#1 Clinical Trials Search in Europe

Gastrointestinal stromal tumour – Trials in Disease

Go back

Ongoing Clinical Trials for Gastrointestinal Stromal Tumour

There are currently 14 ongoing clinical trials investigating new treatments for gastrointestinal stromal tumour (GIST). These trials are testing various medications including targeted therapies, immunotherapies, and combinations of treatments. Studies are taking place across multiple European countries, offering patients access to promising investigational treatments after standard therapies have failed or in earlier stages of disease.

Clinical trial locations

Study of IDRX-42 for Patients with Metastatic or Unresectable Gastrointestinal Stromal Tumors (GIST)

This trial is testing a new medication called IDRX-42 in patients whose tumours have spread or cannot be removed by surgery. IDRX-42 is a targeted therapy that blocks specific proteins called tyrosine kinases that help cancer cells grow.

Who can participate: Adults aged 18 or older with confirmed metastatic or unresectable GIST who have experienced disease progression after treatment with imatinib. Participants must have a mutation in either the KIT or PDGFRA gene (except exon 18) and at least one measurable tumour. They must also be able to perform daily activities with an ECOG performance status of 0 or 1.

Who cannot participate: Patients with other types of cancer beyond GIST, those who have had surgery to remove their tumours completely, pregnant or breastfeeding women, and those with serious health conditions that could interfere with the study.

Treatment approach: The trial is divided into phases. The first phase determines the safest dose of IDRX-42 that patients can tolerate. Participants take the medication orally as tablets or capsules. The second phase assesses how well IDRX-42 works in reducing tumour size or slowing growth. Throughout the study, participants undergo regular monitoring including physical exams, blood tests, and imaging studies to evaluate the treatment’s effects.

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

This trial compares two treatments – ripretinib and sunitinib – for patients with advanced GIST who have specific genetic changes in their tumours. Both medications work by blocking proteins that promote tumour growth.

Who can participate: Men and women aged 18 or older with confirmed metastatic or unresectable GIST who have specific mutations in KIT exons 11 and co-occurring mutations in exons 17 and/or 18. Participants must have experienced disease worsening after imatinib treatment (stopped at least 10 days before joining) and have an ECOG performance status of 0, 1, or 2. Women of childbearing potential must have a negative pregnancy test.

Who cannot participate: Patients without the required KIT exon mutations, those outside the specified age range, and vulnerable populations requiring special care.

Treatment approach: Participants are randomly assigned to receive either ripretinib (50 mg tablets) or sunitinib (12.5 mg capsules) taken orally once daily. The study monitors how long patients live without their disease worsening, assessed through independent radiologic review. Regular follow-up includes physical exams, blood tests, and imaging studies to track treatment response and side effects.

Study on Continuing or Stopping Imatinib in Patients with Advanced or Metastatic Gastrointestinal Stromal Tumors After 10 Years of Treatment

This trial investigates whether continuing or stopping imatinib treatment after at least 10 years is better for patients whose disease has been controlled with the medication.

Who can participate: Adults aged 18 or older with confirmed advanced or metastatic GIST showing c-kit (CD117) expression. Participants must have taken imatinib (300 or 400 mg daily) for at least 10 years with no more than 12 months total or 3 consecutive months of treatment breaks. Their disease must be controlled with no worsening while on imatinib. They must have an ECOG performance status of 0, 1, or 2 and possess medical insurance.

Who cannot participate: Patients who haven’t been treated with imatinib for 10 years, those whose GIST is not controlled, and vulnerable populations.

Treatment approach: Participants are randomly assigned to either continue imatinib or stop the medication. Regular monitoring includes imaging tests like CT or MRI scans every six months for the first five years and annually thereafter. The study evaluates progression-free survival rate at 6 months, overall survival, safety, and quality of life.

Study on Imatinib and Atezolizumab for Patients with Advanced Gastrointestinal Stromal Tumors After Standard Treatments Fail

This study combines imatinib with atezolizumab, an immunotherapy drug, for patients whose tumours have not responded to standard treatments. Atezolizumab helps the immune system recognize and attack cancer cells.

Who can participate: Men and women aged 18 or older with confirmed locally advanced, unresectable, or metastatic GIST who have failed at least three treatments (imatinib, sunitinib, and regorafenib). Participants must have measurable disease, an ECOG performance status of 0 or 1, adequate bone marrow and organ function, and agree to use effective birth control. A tumour sample must be available for research or a biopsy performed before treatment.

Who cannot participate: Patients who haven’t failed standard treatments, those with other types of cancer, severe uncontrolled medical conditions, pregnant or breastfeeding women, organ transplant recipients, those with severe allergic reactions to study drugs, currently participating in other trials, active infections, or history of drug or alcohol abuse.

Treatment approach: Participants are randomly assigned to receive either imatinib alone (taken orally) or imatinib combined with atezolizumab (given through intravenous infusion). Regular monitoring includes physical examinations, blood tests, and imaging studies to assess tumour response. Treatment continues until disease progression or unacceptable side effects occur.

