{"ok":true,"data":{"subject":{"kind":"trial","nctId":"NCT07477457","title":"A Study of Gefitinib, Trametinib, Disulfiram, and Sunitinib in Addition to Standard Chemotherapy in People With Osteosarcoma","sponsor":"Memorial Sloan Kettering Cancer Center","phases":["PHASE2"],"status":"RECRUITING","indication":{"slug":"osteosarcoma","name":"Osteosarcoma"},"disease":"osteosarcoma"},"rows":[{"n":1,"question":"Is the biology right?","flags":[{"id":"somatic_driver","label":"Somatic driver evidence","value":"yes","detail":"EGFR, MAP2K2, MAP2K1, ALDH2, CSF1R, KIT, FLT3 in osteosarcoma","rule":"Open Targets has somatic-mutation evidence for the target in this cancer","source":{"label":"Open Targets: EGFR in osteosarcoma","url":"https://platform.opentargets.org/evidence/ENSG00000146648/MONDO_0009807","date":"2026-11-11T17:42:35.151Z"},"context":[{"figure":"2.3× relative success for targets with somatic (IntOGen) support in oncology","dataset":"Minikel et al., Nature 2024","years":"drug programs to 2023","caveat":"A ratio between groups, not a probability for this program; mostly phase 2 to 3."}]},{"id":"human_genetic","label":"Human genetic evidence","value":"yes","detail":"EGFR: somatic; MAP2K2: somatic; MAP2K1: somatic; ALDH2: somatic; CSF1R: somatic; KIT: somatic; FLT3: somatic","rule":"Any germline or somatic human genetic evidence for the target in this cancer, counted apart from animal-model and literature evidence","source":{"label":"Open Targets: EGFR in osteosarcoma","url":"https://platform.opentargets.org/evidence/ENSG00000146648/MONDO_0009807","date":"2026-11-11T17:42:35.151Z"},"context":[{"figure":"2.6× relative probability of success, phase 1 to launch, with human genetic support","dataset":"Minikel et al., Nature 2024","years":"drug programs to 2023","caveat":"All therapy areas, mostly germline evidence; not a probability for this program."}]},{"id":"pediatric_target","label":"Pediatric target","value":"yes","detail":"EGFR, MAP2K2, MAP2K1, CSF1R, KIT, FLT3 on the FDA list","rule":"Target is on FDA's Pediatric Molecular Target List (relevant targets); membership alone neither requires nor waives a study","source":{"label":"FDA Pediatric Molecular Target List (Listed as February 2026 on the FDA Pediatric Oncology page; the file served is 9.7.22_the_relevant_molecular_target_list.xlsx, whose Summary of Changes sheet is headed 'SEPTEMBER 2022 UPDATE' (footnote date 2022-09-01))","url":"https://www.fda.gov/media/191157/download?attachment","date":"2026-11-11T07:05:03Z"},"context":[]},{"id":"haematologic","label":"Haematologic cancer","value":"no","detail":"Solid tumour","rule":"From the indication, or the registry conditions when no indication matches","source":{"label":"ClinicalTrials.gov NCT07477457","url":"https://clinicaltrials.gov/study/NCT07477457","date":"2026-11-11T17:42:35.151Z"},"context":[{"figure":"Likelihood of approval from phase 1: 7.5% haematologic vs 4.6% solid","dataset":"BIO / Informa / QLS 2021","years":"2011–2020","caveat":"Population-level, not a prediction."}]}],"facts":[{"label":"Background therapy","text":"Methotrexate, Doxorubicin, Ifosfamide: standard agents, not counted in these flags."},{"label":"EGFR (via Gefitinib)","text":"Evidence types in osteosarcoma: literature, somatic_mutation, clinical; literature listed separately from human genetics. Datasources: cancer_gene_census, europepmc, clinical_precedence.","source":{"label":"Open Targets: EGFR in osteosarcoma","url":"https://platform.opentargets.org/evidence/ENSG00000146648/MONDO_0009807","date":"2026-11-11T17:42:35.151Z"}},{"label":"MAP2K2 (via Trametinib)","text":"Evidence types in osteosarcoma: literature, somatic_mutation, clinical; literature listed separately from human genetics. Datasources: cancer_gene_census, clinical_precedence, europepmc.","source":{"label":"Open Targets: MAP2K2 in osteosarcoma","url":"https://platform.opentargets.org/evidence/ENSG00000126934/MONDO_0009807","date":"2026-11-11T17:42:35.151Z"}},{"label":"MAP2K1 (via Trametinib)","text":"Evidence types in osteosarcoma: literature, somatic_mutation, clinical; literature listed separately from human genetics. Datasources: cancer_gene_census, europepmc, clinical_precedence.","source":{"label":"Open Targets: MAP2K1 in osteosarcoma","url":"https://platform.opentargets.org/evidence/ENSG00000169032/MONDO_0009807","date":"2026-11-11T17:42:35.151Z"}},{"label":"ALDH2 (via Disulfiram)","text":"Evidence types in osteosarcoma: literature, somatic_mutation, clinical; literature listed separately from human genetics. Datasources: intogen, cancer_gene_census, clinical_precedence, europepmc.","source":{"label":"Open Targets: ALDH2 in osteosarcoma","url":"https://platform.opentargets.org/evidence/ENSG00000111275/MONDO_0009807","date":"2026-11-11T17:42:35.151Z"}},{"label":"CSF1R (via Sunitinib)","text":"Evidence types in osteosarcoma: literature, somatic_mutation, clinical; literature listed separately from human genetics. Datasources: cancer_gene_census, clinical_precedence, europepmc.","source":{"label":"Open Targets: CSF1R in osteosarcoma","url":"https://platform.opentargets.org/evidence/ENSG00000182578/MONDO_0009807","date":"2026-11-11T17:42:35.151Z"}},{"label":"KIT (via Sunitinib)","text":"Evidence types in osteosarcoma: literature, somatic_mutation, clinical; literature listed separately from human genetics. Datasources: cancer_gene_census, clinical_precedence, europepmc.","source":{"label":"Open Targets: KIT in osteosarcoma","url":"https://platform.opentargets.org/evidence/ENSG00000157404/MONDO_0009807","date":"2026-11-11T17:42:35.151Z"}},{"label":"FLT3 (via Sunitinib)","text":"Evidence types in osteosarcoma: literature, somatic_mutation, clinical; literature listed separately from human genetics. Datasources: cancer_gene_census, clinical_precedence, europepmc.","source":{"label":"Open Targets: FLT3 in osteosarcoma","url":"https://platform.opentargets.org/evidence/ENSG00000122025/MONDO_0009807","date":"2026-11-11T17:42:35.151Z"}}],"pending":[{"what":"Normal-tissue expression in vital organs","source":"Human Protein Atlas (ticket 36)"},{"what":"Pan-essential in cell lines","source":"DepMap (ticket 36)"},{"what":"Approved drug on this target","source":"Drugs@FDA (ticket 30)"}]},{"n":2,"question":"Can the result be trusted?","flags":[{"id":"randomised","label":"Randomised","value":"no","detail":"Non-randomised","rule":"Registry allocation field","source":{"label":"ClinicalTrials.gov NCT07477457","url":"https://clinicaltrials.gov/study/NCT07477457","date":"2026-11-11T17:42:35.151Z"},"context":[]},{"id":"small_denominator","label":"Small denominator","value":"no","detail":"45 planned; each patient moves a rate by 100 ÷ 45 = 2.2 points","rule":"Enrolment under 30; the arithmetic is shown, not a benchmark","source":{"label":"ClinicalTrials.gov NCT07477457","url":"https://clinicaltrials.gov/study/NCT07477457","date":"2026-11-11T17:42:35.151Z"},"context":[]},{"id":"primary_os","label":"Primary endpoint is overall survival","value":"yes","detail":"12-month progression free survival (PFS) (cohort 1); 24-month overall survival (OS) (cohort 2)","rule":"A registered primary outcome measure names overall survival","source":{"label":"ClinicalTrials.gov NCT07477457","url":"https://clinicaltrials.gov/study/NCT07477457","date":"2026-11-11T17:42:35.151Z"},"context":[]},{"id":"results_overdue","label":"Results overdue","value":"no","detail":"Primary completion expected 2028-03; not yet due","rule":"Primary completion (actual) more than 12 months ago and no results posted to the registry","source":{"label":"ClinicalTrials.gov NCT07477457","url":"https://clinicaltrials.gov/study/NCT07477457","date":"2026-11-11T17:42:35.151Z"},"context":[]}],"facts":[],"pending":[{"what":"Treated and evaluable counts, assessor, confirmed response, follow-up and data cutoff","source":"Readout extraction (ticket 32)"},{"what":"Primary endpoint changed between registry versions","source":"Registry