Clinical trial • Phase III • Oncology|Rare Disease
RIPRETINIB for Advanced gastrointestinal stromal tumour | Gastrointestinal stromal tumour
Phase III trial of RIPRETINIB for Advanced gastrointestinal stromal tumour | Gastrointestinal stromal tumour.
Overview
- Trial Therapeutic Area
- Oncology|Rare Disease
- Trial Disease
- Advanced gastrointestinal stromal tumour | Gastrointestinal stromal tumour
- Trial Stage
- Phase III
- Drug Modality
- Small molecule
- Orphan Drug
- Yes
Key dates
- Initial CTIS Submission Date
- 13-08-2024
- First CTIS Authorization Date
- 04-09-2024
Trial design
Randomised, open-label, test: qinlock (ripretinib) 50 mg tablets (oral; product described as 50 mg tablets, max daily dose 150 mg). comparator: sunitinib aqvida 12,5 mg hartkapseln (sunitinib; oral hard capsules, product described as 12.5 mg capsules, max daily dose 50 mg). schedule/dosing regimen not otherwise specified in the available data.-controlled Phase III trial across 9 sites in France, Italy, Spain and others.
- Randomised
- Yes
- Open Label
- Yes
- Comparator
- Test: QINLOCK (ripretinib) 50 mg tablets (oral; product described as 50 mg tablets, max daily dose 150 mg). Comparator: Sunitinib AqVida 12,5 mg Hartkapseln (sunitinib; oral hard capsules, product described as 12.5 mg capsules, max daily dose 50 mg). Schedule/dosing regimen not otherwise specified in the available data.
- Biomarker Stratified
- True, KIT mutation status (KIT Exon 11 subgroup analyzed; KIT/PDGFRA mutation status required and will be provided/confirmed prior to randomization).
- Target Sample Size
- 240
Eligibility
Recruits 240 The record indicates vulnerable population selection (isVulnerablePopulationSelected=true). Enrollment is restricted to adults (Patients ≥ 18 years) so informed consent is to be provided by the participant. No specific details on assent or additional consent procedures for vulnerable subgroups are provided in the available data..
- Vulnerable Population
- The record indicates vulnerable population selection (isVulnerablePopulationSelected=true). Enrollment is restricted to adults (Patients ≥ 18 years) so informed consent is to be provided by the participant. No specific details on assent or additional consent procedures for vulnerable subgroups are provided in the available data.
Inclusion criteria
- {"criterion_text":"- Patients ≥ 18 years of age at the time of informed consent.\n- Histologic diagnosis of GIST and must be able to provide an archival tumor tissue sample, otherwise, a fresh biopsy is required.\n- Molecular pathology report with mutational status of KIT/PDGFRA must be available. Mutation status must be identified by using a tissue-based PCR/sequencing assay. Molecular pathology report with mutation status of KIT/PDGFRA must be provided to the Sponsor for review prior to randomization. If molecular pathology report is not available or insufficient, an archival tumor tissue sample or fresh biopsy is required for mutation status confirmation by the central laboratory prior to randomization.\n- Patients must have progressed on imatinib or have documented intolerance to imatinib. Imatinib treatment must have been discontinued 10 days prior to the first dose of study drug. All prior imatinib treatment will count as one line of therapy (e.g. adjuvant imatinib and dose escalation of imatinib).\n- Eastern Cooperative Oncology Group (ECOG) PS of ≤ 2 at screening."}
Exclusion criteria
- {"criterion_text":"- imatinib for advanced GIST. Imatinib-containing combination therapy in the first line setting is not allowed.\n- Patients with a prior or concurrent malignancy whose natural history or treatment have the potential to interfere with the safety or efficacy assessment of this clinical trial are not eligible. For example, patients receiving adjuvant cancer treatment are not eligible if those medications are potentially active against GIST or excluded per protocol. NOTE: Patients with a history of breast cancer, requiring continued hormonal treatment (e.g. anti-estrogen or an aromatase inhibitor) may continue treatment. Patients with a history of prostate cancer, requiring continued support with luteinizing hormone releasing hormone (LHRH) agonists, with or without androgens, may continue treatment. NOTE: Patients may not be part of an ongoing or Have prior participation in an investigational drug Study within 30 days of screening.\n- Patient has known active central nervous system metastases.\n- New York Heart Association class II-IV heart disease, myocardial infarction within 6 months of cycle 1 day 1, active ischemia or any other uncontrolled cardiac condition such as angina pectoris, clinically significant cardiac arrhythmia requiring therapy, uncontrolled hypertension or congestive heart failure.\n- Left ventricular ejection fraction (LVEF) < 50% at screening."}
Endpoints
Primary endpoints
- {"endpoint_text":"- PFS of DCC-2618 based on independent radiologic review using mRECIST criteria.","definition_or_measurement_approach":"Progression-free survival assessed by independent radiologic review using mRECIST criteria (independent radiologic review; mRECIST criteria for target/non-target lesions and assessment; PET not acceptable for radiologic assessment)."}
Secondary endpoints
- {"endpoint_text":"- Efficacy • ORR (confirmed CR + confirmed PR) based on independent radiologic review using mRECIST criteria • OS The primary and secondary endpoints will be analyzed for both the KIT Exon 11 (Exon 11 ITT) and the All Patients (AP ITT) population.","definition_or_measurement_approach":"Objective response rate (confirmed complete response + confirmed partial response) by independent radiologic review using mRECIST; Overall Survival (OS); analyses planned for KIT Exon 11 population and all-patients ITT population."}
- {"endpoint_text":"- Safety Safety endpoints that will be evaluated include treatment-emergent adverse events (TEAEs), SAEs, dose reduction or discontinuation of study drug due to toxicity; and changes from baseline in ECOG PS, vital signs, ECGs, LVEF, dermatologic examinations, and clinical laboratory parameters.","definition_or_measurement_approach":"Safety evaluated by recording TEAEs, SAEs, dose modifications/discontinuations due to toxicity, and changes from baseline in ECOG PS, vital signs, ECGs, LVEF, dermatologic exams, and laboratory parameters."}
- {"endpoint_text":"- Pharmacokinetics • Correlation of PK exposure with efficacy/safety • Population-based PK parameters","definition_or_measurement_approach":"Pharmacokinetic sampling to assess exposure and correlation with efficacy and safety; population PK parameter estimation."}
Recruitment
- Planned Sample Size
- 240
- Recruitment Window Months
- 81
- Consent Approach
- Informed consent obtained from each adult participant (participants must be ≥ 18 years). Multiple subject information and informed consent form documents are listed for different countries/languages (examples in file listing: French, Spanish, Italian, Dutch, Norwegian, English), including main ICF and pre-screening ICF documents; no specific assent procedure described.
Geography
- Total Number Of Sites
- 9
- Total Number Of Participants
- 144
France
- Earliest CTIS Part Ii Submission Date
- 28-08-2024
- Latest Decision Or Authorization Date
- 28-04-2025
- Processing Time Days
- 243
- Number Of Sites
- 2
- Number Of Participants
- 49
Sites
- Site Name
- Institut Gustave Roussy
- Department Name
- Oncology
- Contact Person Name
- Axel LE CESNE
- Contact Person Email
- axel.lecesne@gustaveroussy.fr
- Site Name
- Institut Paoli Calmettes
- Department Name
- Oncology
- Contact Person Name
- François BERTUCCI
- Contact Person Email
- berticcuf@ipc.unicancer.fr
Italy
- Earliest CTIS Part Ii Submission Date
- 28-08-2024
- Latest Decision Or Authorization Date
- 26-11-2025
- Processing Time Days
- 455
- Number Of Sites
- 1
- Number Of Participants
- 26
Sites
- Site Name
- Fondazione IRCCS Istituto Nazionale Dei Tumori
- Department Name
- SC Oncologia Medica 2
- Contact Person Name
- Elena Rosa Fumagalli
- Contact Person Email
- elenarosa.fumagalli@istitutotumori.mi.it
Spain
- Earliest CTIS Part Ii Submission Date
- 28-08-2024
- Latest Decision Or Authorization Date
- 26-11-2025
- Processing Time Days
- 455
- Number Of Sites
- 4
- Number Of Participants
- 40
Sites
- Site Name
- Hospital Universitario Hm Sanchinarro
- Department Name
- Oncology Service
- Contact Person Name
- Antonio Cubillo Gracian
- Contact Person Email
- acubillo@hmhospitales.com
- Site Name
- Hospital Universitario La Paz
- Department Name
- Oncology Department
- Contact Person Name
- Virginia Martinez Marin
- Contact Person Email
- virgimarin9@hotmail.com
- Site Name
- Fundacion Instituto Valenciano De Oncologia
- Department Name
- Oncology Service
- Contact Person Name
- Ignacio Romero Noguera
- Contact Person Email
- iromero@fivo.org
- Site Name
- Hospital Universitario De Canarias
- Department Name
- Oncology Service
- Contact Person Name
- Josefina Cruz Jurado
- Contact Person Email
- jcruzjurado@gmail.com
Netherlands
- Earliest CTIS Part Ii Submission Date
- 28-08-2024
- Latest Decision Or Authorization Date
- 01-12-2025
- Processing Time Days
- 460
- Number Of Sites
- 1
- Number Of Participants
- 19
Sites
- Site Name
- Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting
- Department Name
- Research Facility
- Contact Person Name
- Neeltje Steeghs
- Contact Person Email
- n.steeghs@nki.nl
Norway
- Earliest CTIS Part Ii Submission Date
- 28-08-2024
- Latest Decision Or Authorization Date
- 24-11-2025
- Processing Time Days
- 453
- Number Of Sites
- 1
- Number Of Participants
- 10
Sites
- Site Name
- Oslo University Hospital HF
- Department Name
- Department of Oncology
- Contact Person Name
- Kjetil Boye
- Contact Person Email
- Kjetil.Boye@rr-research.no
Sponsor
Primary sponsor
- Full Name
- Deciphera Pharmaceuticals Inc.
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- United States
Contract research organisations
- Name
- Greenphire LLC
- Responsibilities
- Investigator payments
- Name
- Eresearchtechnology Inc.
- Responsibilities
- ePRO, ECG analysis/ review
- Name
- Fortrea Inc.
- Responsibilities
- sponsor duties code 8
- Name
- Advanced Clinical LLC
- Responsibilities
- sponsor duties codes 10; 6
- Name
- IQVIA Limited
- Responsibilities
- sponsor duties codes 1; 12
- Name
- Icon Clinical Research Limited
- Responsibilities
- Clinical chemistry, Clinical haematology
- Name
- Suvoda LLC
- Responsibilities
- sponsor duties codes 14; 3
Third parties
- {"country":"United States","full_name":"Greenphire LLC","duties_or_roles":"Investigator payments","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United States","full_name":"Eresearchtechnology Inc.","duties_or_roles":"ePRO, ECG analysis/ review","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Fortrea Inc.","duties_or_roles":"sponsor duties code 8","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Advanced Clinical LLC","duties_or_roles":"sponsor duties codes 10; 6","organisation_type":"Pharmaceutical company"}
- {"country":"United Kingdom","full_name":"IQVIA Limited","duties_or_roles":"sponsor duties codes 1; 12","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Kcas LLC","duties_or_roles":"Bioanalitycal lab","organisation_type":"Pharmaceutical company"}
- {"country":"Ireland","full_name":"Icon Clinical Research Limited","duties_or_roles":"Clinical chemistry, Clinical haematology","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Suvoda LLC","duties_or_roles":"sponsor duties codes 14; 3","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United States","full_name":"Llx Solutions LLC","duties_or_roles":"sponsor duties code 10","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Transperfect Translations International Inc.","duties_or_roles":"Full TMF QC","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Imaging Endpoints II LLC","duties_or_roles":"Medical image analysis/ review - X-ray, MRI, ultrasound, Primary/ surrogate endpoint test","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Foundation Medicine Inc.","duties_or_roles":"Tumor Mutation Confirmation Testing","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Unisphere Travel Ltd. Inc.","duties_or_roles":"Travel arrangements","organisation_type":"Non-Pharmaceutical company"}
Investigational products
- Investigational Product Name
- QINLOCK 50 mg tablets
- Active Substance
- RIPRETINIB
- Modality
- Small molecule
- Routes Of Administration
- ORAL USE
- Route
- oral
- Authorisation Status
- Marketing authorisation number EU/1/21/1569/001
- Orphan Designation
- Yes
- Starting Dose
- 50 mg
- Maximum Dose
- 150 mg
- Investigational Product Name
- Sunitinib AqVida 12,5 mg Hartkapseln
- Active Substance
- SUNITINIB
- Modality
- Small molecule
- Routes Of Administration
- ORAL USE
- Route
- oral
- Authorisation Status
- Marketing authorisation number 98710.00.00
- Starting Dose
- 12.5 mg
- Maximum Dose
- 50 mg
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