Study on the Effectiveness and Safety of BAY 2927088 for Patients with Advanced Solid Tumors with HER2 Mutations

This trial tests BAY 2927088, a reversible tyrosine kinase inhibitor, in patients with advanced solid tumours (including GIST) that have HER2 mutations. The medication blocks proteins that help cancer cells grow.

Who can participate: Adults aged 18 or older with advanced solid tumours that cannot be surgically removed, including various cancer types but excluding lung cancer. Participants must have tried standard treatments or have no satisfactory alternatives, possess an activating HER2 mutation in their cancer, and have at least one measurable tumour area according to RECIST 1.1 criteria.

Who cannot participate: Patients without HER2 mutations, those outside the age range, pregnant or breastfeeding women, individuals with certain medical conditions that could interfere with the study, recent participants in other clinical trials, and those with allergies to the study medication.

Treatment approach: Participants take BAY 2927088 tablets orally. The study monitors tumour response through regular imaging tests and evaluates side effects every four weeks. Treatment continues until disease progression or unacceptable side effects occur. The trial also assesses quality of life using standardized questionnaires.

Study on the Effectiveness of Imatinib for Patients with Intermediate-Risk Gastrointestinal Stromal Tumor and High Genomic Grade Index

This trial evaluates whether imatinib can prevent cancer recurrence in patients with intermediate-risk GIST who have a high Genomic Grade Index, a measure of how aggressive the cancer might be.

Who can participate: Adults aged 18 or older with intermediate-risk GIST and a Genomic Grade Index higher than 10 as determined by CGH array testing. Participants must have had surgery to remove the primary tumour between 2 weeks and 3 months prior to starting imatinib, with no visible remaining disease (small microscopic traces at removal edges allowed). They must have no distant metastases, an ECOG performance status of 0-2, and no previous radiation, chemotherapy, or targeted therapy in the past 3 years.

Who cannot participate: Patients with different cancer types, those not at intermediate risk, individuals without high Genomic Grade Index, and vulnerable populations.

Treatment approach: Participants are randomly assigned to receive either imatinib or a placebo. Regular monitoring includes thoraco-abdominal and pelvic CT scans to evaluate for metastases. The study assesses metastatic relapse rates at 1, 2, and 3 years, overall survival, treatment tolerance, and quality of life using questionnaires such as the French SF36 and EORTC QLQ-C30.

Study on the Effectiveness of Lenvatinib for Patients with Advanced Gastrointestinal Stromal Tumors After Imatinib and Sunitinib Treatment Failure

This double-blind trial compares lenvatinib to a placebo in patients whose disease has not responded to previous treatments with imatinib and sunitinib. Lenvatinib is a tyrosine kinase inhibitor that blocks proteins promoting cancer cell growth.

Who can participate: Adults aged 18 or older with confirmed locally advanced or metastatic GIST who have previously tried and not responded to both imatinib and sunitinib. Participants must have measurable disease with documented progression, an ECOG performance status of 0, 1, or 2, and normal organ and bone marrow function. They must use effective birth control if sexually active and have medical insurance coverage.

Who cannot participate: Patients who haven’t experienced failure with both imatinib and sunitinib, those without locally advanced or metastatic GIST, individuals outside the specified age range, and vulnerable populations.

Treatment approach: Participants are randomly assigned to receive either lenvatinib capsules (4 mg or 10 mg) or placebo, taken orally once daily. Neither participants nor researchers know which treatment is being given. Regular health assessments monitor tumour progression, overall survival, and quality of life. The study tracks progression-free survival, objective response rate, and side effects throughout the trial.

Study of DCC-3116 and ripretinib combination therapy in patients with advanced gastrointestinal stromal tumor (GIST)

This trial tests a combination of two oral medications – DCC-3116 and ripretinib – in patients with advanced GIST. Both drugs work by blocking proteins that help cancer cells grow.

Who can participate: Adults aged 18 or older with confirmed GIST containing a specific genetic change in KIT exon 11. The disease must have worsened during imatinib treatment or patients could not tolerate imatinib. Participants should not have received any other treatments for GIST besides imatinib. They must have measurable tumours, life expectancy over 3 months, good physical function (ECOG score 0 or 1), normal organ function and blood counts, and willingness to provide a fresh tumour biopsy.

Who cannot participate: Patients under 18, pregnant or breastfeeding women, those who received more than 3 lines of therapy for advanced GIST, individuals with active or untreated brain metastases, significant heart problems, severe liver or kidney disease, active uncontrolled infections, other active cancers requiring treatment, recent major surgery, inability to swallow oral medications, or any condition making participation unsafe.

Treatment approach: Participants receive both QINLOCK (ripretinib) 50 mg tablets and DCC-3116 gastro-resistant tablets by mouth. Regular monitoring includes medical imaging to track tumour response, blood samples to monitor drug levels, and assessments for side effects. Treatment continues as long as patients benefit and tolerate the medications.

Study to Find the Right Dose and Safety of Lutetium (177Lu) Edotreotide and Arginine-Lysine in Children with Somatostatin Receptor-Positive Tumors

This trial determines the appropriate dose of lutetium Lu 177 edotreotide, a targeted radiopharmaceutical therapy, for children with tumours showing somatostatin receptors. An arginine-lysine solution protects the kidneys during treatment.

