Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-31 @ 8:56 AM
Study NCT ID:
NCT07485569
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-20
First Post:
2023-07-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Drug Repurposing in Thyroid Carcinoma: a Feasibility Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013964', 'term': 'Thyroid Neoplasms'}, {'id': 'D065646', 'term': 'Thyroid Carcinoma, Anaplastic'}], 'ancestors': [{'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D013959', 'term': 'Thyroid Diseases'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-06-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2027-09-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-16', 'studyFirstSubmitDate': '2023-07-18', 'studyFirstSubmitQcDate': '2026-03-16', 'lastUpdatePostDateStruct': {'date': '2026-03-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Feasibility', 'timeFrame': '12 weeks', 'description': 'Number and proportion of enrolled patients who initiate study treatment.'}, {'measure': 'Safety', 'timeFrame': '12 weeks', 'description': 'Number and proportion of patients who experience treatment-related adverse events (CTCAE v5.0).'}], 'secondaryOutcomes': [{'measure': 'Preliminary efficacy', 'timeFrame': '12 weeks', 'description': 'Disease control rate (DCR) at 3 months, defined as the number and proportion of patients achieving stable disease (SD), partial response (PR), or complete response (CR), according to RECIST 1.1.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Drug repurposing', 'Thyroid cancer', 'Network pharmacology', 'Personalized therapy'], 'conditions': ['Thyroid Cancer Stage IV', 'Anaplastic Thyroid Cancer', 'Differentiated Thyroid Cancer', 'Poorly Differentiated Thyroid Carcinoma']}, 'descriptionModule': {'briefSummary': 'Rationale Patients with advanced thyroid cancer often have very few treatment options, and standard therapies usually cannot cure the disease. Some types grow and spread quickly and do not respond to surgery and radioactive iodine. For patients with other types, existing drugs may slow the disease but can cause strong side effects, limiting their usefulness. This study is testing a new personalized approach that uses genetic tumor information to identify combinations of existing approved drugs that may work better together. The idea is that targeting several connected networks in the tumor at the same time may be more effective than standard treatments that focus on a single target.\n\nObjective The main objective is to study if it is feasible and safe to give patients individualized drug combinations selected based on their tumor genetic profile. The secondary objective is to find out whether these treatments can help control the growth of the patient tumors or stop them from getting worse. Main trial endpoints\n\n* Feasibility: How many patients can start the individualized treatment.\n* Safety: How many patients experience side effects from the treatment. Secondary trial endpoints\n* Effectiveness: How many patients achieve disease control (stable disease, partial response, or complete response) after three months of treatment.\n* Other outcomes (exploratory): additional feasibility outcomes, patient-and caregiver-reported outcomes, other effectivity outcomes, and biological signals in the blood. Trial design This is an exploratory, single-arm phase I umbrella trial. Each patient receives a personalized treatment based on the genetic profile of their tumor. The study focuses on understanding feasibility and safety. Each participant will be in the study for approximately 4 months. The first month is used to examine the tumor of the patient and select the best personalized treatment. Once the treatment is chosen and both the patient and their doctor agree, the patient will receive the treatment for three months. During treatment, patients will have regular check-ups, blood tests, scans, and questionnaires to monitor safety and see how well the treatment is controlling the tumor.\n\nTrial population Inclusion criteria: Up to 10 adult patients (over 18 years) with advanced or metastatic thyroid cancer who have no other standard treatment options. Exclusion criteria: Pregnant women and patients eligible for urgent local treatments.\n\nInterventions\n\n* Tumor samples (from surgery or biopsy) will be analyzed to identify genetic features and potential drug targets.\n* A multidisciplinary study board will select an individualized combination of approved drugs that are expected to be safe and potentially effective.\n* Patients and their treating physicians will decide together whether to start the treatment.\n* Monitoring during treatment includes physical exams, blood tests, imaging scans, and patient questionnaires about symptoms and quality of life'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with locally advanced or metastatic TC (such as ATC, PDTC, and RAI refractory DTC progressive under treatment with multikinase inhibitors) for whom no approved conventional treatments are available.\n* Prior anticancer treatment-related toxicities resolved to Grade ≤1 (CTCAE v5.0).\n* Measurable disease per RECIST 1.1\n* ECOG performance status ≤ 2\n* Negative pregnancy test within 7 days prior to starting the study in women of childbearing potential and adequate use of contraception.\n\nExclusion Criteria:\n\n* Inability to provide informed consent\n* Inability to obtain a (new) biopsy for molecular profiling\n* Pregnancy or breastfeeding.\n* Other active malignancies requiring therapy.\n* Neutropenia (ANC \\< 1.5 × 10⁹/L).\n* Severe uncontrolled medical conditions (renal, cardiac, liver, respiratory).'}, 'identificationModule': {'nctId': 'NCT07485569', 'acronym': 'REPOTHYROID-II', 'briefTitle': 'Drug Repurposing in Thyroid Carcinoma: a Feasibility Trial', 'organization': {'class': 'OTHER', 'fullName': 'Radboud University Medical Center'}, 'officialTitle': 'Network Pharmacology-based Personalized Drug Repurposing in Thyroid Carcinoma: a Pilot Feasibility Trial', 'orgStudyIdInfo': {'id': '2023-507214-28-00'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Personalized network-pharmacology-based combination therapy', 'description': 'Patients with advanced thyroid cancer undergo tumor molecular profiling using to identify personalized drug repurposing treatments. All drugs are administered at authorized therapeutic doses according to the summary of product characteristics. Treatment regimens vary between patients depending on the identified molecular profile.', 'interventionNames': ['Combination Product: Personalised treatment']}], 'interventions': [{'name': 'Personalised treatment', 'type': 'COMBINATION_PRODUCT', 'description': 'The therapy will consist of (one or more) drugs listed below:\n\n* Tamoxifen\n* Selpercatinib\n* Indomethacin\n* Niclosamide\n* Sunitinib\n* Dabrafenib\n* Trametinib\n* Erlotinib\n* Simvastatin\n* Temozolomide', 'armGroupLabels': ['Personalized network-pharmacology-based combination therapy']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Romana Netea-Maier, Prof. Dr.', 'role': 'CONTACT', 'email': 'romana.netea-maier@radboudumc.nl', 'phone': '+31243614599'}], 'overallOfficials': [{'name': 'Romana Netea-Maier', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Radboud University Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Radboud University Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Maastricht University', 'class': 'OTHER'}, {'name': 'EU Horizon', 'class': 'UNKNOWN'}, {'name': 'Horizon Europe', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}