GIST - Gastrointestinal Stromal TumorINTERESTNCT06619275
Ripretinib (QINLOCK®) According to Current SmPC
An observational study of GIST - Gastrointestinal Stromal Tumor, run by iOMEDICO AG at 1 site in Germany.
Trial summary
The goal of this prospective, observational study INTEREST is to collect real-world data on ripretinib treatment in a broad patient population in Germany. Ripretinib will be administered according to the current SmPC. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- GIST - Gastrointestinal Stromal Tumor
- What is being tested?
- Ripretinib
- How many people
- 10 participants
- Where
- 1 siteGermany
- Study dates
- 17 Oct 2024to 15 Sep 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients diagnosed with advanced GIST who received 3 or more tyrosine kinase inhibitors (including imatinib).
Who may be able to join
- Patient is eligible if all criteria are met:
- Aged 18 years or older.
- Histologically confirmed advanced GIST.
- Patients must have received prior treatment with three or more kinase inhibitors, including imatinib.
- Decision for treatment with ripretinib as per current SmPC.
- Signed written informed consent
Show all 9Show fewer
- Patients are allowed to be enrolled up to 6 weeks after their first dose of ripretinib. Patients with signed written informed consent after start of ripretinib treatment are not participating in the PRO assessments.
- Willingness and capability to participate in Patient-Reported Outcome (PRO) assessment in German language.
- Other criteria according to current SmPC.
Who cannot join
- Participation in an interventional clinical trial within 30 days prior to enrolment or simultaneous participation in an interventional clinical trial except for the follow-up period.
- Patients unable to consent.
- Other contraindications according to current SmPC.
Trial locations and contacts
1 site in 1 country.
Germany1 site
Praxis für interdisziplinäre Onkologie und Hämatologie
Freiburg im Breisgau
About this study
Official title: Ripretinib in Patients With Previously Treated Advanced Gastrointestinal Stromal Tumor (GIST): a Prospective, Longitudinal, Multicenter, Observational Study in Germany
The goal of this prospective, observational study INTEREST is to collect real-world data on ripretinib treatment in a broad patient population in Germany. Ripretinib will be administered according to the current SmPC. Thus, INTEREST will evaluate for the first time ripretinib in GIST patients in a real-world setting in Germany.
The main questions the study aims to answer are:
- Evaluate quality of live (QoL) using the questionnaire EQ-5D-5L to gain knowledge about how ripretinib treatment affects GIST patients' well-being (change compared to Baseline, Time to Deterioration)
- Assessment of effectiveness in routine treatment (Progression-Free Survival, Overall Survival, Best Response, Overall Response Rate, Disease Control Rate
- Assessment of drug safety
- Assessment of parameters of physicians\' treatment decision making
- Description of treatment reality in detail
- Conditions
- GIST - Gastrointestinal Stromal Tumor
- Being tested
- Ripretinib
- Keywords
- advanced
- Medical subject headings
- Gastrointestinal Stromal Tumors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RipretinibDrug
Switch-Control Tyrosine Kinase Inhibitor
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate Quality of Live (QoL): EQ-5D-5L index value
Evaluation of Quality of Life by validated European Quality of Life 5 Dimensions 5 Level Version (EQ-5D-5L) questionnaire. Change from baseline in the EQ-5D-5L index value
Measured: max. 36 months; from the patient-specific study start to end of study (during ripretinib treatment and follow-up)
Evaluate Quality of Live (QoL): EQ-Visual Analogue Scale (VAS)
Evaluation of Quality of Life by validated European Quality of Life 5 Dimensions 5 Level Version (EQ-5D-5L) questionnaire. Change from baseline in the EQ-Visual Analogue Scale (VAS)
Measured: max. 36 months; from the patient-specific study start to end of study (during ripretinib treatment and follow-up)
Secondary outcomes (24)
Subjective well-being: EQ-5D-5L questionnaire (index value)
Time to deterioration (TTD) in the EQ-5D-5L index value
Measured: max. 36 months; from the patient-specific study start to end of study (during ripretinib treatment and follow-up)
Subjective well-being: EQ-5D-5L questionnaire (EQ-VAS)
Time to deterioration (TTD) in the European Quality- Visual Analogue Scale (EQ-VAS)
Measured: max. 36 months; from the patient-specific study start to end of study (during ripretinib treatment and follow-up)
Assess effectiveness in routine treatment: Progression-free survival (PFS)
PFS is defined as time interval measured form the day of first ripretinib administration to first progression or death, whichever comes first. Patients without tumor progression or death at the time of analysis will be censored at their date of last contact.
