the study protocol.

Vandetanib is administered orally, following the study’s specified dosage and frequency.

4 monitoring and assessments

Regular monitoring and assessments are conducted to evaluate the progression of the cancer and the effectiveness of the treatment.

Imaging studies and other tests are performed periodically to track changes in the cancer.

5 end of study participation

The study is estimated to conclude on November 13, 2027. Participation continues until this date or until specific criteria for discontinuation are met.

Who Can Join the Study?

  • Participants must have medullary thyroid cancer that cannot be removed by surgery or has spread to other parts of the body.
  • The cancer must not have been treated with certain medications before.
  • There must be proof from imaging studies that the cancer has grown in the last 14 months.
  • Participants must have evidence that their cancer is caused by a mutation in the RET gene. A mutation is a change in the gene that can cause cancer.
  • Participants must be in fair to good general health and not have another serious medical condition.
  • Participants must be willing to use highly effective contraception during the study. Contraception refers to methods used to prevent pregnancy.
  • Both male and female participants are eligible.

Who Cannot Join the Study?

  • Patients who have already been treated with a type of medication called a kinase inhibitor. A kinase inhibitor is a drug that blocks certain proteins in the body that can help cancer cells grow.
  • Patients who do not have a specific genetic change called a RET mutation in their medullary thyroid cancer. A RET mutation is a change in the DNA that can affect how cancer grows.
  • Patients who are not experiencing progressive cancer. Progressive cancer means that the cancer is getting worse or spreading.
  • Patients who are not considered to have advanced cancer. Advanced cancer is cancer that has spread from where it started to other parts of the body.

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
Oncopole Claudius Regaud Toulouse France
Centr Georges Francois Leclerc Dijon France
Medizinische Hochschule Hannover Hanover Germany
Centre Jean Perrin Clermont Ferrand France
Center For Pediatric And Adolescent Medicine Of The Johannes Gutenberg University Mainz Mainz Germany
Azienda Ospedaliera Universitaria Federico II Di Napoli Naples Italy
Centre Hospitalier Universitaire De Lille Lille France
University Hospital Maastricht Maastricht The Netherlands

Other Sites

Site Name City Country Status
Netherlands Cancer Institute Amsterdam The Netherlands
Centre hospitalier universitaire de Liege Liege Belgium
Hospital Universitario Ramon Y Cajal Madrid Spain
Alexandra Hospital Athens Greece
Universitaetsklinikum Magdeburg AöR Magdeburg Germany
Charite Universitaetsmedizin Berlin KöR Berlin Germany
Universita’ Di Pisa Pisa Italy
Swietokrzyskie Centrum Onkologii Samodzielny Publiczny Zaklad Opieki Zdrowotnej W Kielcach Kielce Poland
Hospital General Universitario Gregorio Maranon Madrid Spain
Fondazione I.R.C.C.S. Istituto Neurologico Besta Milan Italy
Centre Francois Baclesse Caen France
Istituto Auxologico Italiano Milan Italy
Cnpnpo Lxyu Btvxuj Lyon France
Iaznqn Iygxlbad Fhjfyawuokzhs Obnhynxlkkj Rome Italy
Ltcxd Urgispfwgjkq Mlanmxf Clraujh (wwsin Leiden The Netherlands
Ujnlyroloktk Midejiu Comhqbk Gikauxpnb Groningen The Netherlands
Uevcebpnyu Hhqlpkfjz Ppqpn Suunsyypdhw Chelvrf Fnwd Paris France
Allbvwhqbp Ptzftyak Hnddceup dg Mocqybouz &mxcsif Hhdqhlc Ntwf Bouches-du-Rhône France
Cbbbhc Prna Sawukrf STRASBOURG, Alsace France
Izrssbfk Bebwmhof Bordeaux France
Fhqnkegr nibjetagd Muaxo a Hjowaor Prague Czechia
Nilagzjf Impyrdpq Oacwpaqdm Idn Mnkhs Scmqvdkbnmgprxshmlyjathemyxm Ixssmnpp Bctodckx Cracow Poland
Kaiyiohe dij Utjeckycomat Mmcnembb Alk Munich Germany
Uqsgwsxwatamqeaqndxoa Wvesclvfb Apq Wuerzburg Germany
Uzwbpncjmgmucuygdmnsu Eodoz Apo Essen Germany
Ucwgsvrhiz Dupsd Sjcfg Df Rlhv Lx Soiqzfgx Rome Italy
Ckfjyz Hvrubyvaxhd Rneftfct Dvtonhdfnhnfbp Angers France
Fkkctqpui Pqoc Lt Iuerrldihuaqg Bzezztpws Dwg Hrvnytbx Ukaoobgppvvql Lw Pum Madrid Spain
Hbarwdhm Vlfc dfmmcinl Barcelona Spain

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Belgium Belgium
Not recruiting
21.10.2019
Czechia Czechia
Not recruiting
21.10.2019
France France
Not recruiting
21.10.2019
Germany Germany
Not recruiting
21.10.2019
Greece Greece
Not recruiting
21.10.2019
Italy Italy
Not recruiting
21.10.2019
Poland Poland
Not recruiting
21.10.2019
Spain Spain
Not recruiting
21.10.2019
The Netherlands The Netherlands
Not recruiting
21.10.2019

Trial locations

Investigated drugs:

Selpercatinib is a medication being tested in this trial for its effectiveness in treating patients with a specific type of thyroid cancer known as RET-mutant medullary thyroid cancer. It works by targeting and inhibiting certain proteins that are involved in the growth and spread of cancer cells.

Cabozantinib is another medication used in this trial. It is designed to slow down or stop the growth of cancer cells by blocking certain pathways that the cancer cells use to grow and spread.

Vandetanib is also part of this trial. It is used to treat thyroid cancer by interfering with the cancer cells’ ability to grow and divide, helping to control the progression of the disease.

Investigated diseases:

RET-Mutant Medullary Thyroid Cancer – This is a type of thyroid cancer that originates from the parafollicular C cells of the thyroid gland and is associated with mutations in the RET gene. It is a rare form of cancer that can occur sporadically or as part of a genetic syndrome. The disease typically progresses by forming a mass in the thyroid, which may lead to symptoms such as a lump in the neck, difficulty swallowing, or changes in voice. As the cancer advances, it may spread to nearby lymph nodes and other parts of the body. The progression of the disease can vary, with some cases remaining localized while others become more aggressive. Understanding the genetic mutation involved is crucial for determining the course of the disease.

Trial ID:
2023-506782-56-00
Protocol code:
J2G-MC-JZJB
Trial Phase:
Therapeutic confirmatory (Phase III)

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