[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"primary-cns-tumors\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:primary-cns-tumors":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,40],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":34,"leadSponsor":36,"locationsCount":39},"100647923","the-added-value-of-tissue-or-liquid-biopsy-ngs-profiling-in-advanced-solid-tumor-treatment-decisions-100647923",false,"NCT07713550","The Added Value of Tissue or Liquid Biopsy NGS Profiling in Advanced Solid Tumor Treatment Decisions.","The Added Value of Tissue or Liquid Biopsy NGS Profiling in Advanced Solid Tumor Treatment Decisions: The Belgian PRECISION Study of the BSMO in Collaboration With the Cancer Center of Sciensano.","GeNeo2","Inclusion Criteria:\n\n1. Adult patient (minimum 18 years) able to provide written informed consent for GeNeo 2.0.\n2. ECOG Performance status ≤2\n3. Patients with advanced solid tumors or primary CNS tumors that are candidates for systemic anticancer therapy and open for enrollment in a potential downstream therapeutic trial. Enrollment in early treatment lines is strongly encouraged Tumor cohorts of breast cancer and lung cancer will be prioritized, with a minimum cap of 100 for each tumor type. Recruitment for all other tumor type cohorts will be capped at a maximum of 40 patients per tumor type. The MTB can decide on prematurely closing or extending tumor type cohorts based on treatment recommendations, clinical trial landscape or downstream treatment options. Enrollment of patients early in the advanced treatment setting will be strongly encouraged.\n4. Patients should have archived tissue available from a metastatic (preferred) or primary lesion biopsy for comprehensive profiling. The tissue should not be more than 2 years-old and fixed in 10% neutral buffered formalin. Tumor cell content should be \\>20%\n\nExclusion Criteria:\n\n1. Life expectancy of ≤12 weeks according to the local investigator\n2. Clinically significant hematopoietic, renal and\u002For hepatic dysfunction, according to the local investigator, which would make them ineligible for MGTO therapy\n3. Patients unwilling to comply with GeNeo 2.0 protocol data collection, data sharing and other study procedures\n4. Patients unwilling to provide informed consent and comply with study procedures.","ALL","18 Years",{"count":20,"type":21},550,"ESTIMATED","OBSERVATIONAL","A total of 550 patients with metastatic solid tumors or primary CNS malignancy will be recruited on a first come first serve basis at one of the 14 participating centers : UZL, UZG, Imelda, ZAZ, AZ Klina, CHU Liège, GHdC, CHU UCL Namur, IJB, UZB, CUSL, UZA, VITAZ and Jessa Zh..\n\n\\> 500 patients with tissue available will undergo CGP centrally at UZ Leuven (Roche AVENIO Tumor Tissue CGP kits, Novaseq platform).\n\n\\> 50 patients without tissue available will undergo liquid biopsy testing at Foundation Medicine (FoundationOne Liquid CDx).\n\nThe sequencing data generated by UZ Leuven laboratory will then be further analysed (secondary and tertiary analysis) by one of the eight laboratories participating in the study: UZL, UZG, IJB, CUSL, IPG, UZA, Jessa zh. and CHU Liège.",[25,26],"Advanced Solid Tumor Cancer","Primary CNS Tumors","RECRUITING","2026-07-16",{"date":30,"type":31},"2026-07-20","ACTUAL",{"date":33,"type":31},"2025-10-22",{"date":35,"type":21},"2029-04",{"name":37,"class":38},"The Belgian Society of Medical Oncology","OTHER",14,{"id":41,"slug":42,"hasResults":11,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":4,"eligibilityCriteria":46,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":47,"enrollmentInfo":48,"targetDuration":4,"studyType":50,"phases":51,"briefSummary":54,"conditions":55,"keywords":59,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":85},"100369766","phase-1-a-study-of-repotrectinib-in-pediatric-and-young-adult-subjects-harboring-alk-ros1-or-ntrk1-3-alterations-100369766","NCT04094610","A Study of Repotrectinib in Pediatric and Young Adult Subjects Harboring ALK, ROS1, OR NTRK1-3 Alterations","A Phase 1\u002F2, Open-Label, Safety, Tolerability, Pharmacokinetics, and Anti-Tumor Activity Study of Repotrectinib in Pediatric and Young Adult Subjects With Advanced or Metastatic Malignancies Harboring ALK, ROS1, NTRK1-3 Alterations","Key Inclusion Criteria:\n\n1. Documented genetic ROS1 point mutation, fusion, or amplification or NTRK1-3 fusion as identified by local testing in a Clinical Laboratory Improvement Amendments (CLIA) laboratory in the US or equivalently accredited diagnostic lab outside the United States (US) is required.\n2. Phase 1: Age \\\u003C12 years; Phase 2: Age 12- 25 years\n3. Prior cytotoxic chemotherapy is allowed.\n4. Prior immunotherapy is allowed.\n5. Resolution of all acute toxic effects (excluding alopecia) of any prior anti-cancer therapy to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4.03 Grade less than or equal to 1.\n6. All subjects must have measurable disease by RECIST v1.1 or Response Assessment in Neuro-Oncology (RANO) criteria at time of enrollment.\n7. Subjects with a primary CNS tumor or CNS metastases must be neurologically stable on a stable or decreasing dose of steroids for at least 7 days prior to enrollment.\n8. Subjects must have a Lansky (\\\u003C 16 years) or Karnofsky (≥ 16 years) score of at least 50.\n9. Life expectancy greater than or equal to 12 weeks, in the investigator's opinion.\n10. Adequate hematologic, renal and hepatic function.\n\nPhase 2 Inclusion Criteria:\n\n1. Cohort Specific Inclusion Criteria:\n\n   * Cohort 1: Subjects with NTRK fusion gene positive (NTRK+) advanced solid tumors (including primary CNS tumors), that are tropomyosin receptor kinase (TRK) TKI naïve;\n   * Cohort 2: subjects with NTRK+ advanced solid tumors (including primary CNS tumors), that are TRK TKI pre-treated;\n   * Cohort 3: subjects with advanced solid tumors with ROS1 gene fusions or other ROS1 aberrations (including amplifications and point mutations) with measurable disease.\n2. Subjects in Cohorts 1 and 2 must have prospectively confirmed measurable disease by BICR prior to enrollment.\n\nKey Exclusion Criteria (Phase 1 and Phase 2):\n\n1. Subjects with neuroblastoma with only bone marrow disease evaluable by bone marrow aspiration only.\n2. Major surgery within 14 days (2 weeks) of start of repotrectinib treatment. Central venous access (Broviac, Mediport, etc.) placement does not meet criteria for major surgery.\n3. Known active infections requiring ongoing treatment (bacterial, fungal, viral including HIV positivity).\n4. Gastrointestinal disease (e.g., Crohn's disease, ulcerative colitis, or short gut syndrome) or other malabsorption syndromes that would impact drug absorption.\n5. Any of the following cardiac criteria:\n\n   * Mean resting corrected QT interval (ECG interval measured from the onset of the QRS complex to the end of the T wave) for heart rate (QTc) \\> 480 msec obtained from three ECGs, using the screening clinic ECG machine-derived QTc value\n   * Any clinically important abnormalities in rhythm, conduction, or morphology of resting ECG (e.g., complete left bundle branch block, third degree heart block, second degree heart block, PR interval \\> 250 msec)\n   * Any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as heart failure, congenital long QT syndrome, family history of long QT syndrome, or any concomitant medication known to prolong the QT interval\n6. Peripheral neuropathy of CTCAE ≥grade 2.\n7. Subjects being treated with or anticipating the need for treatment with strong CYP3A4 inhibitors or inducers.\n8. Any potential allergies to repotrectinib and\u002For its excipients.","25 Years",{"count":49,"type":21},75,"INTERVENTIONAL",[52,53],"PHASE1","PHASE2","Phase 1 will evaluate the safety and tolerability at different dose levels of repotrectinib in pediatric and young adult subjects with advanced or metastatic malignancies harboring anaplastic lymphoma kinase (ALK), receptor tyrosine kinase encoded by the gene ROS1 (ROS1), or neurotrophic receptor kinase genes encoding TRK kinase family (NTRK1-3) alterations to estimate the Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD) and select the Pediatric Recommended Phase 2 Dose (RP2D).\n\nPhase 2 will determine the anti-tumor activity of repotrectinib in pediatric and young adult subjects with advanced or metastatic malignancies harboring ROS1 or NTRK1-3 alterations.",[56,57,58,26],"Locally Advanced Solid Tumors","Metastatic Solid Tumors","Lymphoma",[60,61,62,63,64,65,66,67,68,69,70,71,72,73,74],"ALK","ROS1","NTRK1-3","Primary CNS tumor","anaplastic large cell lymphoma","metastatic solid tumor","advanced solid tumor","sarcoma","infantile fibrosarcoma","glioblastoma","soft tissue schwannoma","solitary fibrous tumor","glioma","inflammatory myofibroblastic tumor","pediatric","2025-11-18",{"date":77,"type":31},"2025-11-19",{"date":79,"type":31},"2020-03-12",{"date":81,"type":21},"2027-09-30",{"name":83,"class":84},"Turning Point Therapeutics, Inc.","INDUSTRY",68]