Measured: max. 36 months; from the patient-specific study start to end of study (during ripretinib treatment and follow-up)
Assess effectiveness in routine treatment: Overall Survival (OS)
OS is defined as the time interval measured form the day of first ripretinib administration to time of death from any cause. Time to last contact will be used if a patient has no documented date of death and OS for the patient will be considered censored.
Measured: max. 36 months; from the patient-specific study start to end of study (during ripretinib treatment and follow-up)
Assess effectiveness in routine treatment: Best response
Best response is defined as Complete Response (CR), Partial Response (PR), Stable Disease (SD), or Progressive Disease (PD))
Measured: max. 36 months; from the patient-specific study start to end of study (during ripretinib treatment and follow-up)
Assess effectiveness in routine treatment: Overall Response Rate (ORR)
ORR is defined as the proportion of patients achieving a complete or partial response as best response.
Measured: max. 36 months; from the patient-specific study start to end of study (during ripretinib treatment and follow-up)
Assess effectiveness in routine treatment: Disease Control Rate (DCR)
DCR is defined as proportion of patients with Complete Response, Partial Response or Stable Disease as best response.
Measured: max. 36 months; from the patient-specific study start to end of study (during ripretinib treatment and follow-up)
Assess drug safety: Incidence of (serious) treatment emergent adverse events (TEAEs)
An adverse event will be classified as TEAE if it is related to the study medication (ripretinib).
Measured: Baseline up to 30 days after ripretinib therapy
Assess drug safety: Incidence of (serious) treatment emergent adverse drug reactions (TEADRs)
An adverse drug reaction will be classified as TEADR if it is temporally related to the study medication (ripretinib).
Measured: Baseline up to 30 days after ripretinib therapy
Assess parameters of physicians' treatment decision making using a questionnaire
Frequency of distinct parameters affecting therapy choice; questionnaire completed by treating physician.
Measured: Baseline
Line of ripretinib treatment
Description of treatment reality in detail: Line of ripretinib treatment
Measured: max. 36 months; from the patient-specific study start to end of study (during ripretinib treatment and follow-up)
Absolute dose intensity
Description of treatment reality in detail: Absolute dose intensity of ripretinib
Measured: max. 36 months; from the patient-specific study start to end of study (during ripretinib treatment and follow-up)
Relative dose intensity
Description of treatment reality in detail: Relative dose intensity of ripretinib
Measured: max. 36 months; from the patient-specific study start to end of study (during ripretinib treatment and follow-up)
Frequency of dose modifications
Description of treatment reality in detail: Frequency of dose modifications during ripretinib treatment
Measured: max. 36 months; from the patient-specific study start to end of study (during ripretinib treatment and follow-up)
Type of dose modifications
Description of treatment reality in detail: Type of dose modifications during ripretinib treatment
Measured: max. 36 months; from the patient-specific study start to end of study (during ripretinib treatment and follow-up)
Reasons of dose modifications
Description of treatment reality in detail: Reasons of dose modifications during ripretinib treatment
Measured: max. 36 months; from the patient-specific study start to end of study (during ripretinib treatment and follow-up)
Duration of treatment
Description of treatment reality in detail: Duration of treatment with ripretinib
Measured: max. 36 months; from the patient-specific study start to end of study (during ripretinib treatment and follow-up)
Reasons for end of treatment (EOT)
Description of treatment reality in detail: Reasons for EOT of treatment with ripretinib
Measured: max. 36 months; from the patient-specific study start to end of study (during ripretinib treatment and follow-up)
Previous local anticancer therapies per treatment setting
Description of treatment reality in detail: Frequency of previous local anticancer therapies per treatment setting
Measured: Baseline
Previous local anticancer therapies per treatment line
Description of treatment reality in detail: Frequency of previous local anticancer therapies per treatment line
Measured: Baseline
Previous systemic anticancer therapies per treatment setting
Description of treatment reality in detail: Frequency of previous systemic anticancer therapies per treatment setting
Measured: Baseline
Previous systemic anticancer therapies per treatment line
Description of treatment reality in detail: Frequency of previous systemic anticancer therapies per treatment line
Measured: Baseline
Concomitant local anticancer therapies
Description of treatment reality in detail: Frequency of concomitant local anticancer therapies (i.e., surgeries and radiotherapies)
Measured: Baseline up to 30 days after ripretinib therapy
Subsequent local anticancer therapies
Description of treatment reality in detail: Frequency of subsequent local anticancer therapies
Measured: From date of end of ripretinib treatment up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2024
- Study start17 Oct 2024
- Primary completion15 Aug 2025
- Study completion15 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GIST - Gastrointestinal Stromal TumorStudies of the same condition, open and under way.