Who can participate: Children aged 2 to under 18 years with confirmed somatostatin receptor-positive (SSTR-positive) solid tumours or lymphoma that has returned or not responded to at least one previous treatment. Participants must have Karnofsky score of 50% or higher (if over 16) or Lansky score of 50% or higher (if 16 or younger), recovered from previous treatment side effects, adequate heart function if previously treated with certain medications, positive SSTR expression confirmed by testing, and scans showing tumour uptake greater than liver uptake.

Who cannot participate: Patients under 2 years old, those without SSTR-positive tumours, individuals who haven’t tried at least one other treatment, pregnant or breastfeeding individuals, those with medical conditions interfering with study treatment, and those unable to follow study procedures.

Treatment approach: Lutetium Lu 177 edotreotide is administered through intravenous infusion, delivering radiation directly to tumour cells. The arginine-lysine solution is also given intravenously to protect kidney function. Treatment occurs over several cycles with regular check-ups monitoring health and treatment progress. The study evaluates safety, how the body processes the therapy, and effectiveness in reducing tumour size.

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

This trial compares the effectiveness and safety of ripretinib (DCC-2618) with sunitinib in patients with advanced GIST who have already received imatinib treatment.

Who can participate: Adults aged 18 or older with histologically confirmed GIST who have progressed on imatinib or cannot tolerate it. Imatinib treatment must be stopped at least 10 days before starting study medication. Participants must have a tumour tissue sample available (or undergo new biopsy if unavailable), a molecular pathology report showing KIT/PDGFRA mutation status (or tissue for testing), and an ECOG performance status of 2 or less at screening.

Who cannot participate: Patients who haven’t received first-line imatinib therapy, those without advanced GIST, individuals outside the specified age range, and vulnerable populations.

Treatment approach: Participants are randomly assigned to receive either sunitinib AqVida 12.5 mg capsules or QINLOCK (ripretinib) 50 mg tablets, both taken orally. Regular monitoring includes radiologic reviews to evaluate tumour progression, vital signs, ECGs, and laboratory tests to detect adverse effects. Treatment continues until disease progression or unacceptable side effects occur.

Summary

The 14 ongoing clinical trials for gastrointestinal stromal tumours represent diverse treatment approaches across multiple European countries. France leads in trial availability with participation in 11 studies, followed by Spain, Italy, and Germany with 8-9 trials each. The Netherlands, Denmark, and Norway also offer substantial opportunities with 4-6 trials each.

Most trials focus on patients with advanced or metastatic disease who have progressed after standard treatments, particularly imatinib and sunitinib. Several studies are testing novel tyrosine kinase inhibitors such as IDRX-42, ripretinib, lenvatinib, and BAY 2927088. Combination approaches are also being explored, including CGT9486 with sunitinib, DCC-3116 with ripretinib, and immunotherapy combinations like imatinib with atezolizumab or avelumab with axitinib.

Notably, some trials address treatment duration questions for patients already responding to therapy, such as the studies examining whether to continue or stop imatinib after long-term use, or whether to extend treatment from three to five years. One unique trial focuses on pediatric patients with somatostatin receptor-positive tumours using radiopharmaceutical therapy.

The concentration of trials in Western European countries reflects established cancer research infrastructure in these regions. Patients interested in participating should discuss eligibility with their healthcare providers, as most trials require specific genetic mutations, previous treatment history, and adequate organ function.

Ongoing Clinical Trials on Gastrointestinal stromal tumour

  • Study of DCC-3116 and ripretinib combination therapy in patients with advanced gastrointestinal stromal tumor (GIST)

    Recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Denmark France Germany Greece Italy The Netherlands +2

  • Study to Find the Right Dose and Safety of Lutetium (177Lu) Edotreotide and Arginine-Lysine in Children with Somatostatin Receptor-Positive Tumors

    Recruiting

    1 1
    Investigated diseases:
    Investigated drugs:
    France Italy Spain

  • Study on Continuing or Stopping Imatinib in Patients with Advanced or Metastatic Gastrointestinal Stromal Tumors After 10 Years of Treatment

    Recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    France

  • Study on Imatinib and Atezolizumab for Patients with Advanced Gastrointestinal Stromal Tumors After Standard Treatments Fail

    Recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    France

  • Study of IDRX-42 for Patients with Metastatic or Unresectable Gastrointestinal Stromal Tumors (GIST)

    Not recruiting

    1 1
    Investigated diseases:
    Belgium France Germany Italy The Netherlands Spain

  • Study on the Effectiveness of Lenvatinib for Patients with Advanced Gastrointestinal Stromal Tumors After Imatinib and Sunitinib Treatment Failure

    Not recruiting

    1 1
    Investigated diseases:
    Investigated drugs:
    France

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

    Not recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    France Italy The Netherlands Norway Spain

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

    Not recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    France Germany Hungary Italy The Netherlands Norway +2

More information about
Gastrointestinal stromal tumour:

Connected medications: