Clinical trial • Phase I/II • Oncology
DCC-3116 for Advanced gastrointestinal stromal tumor (GIST)
Phase I/II trial of DCC-3116 for Advanced gastrointestinal stromal tumor (GIST). 87 participants.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Advanced gastrointestinal stromal tumor (GIST)
- Trial Stage
- Phase I/II
- Drug Modality
- Small molecule
- Orphan Drug
- Yes
Key dates
- Initial CTIS Submission Date
- 05-12-2024
- First CTIS Authorization Date
- 14-04-2025
Trial design
Phase I/II trial in Germany, Portugal, Netherlands and others.
- Single Multiple Or Escalation Dose Combined
- Yes
- Target Sample Size
- 87
Eligibility
Recruits 87 adults.
Inclusion criteria
- {"criterion_text":"- Male or female ≥18 years of age\n- Pathologically confirmed GIST with documented mutation in KIT exon 11.\n- Must have progressed on imatinib given in the locally advanced or metastatic setting or have been intolerant to imatinib and may not have received additional systemic therapy for GIST.\n- Measurable disease.\n- Must have a life expectancy of more than 3 months and an ECOG performance status of 0-1.\n- Adequate organ function and bone marrow reserve based on laboratory assessments performed at Screening.\n- Must provide a fresh tumor biopsy."}
Exclusion criteria
- {"criterion_text":"- Must not have received the following within the specified time periods prior to the first dose of study drug: 1.Medications, including anticancer therapies, that are known strong or moderate inhibitors or inducers of CYP3A4 or P-glycoprotein (P-gp) including certain herbal medications (eg, St. John's wort): 14 days or 5×the half-life of the medication (whichever is longer). 2. Other anticancer therapies and any investigational therapies with a known safety and PK profile: 14 days or 5×the half-life of the medication (whichever is shorter). 3.Investigational therapies with unknown safety and PK profile: 28 days. If there is enough data on the investigational therapy to assess the risk for drug-drug interactions and late toxicities of prior therapy as low, the Sponsor's Medical Monitor may approve a shorter washout of 14 days. 4.Grapefruit or grapefruit juice: 14 days.\n- Have not recovered from all clinically relevant toxicities from prior therapy.\n- New York Heart Association Class III or IV heart disease, active ischemia, or any other uncontrolled cardiac condition, clinically significant cardiac arrhythmia requiring therapy, uncontrolled hypertension, congestive heart failure, or myocardial infarction within 6 months prior to the first dose of study drug.\n- Symptomatic central nervous system (CNS) metastases or presence of leptomeningeal disease.\n- Malabsorption syndrome.\n- Radiation for indications other than bone disease must have been completed 4 weeks prior to first dose of study drug, unless it consisted of limited field palliative radiation, including whole brain radiation, which must have been completed at least 2 weeks prior to first dose of study drug.\n- Major surgery within 4 weeks of the first dose of study drug.\n- Active HIV, Hepatitis B or Hepatitis C infection."}
Endpoints
Primary endpoints
- {"endpoint_text":"- Efficacy: ORR based on Investigator assessment, which is defined as the proportion of participants with a best overall response of confirmed CR or confirmed PR per the mRECIST","definition_or_measurement_approach":"Defined as the proportion of participants with a best overall response of confirmed CR or confirmed PR per the mRECIST (investigator assessment)."}
Secondary endpoints
- {"endpoint_text":"- Efficacy: DOR, DCR at 16, 24, and 32 weeks, Time to response, PFS, OS.","definition_or_measurement_approach":"DOR, DCR at 16/24/32 weeks, time to response, PFS and OS as standard efficacy measures (no further definition provided in the record)."}
- {"endpoint_text":"- Safety: TEAEs, SAEs, TEAEs leading to dose reduction, interruption, or discontinuation of any/all study drug(s).","definition_or_measurement_approach":"Assessment of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and TEAEs causing dose modification or discontinuation (standard safety reporting; no further detail provided)."}
- {"endpoint_text":"- Pharmacokinetics: PK endpoints will be evaluated for DCC-3116, ripretinib, and DP-5439. These PK parameters, if determinable, may include tmax, Cmax, Cmin, AUC.","definition_or_measurement_approach":"PK parameters for DCC-3116, ripretinib and DP-5439 may include Tmax, Cmax, Cmin and AUC if determinable."}
Recruitment
- Planned Sample Size
- 87
- Recruitment Window Months
- 43
- Consent Approach
- Informed consent is obtained from adult participants (participants must be ≥18 years). Subject information and informed consent form documents (SIS and ICF) are available in multiple languages as provided in the documents list (English, Dutch, French, Spanish, Portuguese, Greek, Italian). Consent is provided by the participant; study contact for trial information: clinicaltrials@deciphera.com.
