Study of Ripretinib vs Sunitinib for Patients with Advanced Gastrointestinal Stromal Tumor with Specific KIT Exon Mutations Previously Treated with Imatinib

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What is this study about?

This clinical trial is focused on studying a type of cancer known as Advanced Gastrointestinal Stromal Tumor (GIST). This is a rare cancer that occurs in the digestive tract, most commonly in the stomach or small intestine. The study is comparing two treatments: Ripretinib and Sunitinib. Ripretinib, also known by its code name DCC-2618, is a medication that targets specific proteins involved in cancer growth. Sunitinib is another medication used to treat certain types of cancer by blocking the action of proteins that promote tumor growth.

The purpose of the study is to compare the effectiveness of Ripretinib and Sunitinib in patients with advanced GIST who have specific genetic changes called KIT Exon 11 and Co-occurring KIT Exons 17 and/or 18 Mutations. These mutations are changes in the DNA that can affect how cancer grows and responds to treatment. Patients in this study have previously been treated with another medication called Imatinib but need further treatment due to the progression of their disease.

Participants in the study will be randomly assigned to receive either Ripretinib or Sunitinib. The study will last for a period of up to 24 months, during which time the patients will take the medication orally in the form of tablets or capsules. The progress of the disease will be monitored through regular medical assessments to determine how well the treatment is working. The study aims to provide valuable information on which treatment may be more effective for patients with this specific type of GIST.

1 joining the study

Upon joining the study, you will be randomly assigned to receive either ripretinib or sunitinib. This means you will not choose which medication you receive, but it will be decided by chance.

2 medication administration

If you are assigned to ripretinib, you will take a 50 mg tablet orally once a day. If you are assigned to sunitinib, you will take a 12.5 mg hard capsule orally once a day.

The duration of taking the medication will be determined by the study’s progress and your response to the treatment.

3 regular health assessments

Throughout the study, you will undergo regular health assessments. These assessments will include physical exams, blood tests, and imaging tests to monitor the progression of your condition and your response to the medication.

4 progress evaluation

Your progress will be evaluated based on how long you live without your disease getting worse, known as progression-free survival. This will be assessed by independent radiologic review, which means experts will review your test results to determine the status of your condition.

5 completion of the study

The study is expected to continue until April 16, 2027. Your participation may end earlier if your condition changes or if you decide to withdraw from the study.

Who Can Join the Study?

  • Must be a male or female who is 18 years of age or older.
  • Must have a confirmed diagnosis of Gastrointestinal Stromal Tumor (GIST) with specific genetic changes called KIT exons 11+17/18 mutations. This will be confirmed by a blood test analyzed by a central laboratory.
  • Must have advanced GIST and show signs of the disease getting worse after treatment with a drug called imatinib. Treatment with imatinib must have been stopped at least 10 days before starting the study medication.
  • Must have an ECOG Performance Status of 0, 1, or 2 at screening. This is a scale used to assess how the disease affects daily living abilities, where 0 means fully active and 2 means capable of all self-care but unable to carry out any work activities.
  • Female participants who can have children must have a negative pregnancy test at the start of the study and before the first dose of the study medication.

Who Cannot Join the Study?

  • Patients with any other type of cancer that is not an Advanced Gastrointestinal Stromal Tumor.
  • Patients who have not been diagnosed with KIT exon 11+17/18 mutations. This refers to specific genetic changes in the tumor.
  • Patients who are not within the specified age range for the study.
  • Patients who are part of a vulnerable population, which means they might need special protection or care.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Oslo Universitetssykehus HF Oslo Norway
IRCCS Humanitas Research Hospital Rozzano Italy
Universitaetsklinikum Heidelberg AöR Heidelberg Germany
Universitaet Leipzig Leipzig Germany
Institut Gustave Roussy Villejuif France

Other Sites

Site Name City Country Status
Academisch Ziekenhuis Leiden Leiden The Netherlands
Hospital General Universitario Gregorio Maranon Madrid Spain
Istituto Oncologico Veneto Padua Italy
Universita’ Campus Bio-medico Di Roma Rome Italy
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie-Panstwowy Instytut Badawczy Warsaw Poland
Hospital Universitario Fundacion Jimenez Diaz Madrid Spain
IRCCS Istituto Nazionale Tumori Fondazione Pascale Naples Italy
HELIOS Klinikum Berlin-Buch GmbH Berlin Germany
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo Italy
Fundacion Instituto Valenciano De Oncologia Valencia Spain
Fondazione I.R.C.C.S. Istituto Neurologico Besta Milan Italy
Centre De Lutte Contre Le Cancer Eugene Marquis Rennes France
Hospital Universitario Virgen del Rocío Sevilla Spain
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Awyoolc Uuatc Soavaghwj Lbbwgl Do Bqzdojb Bologna Italy
Hwpqrgif Du Ll Sfspe Cnbd I Snvz Pwk Barcelona Spain
Ccqbkq Ljxz Btugqa Lyon France
Uxvatojtcorywzzvterop Esxap Aiy Essen Germany
Uitrtpvlohgo Mqrjpkg Cyqhghm Gfeirwncb Groningen The Netherlands
Ctsrjuqn Heldetlmzzrt Uzfkfbkvymqgp Dg Vflp Vigo Spain
Hzrlnepg Vfmo dfemjuax Barcelona Spain
Mghtogk Cpoiyf Hwrynsuna Dkgyiyq Fuclgo Budapest Hungary

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

Trial status

Country Status Recruitment Start
France France
Not recruiting
16.10.2023
Germany Germany
Not recruiting
16.10.2023
Hungary Hungary
Not recruiting
16.10.2023
Italy Italy
Not recruiting
16.10.2023
Norway Norway
Not recruiting
16.10.2023
Poland Poland
Not recruiting
16.10.2023
Spain Spain
Not recruiting
16.10.2023
The Netherlands The Netherlands
Not recruiting
16.10.2023

Trial locations

Investigated drugs:

Ripretinib is a medication used in this clinical trial to treat patients with a type of cancer called gastrointestinal stromal tumor (GIST). It works by blocking certain proteins that help cancer cells grow. By doing this, ripretinib can help slow down or stop the growth of the tumor. This medication is being tested to see how well it works compared to another treatment option for patients who have specific genetic mutations in their cancer.

Sunitinib is another medication being tested in this trial for treating advanced gastrointestinal stromal tumors (GIST). It is designed to target and block proteins that are involved in the growth and spread of cancer cells. Sunitinib is already used in treating certain types of cancer, and in this study, it is being compared to ripretinib to see which one is more effective for patients with specific genetic mutations in their tumors.

Investigated diseases:

Advanced Gastrointestinal Stromal Tumor – This is a type of cancer that occurs in the digestive tract, most commonly in the stomach or small intestine. It originates from special cells in the gastrointestinal tract wall known as interstitial cells of Cajal. The disease progresses as the tumor grows and may spread to other parts of the body. Symptoms can include abdominal pain, a feeling of fullness, and gastrointestinal bleeding. As the tumor advances, it can lead to complications such as obstruction of the digestive tract. The progression of the disease is often monitored through imaging studies to assess changes in tumor size and spread.

Trial ID:
2022-503058-37-00
Protocol code:
DCC-2618-03-003
NCT ID:
NCT05734105
Trial Phase:
Therapeutic confirmatory (Phase III)

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