Study Comparing Ripretinib and Sunitinib for Patients with Advanced Gastrointestinal Stromal Tumors 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 Gastrointestinal Stromal Tumors (GIST). The study is comparing the effectiveness and safety of a new treatment called DCC-2618 with an existing medication named Sunitinib. Patients participating in this study have previously been treated with another medication called Imatinib.

The purpose of the study is to evaluate how well DCC-2618 works in patients with advanced GIST who have already received treatment with Imatinib. During the study, participants will be randomly assigned to receive either DCC-2618 or Sunitinib. The study will monitor the progression of the disease and any side effects experienced by the participants. The treatment will be administered orally, meaning it will be taken by mouth in the form of capsules or tablets.

This study aims to provide valuable information about the potential benefits and risks of using DCC-2618 as a treatment option for patients with advanced GIST. The results will help determine if DCC-2618 can be a more effective treatment compared to Sunitinib for patients who have already been treated with Imatinib.

1 initial assessment

Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying age, diagnosis of gastrointestinal stromal tumors (GIST), and previous treatment with imatinib.

A tumor tissue sample is required for mutation status confirmation. If an archival sample is unavailable, a fresh biopsy is necessary.

2 randomization

Eligible participants are randomly assigned to receive either sunitinib or ripretinib (DCC-2618).

Randomization ensures that each participant has an equal chance of receiving either treatment.

3 treatment administration

Participants receiving sunitinib will take Sunitinib AqVida 12.5 mg capsules orally. The dosage and frequency are determined by the study protocol.

Participants receiving ripretinib will take QINLOCK 50 mg tablets orally. The dosage and frequency are determined by the study protocol.

4 monitoring and assessments

Regular monitoring is conducted to assess the effectiveness and safety of the treatment. This includes radiologic reviews to evaluate tumor progression.

Participants undergo various assessments, including vital signs, ECGs, and laboratory tests, to monitor health and detect any adverse effects.

5 end of treatment

The treatment continues until the study’s estimated end date or until the participant experiences unacceptable side effects or disease progression.

Upon completion, a final assessment is conducted to evaluate the overall response to the treatment.

Who Can Join the Study?

Patients must be 18 years or older at the time they agree to participate in the study.
Patients must have a histologic diagnosis of gastrointestinal stromal tumors (GIST). This means that a sample of the tumor has been examined under a microscope to confirm the type of cancer.
Patients need to provide a tumor tissue sample from a previous biopsy. If this is not available, a new biopsy may be required.
A molecular pathology report showing the mutation status of specific genes called KIT/PDGFRA must be available. This report helps to understand the genetic changes in the tumor. If the report is not available, a tissue sample or new biopsy is needed to confirm this information.
Patients must have either progressed on imatinib (a medication previously used) or have a documented intolerance to it. This means the cancer has worsened despite treatment, or the patient cannot tolerate the medication. Imatinib treatment should be stopped at least 10 days before starting the study medication.
Patients must have an ECOG performance status of 2 or less at screening. This is a scale used to assess how well a patient can perform daily activities, with lower numbers indicating better function.

Who Cannot Join the Study?

Patients who have not received first-line therapy with imatinib cannot participate.
Patients who do not have advanced gastrointestinal stromal tumors are excluded.
Patients who are not within the specified age range for the study cannot join.
Patients who are part of a vulnerable population may be excluded.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Institut Gustave Roussy	Villejuif	France
Oslo Universitetssykehus HF	Oslo	Norway
Hospital Universitario Hm Sanchinarro	Madrid	Spain

Other Sites

Site Name	City	Country
Fundacion Instituto Valenciano De Oncologia	Valencia	Spain
Hospital Universitario De Canarias	La Laguna	Spain
Netherlands Cancer Institute	Amsterdam	The Netherlands
Fondazione I.R.C.C.S. Istituto Neurologico Besta	Milan	Italy
Fnwaitxhr Prcu Lb Iksdmgzwpjkhr Bpvztpgks Dhj Hrrrxobs Urdvkcbqhveqa La Pyl	Madrid	Spain
Izesckwz Plhimxmdzrbodwt Cwybiu Cptiho	Marseille	France

Trial status

Country	Status	Recruitment Start
France	Not recruiting	18.06.2019
Italy	Not recruiting	18.06.2019
Norway	Not recruiting	18.06.2019
Spain	Not recruiting	18.06.2019
The Netherlands	Not recruiting	18.06.2019

Trial locations

Investigated drugs:

DCC-2618 is an investigational medication being studied for its effectiveness in treating advanced gastrointestinal stromal tumors (GIST). It is being compared to another treatment to see how well it works in patients who have already received initial treatment with another medication.

Sunitinib is a medication used to treat certain types of cancer, including advanced gastrointestinal stromal tumors. In this study, it is being used as a comparison to evaluate the effectiveness of the investigational medication DCC-2618.

Imatinib is a medication that is commonly used as the first-line treatment for gastrointestinal stromal tumors. Patients in this study have previously been treated with imatinib before participating in the trial.

Investigated diseases:

Gastrointestinal stromal tumour

Gastrointestinal Stromal Tumors – Gastrointestinal stromal tumors (GIST) are a type of tumor that occurs in the digestive tract, most commonly in the stomach or small intestine. They originate from special cells in the wall of the gastrointestinal tract known as interstitial cells of Cajal. These tumors can vary in size and may grow slowly or more rapidly, depending on various factors. As they progress, they can cause symptoms such as abdominal pain, bleeding, or a feeling of fullness. GISTs are often characterized by mutations in specific genes, which can influence their behavior and response to treatment. They are considered a rare type of cancer, and their progression can be monitored through imaging and other assessments.

Trial ID:

2024-513277-52-00

Protocol code:

DCC-2618-03-002

NCT ID:

NCT03673501

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study Comparing Ripretinib and Sunitinib for Patients with Advanced Gastrointestinal Stromal Tumors Previously Treated with Imatinib

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?