Geography
- Total Number Of Sites
- 18
- Total Number Of Participants
- 87
Germany
- Earliest CTIS Part Ii Submission Date
- 03-04-2025
- Latest Decision Or Authorization Date
- 13-01-2026
- Processing Time Days
- 285
- Number Of Sites
- 2
- Number Of Participants
- 12
Sites
- Site Name
- University Medical Center Hamburg-Eppendorf
- Department Name
- Zentrum für Onkologie II. Medizinische Klinik und Poliklinik
- Principal Investigator Name
- Jana Käthe Striefler
- Principal Investigator Email
- j.striefler@uke.de
- Contact Person Name
- Jana Käthe Striefler
- Contact Person Email
- j.striefler@uke.de
- Site Name
- Universitaetsklinikum Frankfurt AöR
- Department Name
- Medizinische Klink II
- Principal Investigator Name
- Marit Ahrens
- Principal Investigator Email
- m.ahrens@med.uni-frankfurt.de
- Contact Person Name
- Marit Ahrens
- Contact Person Email
- m.ahrens@med.uni-frankfurt.de
Portugal
- Earliest CTIS Part Ii Submission Date
- 20-02-2025
- Latest Decision Or Authorization Date
- 12-01-2026
- Processing Time Days
- 326
- Number Of Sites
- 1
- Number Of Participants
- 6
Sites
- Site Name
- Instituto Portugues De Oncologia Do Porto Francisco Gentil E.P.E.
- Department Name
- Onco-Hematologia
- Principal Investigator Name
- Miguel Abreu
- Principal Investigator Email
- antonio.m.abreu@ipoporto.min-saude.pt
- Contact Person Name
- Miguel Abreu
- Contact Person Email
- antonio.m.abreu@ipoporto.min-saude.pt
Netherlands
- Earliest CTIS Part Ii Submission Date
- 02-04-2025
- Latest Decision Or Authorization Date
- 12-01-2026
- Processing Time Days
- 285
- Number Of Sites
- 2
- Number Of Participants
- 12
Sites
- Site Name
- Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting
- Department Name
- Oncology
- Principal Investigator Name
- Neeltje Steeghs
- Principal Investigator Email
- n.steeghs@nki.nl
- Contact Person Name
- Neeltje Steeghs
- Contact Person Email
- n.steeghs@nki.nl
- Site Name
- Radboud universitair medisch centrum Stichting
- Department Name
- Oncology
- Principal Investigator Name
- Ingrid Desar
- Principal Investigator Email
- ingrid.desar@radboudumc.nl
- Contact Person Name
- Ingrid Desar
- Contact Person Email
- ingrid.desar@radboudumc.nl
Spain
- Earliest CTIS Part Ii Submission Date
- 17-03-2025
- Latest Decision Or Authorization Date
- 16-01-2026
- Processing Time Days
- 305
- Number Of Sites
- 4
- Number Of Participants
- 15
Sites
- Site Name
- Hospital Clinico San Carlos
- Department Name
- Oncology
- Principal Investigator Name
- Gloria Marquina Ospina
- Principal Investigator Email
- gloria.marquina@salud.madrid.org
- Contact Person Name
- Gloria Marquina Ospina
- Contact Person Email
- gloria.marquina@salud.madrid.org
- Site Name
- Bellvitge University Hospital
- Department Name
- Oncology
- Principal Investigator Name
- Laura Jimenez Colomo
- Principal Investigator Email
- ljcolomo@iconcologia.net
- Contact Person Name
- Laura Jimenez Colomo
- Contact Person Email
- ljcolomo@iconcologia.net
- Site Name
- Hospital Universitario Ramon Y Cajal
- Department Name
- Oncology
- Principal Investigator Name
- Maria Angeles Vaz Salgado
- Principal Investigator Email
- mavaz4@gmail.com
- Contact Person Name
- Maria Angeles Vaz Salgado
- Contact Person Email
- mavaz4@gmail.com
- Site Name
- University Hospital Virgen Del Rocio S.L.