- More trials run by iOMEDICO AGThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- iOMEDICO AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Deciphera Pharmaceuticals (Switzerland) AG
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06619275
- Sponsor's protocol ID
- iOM-120455
- Acronym
- INTEREST
- Status last verified
- Dec 2025
- First submitted
- 26 Sep 2024
- Last updated
- 5 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ripretinib in Patients With Previously Treated Advanced Gastrointestinal Stromal Tumor (GIST): a Prospective, Longitudinal, Multicenter, Observational Study in Germany
- ClinicalTrials.gov ID
- NCT06619275
- Acronym / sponsor ID
- INTEREST / iOM-120455
- Conditions
- GIST - Gastrointestinal Stromal Tumor
- Keywords
- advanced
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- iOMEDICO AGIndustry (pharma, biotech, devices)
- Collaborators
- Deciphera Pharmaceuticals (Switzerland) AG
- Study start
- 17 Oct 2024 (actual)
- Primary completion
- 15 Aug 2025 (actual)
- Study completion
- 15 Sep 2025 (actual)
- First posted
- 1 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this prospective, observational study INTEREST is to collect real-world data on ripretinib treatment in a broad patient population in Germany. Ripretinib will be administered according to the current SmPC. Thus, INTEREST will evaluate for the first time ripretinib in GIST patients in a real-world setting in Germany.
The main questions the study aims to answer are:
- Evaluate quality of live (QoL) using the questionnaire EQ-5D-5L to gain knowledge about how ripretinib treatment affects GIST patients' well-being (change compared to Baseline, Time to Deterioration)
- Assessment of effectiveness in routine treatment (Progression-Free Survival, Overall Survival, Best Response, Overall Response Rate, Disease Control Rate
- Assessment of drug safety
- Assessment of parameters of physicians\' treatment decision making
- Description of treatment reality in detail
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients diagnosed with advanced GIST who received 3 or more tyrosine kinase inhibitors (including imatinib).
Key inclusion criteria (9 listed)
- Aged 18 years or older.
- Histologically confirmed advanced GIST.
- Patients must have received prior treatment with three or more kinase inhibitors, including imatinib.
- Decision for treatment with ripretinib as per current SmPC.
- Signed written informed consent
Key exclusion criteria (3 listed)
- Participation in an interventional clinical trial within 30 days prior to enrolment or simultaneous participation in an interventional clinical trial except for the follow-up period.
- Patients unable to consent.
- Other contraindications according to current SmPC.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RipretinibSwitch-Control Tyrosine Kinase Inhibitor | Drug | – |
Primary outcome
Evaluate Quality of Live (QoL): EQ-5D-5L index value
Time frame: max. 36 months; from the patient-specific study start to end of study (during ripretinib treatment and follow-up)
Evaluation of Quality of Life by validated European Quality of Life 5 Dimensions 5 Level Version (EQ-5D-5L) questionnaire. Change from baseline in the EQ-5D-5L index value
Evaluate Quality of Live (QoL): EQ-Visual Analogue Scale (VAS)
Time frame: max. 36 months; from the patient-specific study start to end of study (during ripretinib treatment and follow-up)
Evaluation of Quality of Life by validated European Quality of Life 5 Dimensions 5 Level Version (EQ-5D-5L) questionnaire. Change from baseline in the EQ-Visual Analogue Scale (VAS)
24 secondary outcomes
Subjective well-being: EQ-5D-5L questionnaire (index value)
Time frame: max. 36 months; from the patient-specific study start to end of study (during ripretinib treatment and follow-up)
Subjective well-being: EQ-5D-5L questionnaire (EQ-VAS)
Time frame: max. 36 months; from the patient-specific study start to end of study (during ripretinib treatment and follow-up)
Assess effectiveness in routine treatment: Progression-free survival (PFS)
Time frame: max. 36 months; from the patient-specific study start to end of study (during ripretinib treatment and follow-up)
Assess effectiveness in routine treatment: Overall Survival (OS)
Time frame: max. 36 months; from the patient-specific study start to end of study (during ripretinib treatment and follow-up)
Assess effectiveness in routine treatment: Best response
Time frame: max. 36 months; from the patient-specific study start to end of study (during ripretinib treatment and follow-up)
Assess effectiveness in routine treatment: Overall Response Rate (ORR)
Time frame: max. 36 months; from the patient-specific study start to end of study (during ripretinib treatment and follow-up)
Assess effectiveness in routine treatment: Disease Control Rate (DCR)
Time frame: max. 36 months; from the patient-specific study start to end of study (during ripretinib treatment and follow-up)
Assess drug safety: Incidence of (serious) treatment emergent adverse events (TEAEs)
Time frame: Baseline up to 30 days after ripretinib therapy
Assess drug safety: Incidence of (serious) treatment emergent adverse drug reactions (TEADRs)
Time frame: Baseline up to 30 days after ripretinib therapy
Assess parameters of physicians' treatment decision making using a questionnaire
Time frame: Baseline
Line of ripretinib treatment
Time frame: max. 36 months; from the patient-specific study start to end of study (during ripretinib treatment and follow-up)
Absolute dose intensity
Time frame: max. 36 months; from the patient-specific study start to end of study (during ripretinib treatment and follow-up)
Relative dose intensity
Time frame: max. 36 months; from the patient-specific study start to end of study (during ripretinib treatment and follow-up)
Frequency of dose modifications
Time frame: max. 36 months; from the patient-specific study start to end of study (during ripretinib treatment and follow-up)
Type of dose modifications
Time frame: max. 36 months; from the patient-specific study start to end of study (during ripretinib treatment and follow-up)
Reasons of dose modifications
Time frame: max. 36 months; from the patient-specific study start to end of study (during ripretinib treatment and follow-up)
Duration of treatment
Time frame: max. 36 months; from the patient-specific study start to end of study (during ripretinib treatment and follow-up)
Reasons for end of treatment (EOT)
Time frame: max. 36 months; from the patient-specific study start to end of study (during ripretinib treatment and follow-up)
Previous local anticancer therapies per treatment setting
Time frame: Baseline
Previous local anticancer therapies per treatment line
Time frame: Baseline
Previous systemic anticancer therapies per treatment setting
Time frame: Baseline
Previous systemic anticancer therapies per treatment line
Time frame: Baseline
Concomitant local anticancer therapies
Time frame: Baseline up to 30 days after ripretinib therapy
Subsequent local anticancer therapies
Time frame: From date of end of ripretinib treatment up to 36 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2025.
- Individual participant dataSharing planned: No
Related trials for GIST - Gastrointestinal Stromal Tumor
RecruitingPhase 2
A Study to Learn More About How Well Treatment With Sevabertinib (BAY 2927088) Tablets Works and How Safe it is in Participants Who Have a Solid Tumor With Mutations of the Human Epidermal Growth Factor Receptor 2 (HER2)
Advanced Solid Tumors, HER2 Mutation
RecruitingPhase 2
Belzutifan/MK-6482 for the Treatment of Advanced Pheochromocytoma/Paraganglioma (PPGL), Pancreatic Neuroendocrine Tumor (pNET), Von Hippel-Lindau (VHL) Disease-Associated Tumors, Advanced Gastrointestinal Stromal Tumor (wt GIST), or Solid Tumors With HIF-2α Related Genetic Alterations (MK-6482-015)
Pheochromocytoma/Paraganglioma, Pancreatic Neuroendocrine Tumor
RecruitingObservational study
Surgery in Gastrointestinal Stromal Tumors (GISTs) for Treatment, Tumor Modeling, and Genomic Analysis
Gastric Cancer, Gastric Neoplasm
RecruitingPhase 1
A Study of Ziftomenib in Combination With Imatinib in Patients With Advanced Gastrointestinal Stromal Tumors (GIST)
Gastrointestinal Stromal Tumor (GIST), Gastrointestinal Stromal Cancer
RecruitingPhase 2
ctDNA-Guided Sunitinib And Regorafenib Therapy for GIST
Gastrointestinal Stromal Tumors
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of GIST - Gastrointestinal Stromal Tumor, run by iOMEDICO AG at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate Quality of Live (QoL): EQ-5D-5L index value (time frame: max. 36 months; from the patient-specific study start to end of study (during ripretinib treatment and follow-up)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2025.