{"ok":true,"data":{"subject":{"kind":"trial","nctId":"NCT01345084","title":"Study Comparing Radiation Therapy and Chemotherapy With or Without Nimotuzumab","sponsor":"Eurofarma Laboratorios S.A.","phases":["PHASE3"],"status":"WITHDRAWN","indication":null,"disease":"carcinoma"},"rows":[{"n":1,"question":"Is the biology right?","flags":[{"id":"somatic_driver","label":"Somatic driver evidence","value":"yes","detail":"EGFR in carcinoma","rule":"Open Targets has somatic-mutation evidence for the target in this cancer","source":{"label":"Open Targets: EGFR in carcinoma","url":"https://platform.opentargets.org/evidence/ENSG00000146648/MONDO_0004993","date":"2026-11-11T15:23:02.326Z"},"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","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 carcinoma","url":"https://platform.opentargets.org/evidence/ENSG00000146648/MONDO_0004993","date":"2026-11-11T15:23:02.326Z"},"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 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 NCT01345084","url":"https://clinicaltrials.gov/study/NCT01345084","date":"2026-11-11T15:23:02.326Z"},"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":"EGFR (via Nimotuzumab)","text":"Evidence types in carcinoma: literature, somatic_mutation, clinical; literature listed separately from human genetics. Datasources: cancer_gene_census, europepmc, clinical_precedence.","source":{"label":"Open Targets: EGFR in carcinoma","url":"https://platform.opentargets.org/evidence/ENSG00000146648/MONDO_0004993","date":"2026-11-11T15:23:02.326Z"}}],"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":"yes","detail":"Randomised allocation","rule":"Registry allocation field","source":{"label":"ClinicalTrials.gov NCT01345084","url":"https://clinicaltrials.gov/study/NCT01345084","date":"2026-11-11T15:23:02.326Z"},"context":[]},{"id":"small_denominator","label":"Small denominator","value":"yes","detail":"0 enrolled; each patient moves a rate by 100 ÷ 0 = – points","rule":"Enrolment under 30; the arithmetic is shown, not a benchmark","source":{"label":"ClinicalTrials.gov NCT01345084","url":"https://clinicaltrials.gov/study/NCT01345084","date":"2026-11-11T15:23:02.326Z"},"context":[]},{"id":"primary_os","label":"Primary endpoint is overall survival","value":"yes","detail":"Overall survival","rule":"A registered primary outcome measure names overall survival","source":{"label":"ClinicalTrials.gov NCT01345084","url":"https://clinicaltrials.gov/study/NCT01345084","date":"2026-11-11T15:23:02.326Z"},"context":[]},{"id":"results_overdue","label":"Results overdue","value":"no","detail":"Primary completion expected 2013-11; not yet due","rule":"Primary completion (actual) more than 12 months ago and no results posted to the registry","source":{"label":"ClinicalTrials.gov NCT01345084","url":"https://clinicaltrials.gov/study/NCT01345084","date":"2026-11-11T15:23:02.326Z"},"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":"2026-11-11T15:23:02.333Z"}}],"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 8 sites in Brazil","rule":"All listed sites are in one country; the share of US sites is shown","source":{"label":"ClinicalTrials.gov NCT01345084","url":"https://clinicaltrials.gov/study/NCT01345084?tab=locations","date":"2026-11-11T15:23:02.326Z"},"context":[]},{"id":"eu_pip","label":"EU paediatric investigation plan","value":"no","detail":"No EMA paediatric investigation plan decision names Nimotuzumab","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/3/08/550 positive 3 Jun 2008: Treatment of pancreatic cancer","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/3/08/550","url":"https://www.ema.europa.eu/en/medicines/human/orphan-designations/eu-3-08-550","date":"2026-11-11T09:12:26Z"},"context":[]},{"id":"eu_authorised","label":"Authorised in the EU","value":"no","detail":"Theraloc: application withdrawn, orphan medicine","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 EPAR Theraloc","url":"https://www.ema.europa.eu/en/medicines/human/EPAR/theraloc","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":"no","detail":"FDA's table lists no pediatric approval of Nimotuzumab","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":"2026-11-11T15:23:02.341Z"},"context":[]},{"id":"studies_under_18","label":"Registered studies open to children","value":"yes","detail":"7 interventional studies of Nimotuzumab include patients under 18; 0 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=%22Nimotuzumab%22&aggFilters=ages%3Achild%2CstudyType%3Aint","date":"2026-11-11T15:23:02.347Z"},"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":"Cited case","text":"In February 2022 FDA asked its Oncologic Drugs Advisory Committee whether sintilimab's application, resting on ORIENT-11, a phase 3 run only in China, needed further trials showing it applies to US patients and US practice. One case, not a rule.","source":{"label":"FDA, ODAC 10 Feb 2022, draft questions","url":"https://www.fda.gov/media/156017/download","date":"2022-02-10"}},{"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":"Eurofarma Laboratorios S.A. (industry)","source":{"label":"ClinicalTrials.gov NCT01345084","url":"https://clinicaltrials.gov/study/NCT01345084","date":"2026-11-11T15:23:02.326Z"}},{"label":"principal investigator","text":"Gustavo Girotto, Hospital de Base","source":{"label":"Person page","url":"/person/Gustavo%20Girotto","date":"2026-11-11T15:23:02.326Z"}}],"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 NCT01345084","url":"https://clinicaltrials.gov/study/NCT01345084","date":"2026-11-11T15:23:02.326Z"},{"label":"Open Targets Platform","url":"https://platform.opentargets.org","date":"2026-11-11T15:23:02.326Z"},{"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":"2026-11-11T15:23:02.322Z"}