- Department Name
- Oncology
- Principal Investigator Name
- Maria Pilar Sancho Marquez
- Principal Investigator Email
- sanchomarquez@gmail.com
- Contact Person Name
- Maria Pilar Sancho Marquez
- Contact Person Email
- sanchomarquez@gmail.com
Denmark
- Earliest CTIS Part Ii Submission Date
- 02-04-2025
- Latest Decision Or Authorization Date
- 12-01-2026
- Processing Time Days
- 285
- Number Of Sites
- 1
- Number Of Participants
- 6
Sites
- Site Name
- Aarhus University Hospital
- Department Name
- Dep. of Oncology
- Principal Investigator Name
- Ninna Aggerholm Pedersen
- Principal Investigator Email
- ninnpede@rm.dk
- Contact Person Name
- Ninna Aggerholm Pedersen
- Contact Person Email
- ninnpede@rm.dk
France
- Earliest CTIS Part Ii Submission Date
- 26-02-2025
- Latest Decision Or Authorization Date
- 18-02-2026
- Processing Time Days
- 357
- Number Of Sites
- 4
- Number Of Participants
- 18
Sites
- Site Name
- Institut De Cancerologie De L Ouest
- Department Name
- Oncologie médicale
- Principal Investigator Name
- Emmanuelle BOMPAS
- Principal Investigator Email
- emmanuelle.bompas@ico.unicancer.fr
- Contact Person Name
- Emmanuelle BOMPAS
- Contact Person Email
- emmanuelle.bompas@ico.unicancer.fr
- Site Name
- Assistance Publique Hopitaux De Paris
- Department Name
- Service de gastro-entérologie et d'oncologie digestive
- Principal Investigator Name
- Widad LAHLOU
- Principal Investigator Email
- widad.lahlou@aphp.fr
- Contact Person Name
- Widad LAHLOU
- Contact Person Email
- widad.lahlou@aphp.fr
- Site Name
- Centre Oscar Lambret
- Department Name
- Oncologie médicale
- Principal Investigator Name
- Loic LEBELLEC
- Principal Investigator Email
- l-lebellec@o-lambret.fr
- Contact Person Name
- Loic LEBELLEC
- Contact Person Email
- l-lebellec@o-lambret.fr
- Site Name
- Institut Curie
- Department Name
- Oncologie médicale
- Principal Investigator Name
- Clement BONNET
- Principal Investigator Email
- clement.bonnet@curie.fr
- Contact Person Name
- Clement BONNET
- Contact Person Email
- clement.bonnet@curie.fr
Greece
- Earliest CTIS Part Ii Submission Date
- 06-01-2025
- Latest Decision Or Authorization Date
- 06-04-2026
- Processing Time Days
- 455
- Number Of Sites
- 1
- Number Of Participants
- 3
Sites
- Site Name
- Genesis Idiotiki Geniki Maieftiki Gynaikologiki Kliniki S.A.
- Department Name
- Pathological Oncology
- Principal Investigator Name
- Ioannis Boukovinas
- Principal Investigator Email
- ibouk@otenet.gr
- Contact Person Name
- Ioannis Boukovinas
- Contact Person Email
- ibouk@otenet.gr
Italy
- Earliest CTIS Part Ii Submission Date
- 14-03-2025
- Latest Decision Or Authorization Date
- 28-04-2026
- Processing Time Days
- 410
- Number Of Sites
- 3
- Number Of Participants
- 15
Sites
- Site Name
- Istituto Europeo Di Oncologia S.r.l.
- Department Name
- Oncology
- Principal Investigator Name
- Giovanna Roberta Sanfilippo
- Principal Investigator Email
- roberta.sanfilippo@ieo.it
- Contact Person Name
- Giovanna Roberta Sanfilippo
- Contact Person Email
- roberta.sanfilippo@ieo.it
- Site Name
- Azienda Ospedaliero Universitaria Careggi
- Department Name
- Oncology
- Principal Investigator Name
- Lorenzo Antonuzzo
- Principal Investigator Email
- antonuzzol@aou-careggi.toscana.it
- Contact Person Name
- Lorenzo Antonuzzo
- Contact Person Email
- antonuzzol@aou-careggi.toscana.it
- Site Name
- IRCCS Ospedale Policlinico San Martino
- Department Name
- Oncology
- Principal Investigator Name
- Daniela Comandini
- Principal Investigator Email
- danila.comandini@hsanmartino.it
- Contact Person Name
- Daniela Comandini
- Contact Person Email
- danila.comandini@hsanmartino.it
Sponsor
Primary sponsor
- Full Name
- Deciphera Pharmaceuticals Inc.