versions in the store (ticket 32)"}]},{"n":3,"question":"What must it beat?","flags":[],"facts":[],"pending":[{"what":"Control-arm result and approved therapies for the same segment, with label links","source":"Drugs@FDA, FDA labels and readouts (tickets 30, 32)"}]},{"n":4,"question":"Too crowded, or too late?","flags":[],"facts":[{"label":"Stopped on this target","text":"181 terminated, withdrawn or suspended trials of drugs against EGFR; 20 give no reason. Reasons are quoted as the registry gives them on the target page.","source":{"label":"EGFR: what already stopped","url":"/target/ENSG00000146648#stopped","date":"2026-11-11T17:42:35.190Z"}}],"pending":[{"what":"Programs on the target by phase and months behind the leader","source":"Programs and Drugs@FDA (ticket 33)"}]},{"n":5,"question":"Can it be approved, and stay approved?","flags":[{"id":"single_country","label":"Single-country","value":"yes","detail":"All 7 sites in United States","rule":"All listed sites are in one country; the share of US sites is shown","source":{"label":"ClinicalTrials.gov NCT07477457","url":"https://clinicaltrials.gov/study/NCT07477457?tab=locations","date":"2026-11-11T17:42:35.151Z"},"context":[]},{"id":"eu_pip","label":"EU paediatric investigation plan","value":"yes","detail":"EMEA-001177-PIP02-20 (trametinib, Treatment of glioma): P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), 23 Oct 2020; compliance positive 27 Sept 2022; EMEA-000342-PIP01-08-M07 (sunitinib, Treatment of gastro-intestinal stromal tumours): PM: decision on the application for modification of an agreed PIP, 7 May 2018; compliance positive 29 Jun 2018","rule":"An EMA PIP decision (agreement, modification or waiver) lists the drug as its active substance, exact name","source":{"label":"EMA data download (dated snapshot)","url":"https://www.ema.europa.eu/en/documents/report/medicines-output-paediatric_investigation_plans-output-json-report_en.json","date":"2026-11-11T09:12:26Z"},"context":[]},{"id":"eu_orphan","label":"EU orphan designation","value":"yes","detail":"EU/3/20/2374 positive 9 Dec 2020: Treatment of glioma","rule":"An EU orphan designation lists the drug as its active substance (exact name) or belongs to a medicine that does; withdrawn and expired designations are listed with their status","source":{"label":"EMA EU/3/20/2374","url":"https://www.ema.europa.eu/en/medicines/human/orphan-designations/eu-3-20-2374","date":"2026-11-11T09:12:26Z"},"context":[]},{"id":"eu_authorised","label":"Authorised in the EU","value":"yes","detail":"Iressa: authorised since 24 Jun 2009; Sunitinib Accord: authorised since 11 Feb 2021; Mekinist: authorised since 30 Jun 2014; Spexotras: authorised since 5 Jan 2024, orphan medicine; +2 more","rule":"An EMA medicine record lists the drug as its active substance or INN, exact name; national-only authorisations are not in this file","source":{"label":"EMA data download (dated snapshot)","url":"https://www.ema.europa.eu/en/documents/report/medicines-output-medicines_json-report_en.json","date":"2026-11-11T09:12:26Z"},"context":[]},{"id":"fda_orphan","label":"FDA orphan designation","value":"not published","detail":"FDA's orphan designation database turns away automated requests, so this app does not read it; search it by hand at the link","rule":"Would be: an FDA orphan designation names the drug","source":{"label":"FDA orphan designations search","url":"https://www.accessdata.fda.gov/scripts/opdlisting/oopd/","date":""},"context":[]},{"id":"fda_ped_approval","label":"FDA pediatric oncology approval","value":"yes","detail":"Trametinib [Mekinist], 31 Aug 2023: In combination with dabrafenib, for the treatment of adult and pediatric patients 1 year of age and older with unresectable or metastatic solid tumors with BRAF V600E mutation who have progressed following prior treatment and have no satisfactory alternative treatment options; Trametinib [Mekinist], 16 Mar 2023: In combination with dabrafenib, for the treatment of pediatric patients 1 year of age and older with low-grade glioma (LGG) with a BRAF V600E mutation who require systemic therapy","rule":"FDA's Pediatric Oncology Drug Approvals table names the drug","source":{"label":"FDA Pediatric Oncology Drug Approvals (content current as of 2026-03-03)","url":"https://www.fda.gov/about-fda/oncology-center-excellence/pediatric-oncology-drug-approvals","date":"2026-11-11T17:42:35.199Z"},"context":[]},{"id":"studies_under_18","label":"Registered studies open to children","value":"yes","detail":"92 interventional studies of Gefitinib, Trametinib, Disulfiram, Sunitinib include patients under 18; 39 are recruiting, not yet recruiting or active","rule":"The registry's age group includes Child (birth to 17 years), which also counts studies that set no minimum age","source":{"label":"ClinicalTrials.gov search","url":"https://clinicaltrials.gov/search?intr=%22Gefitinib%22+OR+%22Trametinib%22+OR+%22Disulfiram%22+OR+%22Sunitinib%22&aggFilters=ages%3Achild%2CstudyType%3Aint","date":"2026-11-11T17:42:35.207Z"},"context":[]}],"facts":[{"label":"Caveat","text":"Site counts are not patients per country, and trials registered only outside ClinicalTrials.gov are not covered. Where the sites are is a fact about the record, not a judgement of its quality."},{"label":"Rare pediatric disease voucher","text":"FDA, content current as of 29 Apr 2026: “As of February 3, 2026, enactment of the Consolidated Appropriations Act, 2026, the rare pediatric disease PRV program will sunset after September 30, 2029. FDA may not award any PRVs under this program after September 30, 2029.” Voucher sale prices are not shown here; they appear only as company-reported news.","source":{"label":"FDA: Rare Pediatric Disease Designation and Priority Review Voucher Programs","url":"https://www.fda.gov/industry/medical-products-rare-diseases-and-conditions/rare-pediatric-disease-designation-and-priority-review-voucher-programs","date":"2026-11-11"}}],"pending":[{"what":"Precedent approvals for target, modality and endpoint; accelerated-approval status","source":"Drugs@FDA and FDA accelerated-approval tables (ticket 30)"}]},{"n":6,"question":"Can the sponsor finish?","flags":[],"facts":[{"label":"Sponsor","text":"Memorial Sloan Kettering Cancer Center (academic or other)","source":{"label":"ClinicalTrials.gov NCT07477457","url":"https://clinicaltrials.gov/study/NCT07477457","date":"2026-11-11T17:42:35.151Z"}},{"label":"principal investigator","text":"Damon Reed, MD, Memorial Sloan Kettering Cancer Center","source":{"label":"Person page","url":"/person/Damon%20Reed%2C%20MD?ind=osteosarcoma","date":"2026-11-11T17:42:35.151Z"}}],"pending":[{"what":"Filed cash, quarterly spend and the runway arithmetic","source":"SEC XBRL company facts (ticket 37)"},{"what":"Sponsor's completed vs stopped oncology trials and results-reporting record","source":"Registry, by company (ticket 37)"}]}],"limits":"Public records cannot show: sales forecasts; a probability of success for this asset; full deal terms and net prices; FDA designations and action dates before approval (shown only as company-reported); clinical holds unless the company disclosed them; manufacturing; patents on unapproved drugs; whether preclinical findings have been replicated.","sources":[{"label":"ClinicalTrials.gov NCT07477457","url":"https://clinicaltrials.gov/study/NCT07477457","date":"2026-11-11T17:42:35.151Z"},{"label":"Open Targets Platform","url":"https://platform.opentargets.org","date":"2026-11-11T17:42:35.151Z"},{"label":"FDA Pediatric Molecular Target List (Listed as February 2026 on the FDA Pediatric Oncology page; the file served is 9.7.22_the_relevant_molecular_target_list.xlsx, whose Summary of Changes sheet is headed 'SEPTEMBER 2022 UPDATE' (footnote date 2022-09-01))","url":"https://www.fda.gov/media/191157/download?attachment","date":"2026-11-11T07:05:03Z"}]},"source":"ClinicalTrials.gov + Open Targets","fetchedAt":"2026-11-11T17:42:35.146Z"}