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- United States
Contract research organisations
- Name
- IQVIA Limited
- Responsibilities
- codes: [1,12,13,2,5]; email: eu_clinical_trials_information@iqvia.com
- Name
- Fortrea Inc.
- Responsibilities
- codes: [8]; email: SEAIntake@fortrea.com
- Name
- Icon Clinical Research Limited
- Responsibilities
- codes: [4]; email: labsitehelp@iconplc.com
- Name
- PPD Development LP
- Responsibilities
- codes: [15]; value: PK analytical lab; email: Chelsea.Arthurs@ppd.com
Third parties
- {"country":"United States","full_name":"Kcas LLC","duties_or_roles":"codes: [4]; email: TMM@kcasbio.com","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Fortrea Inc.","duties_or_roles":"codes: [8]; email: SEAIntake@fortrea.com","organisation_type":"Pharmaceutical company"}
- {"country":"United Kingdom","full_name":"IQVIA Limited","duties_or_roles":"codes: [1,12,13,2,5]; email: eu_clinical_trials_information@iqvia.com","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Unisphere Travel Ltd. Inc.","duties_or_roles":"codes: [15]; value: Patient travel; email: ksteichen@colpittsclinical.com","organisation_type":"Non-Pharmaceutical company"}
- {"country":"Ireland","full_name":"Icon Clinical Research Limited","duties_or_roles":"codes: [4]; email: labsitehelp@iconplc.com","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Imaging Endpoints II LLC","duties_or_roles":"codes: [15]; value: Imaging; email: aseaney@imagingendpoints.com","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Guardant Health Inc.","duties_or_roles":"codes: [4]; email: adenman@guardanthealth.com","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"United States","full_name":"Eclinical Solutions LLC","duties_or_roles":"codes: [15,6]; values: Elluminate; email: kkonkey@eclinicalsol.com","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Greenphire LLC","duties_or_roles":"codes: [15]; value: Patient reimbursements; email: clientdeliveryrequest@greenphire.com","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United States","full_name":"Suvoda LLC","duties_or_roles":"codes: [3]; email: support@suvoda.com","organisation_type":"Non-Pharmaceutical company"}
- {"country":"Germany","full_name":"PCI Pharma Services Germany GmbH","duties_or_roles":"codes: [14]; email: sasha.brough@pci.com","organisation_type":"Pharmaceutical company"}
- {"country":"United Kingdom","full_name":"Vivos Technology Limited","duties_or_roles":"codes: [15]; value: Independent Data Monitoring Committee; email: Relana.pinkerton@phastar.com","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United States","full_name":"PPD Development LP","duties_or_roles":"codes: [15]; value: PK analytical lab; email: Chelsea.Arthurs@ppd.com","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Neogenomics Laboratories Inc.","duties_or_roles":"codes: [15]; value: tumor tissue analysis lab; email: pharmaservices@neogenomics.com","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"Greece","full_name":"IQVIA RDS Hellas Single Member S.A.","duties_or_roles":"codes: [1,12]; email: EUCTR_Greece@iqvia.com","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Eresearchtechnology Inc.","duties_or_roles":"codes: [15]; value: ePRO; email: customercare@ert.com","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Llx Solutions LLC","duties_or_roles":"codes: [10]; email: LLX.USA@llxsolutions.com","organisation_type":"Pharmaceutical company"}
Investigational products
- Investigational Product Name
- DCC-3116
- Active Substance
- DCC-3116
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- ORAL
- Authorisation Status
- Not authorised
- Investigational Product Name
- QINLOCK 50 mg tablets
- Active Substance
- RIPRETINIB
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- ORAL
- Authorisation Status
- Authorised (marketing authorisation EU/1/21/1569/001)
- Orphan Designation
- Yes
- Combination Treatment
- Yes
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