{"ok":true,"data":{"subject":{"kind":"trial","nctId":"NCT00540839","title":"A Study of Montelukast (MK-0476) Compared With Fluticasone in Pediatric Participants With Chronic Asthma (MK-0476-303)","sponsor":"Organon and Co","phases":["PHASE3"],"status":"WITHDRAWN","indication":null,"disease":"atopic IgE-mediated allergic disorder"},"rows":[{"n":1,"question":"Is the biology right?","flags":[{"id":"somatic_driver","label":"Somatic driver evidence","value":"no","detail":"None of CYSLTR1, NR3C1 has somatic-mutation evidence in atopic IgE-mediated allergic disorder","rule":"Open Targets has somatic-mutation evidence for the target in this cancer","source":{"label":"Open Targets: CYSLTR1 in atopic IgE-mediated allergic disorder","url":"https://platform.opentargets.org/evidence/ENSG00000173198/MONDO_0005202","date":"2026-11-12T09:13:43.350Z"},"context":[]},{"id":"human_genetic","label":"Human genetic evidence","value":"no","detail":"No germline or somatic evidence for CYSLTR1, NR3C1 in atopic IgE-mediated allergic disorder","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: CYSLTR1 in atopic IgE-mediated allergic disorder","url":"https://platform.opentargets.org/evidence/ENSG00000173198/MONDO_0005202","date":"2026-11-12T09:13:43.350Z"},"context":[]},{"id":"pediatric_target","label":"Pediatric target","value":"no","detail":"Not 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 NCT00540839","url":"https://clinicaltrials.gov/study/NCT00540839","date":"2026-11-12T09:13:43.350Z"},"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":"CYSLTR1 (via Montelukast sodium)","text":"Evidence types in atopic IgE-mediated allergic disorder: clinical. Datasources: clinical_precedence.","source":{"label":"Open Targets: CYSLTR1 in atopic IgE-mediated allergic disorder","url":"https://platform.opentargets.org/evidence/ENSG00000173198/MONDO_0005202","date":"2026-11-12T09:13:43.350Z"}},{"label":"NR3C1 (via Fluticasone propionate)","text":"Open Targets has no association between NR3C1 and atopic IgE-mediated allergic disorder.","source":{"label":"Open Targets: NR3C1 in atopic IgE-mediated allergic disorder","url":"https://platform.opentargets.org/evidence/ENSG00000113580/MONDO_0005202","date":"2026-11-12T09:13:43.350Z"}}],"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 NCT00540839","url":"https://clinicaltrials.gov/study/NCT00540839","date":"2026-11-12T09:13:43.350Z"},"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 NCT00540839","url":"https://clinicaltrials.gov/study/NCT00540839","date":"2026-11-12T09:13:43.350Z"},"context":[]},{"id":"primary_os","label":"Primary endpoint is overall survival","value":"no","detail":"Percentage of days without asthma; Number of participants who experience at least one adverse event (AE); Number of participants who discontinue study drug due to an AE","rule":"A registered primary outcome measure names overall survival","source":{"label":"ClinicalTrials.gov NCT00540839","url":"https://clinicaltrials.gov/study/NCT00540839","date":"2026-11-12T09:13:43.350Z"},"context":[{"figure":"Non-OS primary endpoint: odds ratio 2.79 for a positive phase 3","dataset":"Otsuka 2021, 400 phase 3 oncology trials","years":"to 2020","caveat":"Shown with the next figure: a surrogate is easier to hit, and often a weak guide to survival."},{"figure":"52% of surrogate-to-OS correlations are low","dataset":"Prasad 2015","years":"published to 2014","caveat":"Shown with the figure above."}]},{"id":"results_overdue","label":"Results overdue","value":"yes","detail":"Primary completion 2008-03, 224 months ago; no results posted","rule":"Primary completion (actual) more than 12 months ago and no results posted to the registry","source":{"label":"ClinicalTrials.gov NCT00540839","url":"https://clinicaltrials.gov/study/NCT00540839","date":"2026-11-12T09:13:43.350Z"},"context":[{"figure":"40.9% of applicable trials report results within a year","dataset":"Results-reporting studies summarised in spec §11","years":"all therapy areas","caveat":"All areas, not oncology only."}]}],"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":"29 terminated, withdrawn or suspended trials of drugs against CYSLTR1; 6 give no reason. Reasons are quoted as the registry gives them on the target page.","source":{"label":"CYSLTR1: what already stopped","url":"/target/ENSG00000173198#stopped","date":"2026-11-12T09:13:43.353Z"}}],"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":"not published","detail":"The record lists no sites.","rule":"All listed sites are in one country; the share of US sites is shown","source":{"label":"ClinicalTrials.gov NCT00540839","url":"https://clinicaltrials.gov/study/NCT00540839?tab=locations","date":"2026-11-12T09:13:43.350Z"},"context":[]},{"id":"eu_pip","label":"EU paediatric investigation plan","value":"yes","detail":"EMEA-003629-PIP01-24 (montelukast sodium;rupatadine fumarate, Treatment of allergic rhinitis): RW: decision refers to a refusal on a request for waiver in all age groups for the listed condition(s), 13 Sept 2024; EMEA-002646-PIP01-19 (levocetirizine;montelukast, Treatment of allergic rhinitis): W: decision granting a waiver in all age groups for all conditions or indications, 10 Feb 2020; EMEA-002140-PIP01-17 (fluticasone propionate, Treatment of asthma): W: decision granting a waiver in all age groups for all conditions or indications, 4 Sept 2017; EMEA-002177-PIP01-17 (fluticasone propionate;salmeterol xinafoate, Treatment of asthma): W: decision granting a waiver in all age groups for all conditions or indications, 4 Sept 2017; +4 more","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/3/16/1815 positive 12 Jan 2017: Treatment of eosinophilic oesophagitis","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/3/16/1815","url":"https://www.ema.europa.eu/en/medicines/human/orphan-designations/eu-3-16-1815","date":"2026-11-11T09:12:26Z"},"context":[]},{"id":"eu_authorised","label":"Authorised in the EU","value":"yes","detail":"Seffalair Spiromax: authorised since 26 Mar 2021; BroPair Spiromax: withdrawn since 26 Mar 2021; Aerivio Spiromax: withdrawn since 18 Aug 2016; Airexar Spiromax: withdrawn since 18 Aug 2016","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":"no","detail":"FDA's table lists no pediatric approval of Montelukast sodium, Fluticasone propionate","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":"2026-11-12T09:13:43.361Z"},"context":[]},{"id":"studies_under_18","label":"Registered studies open to children","value":"yes","detail":"343 interventional studies of Montelukast sodium, Fluticasone propionate include patients under 18; 17 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=%22Montelukast+sodium%22+OR+%22Fluticasone+propionate%22&aggFilters=ages%3Achild%2CstudyType%3Aint","date":"2026-11-12T09:13:43.361Z"},"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":"Organon and Co (industry)","source":{"label":"ClinicalTrials.gov NCT00540839","url":"https://clinicaltrials.gov/study/NCT00540839","date":"2026-11-12T09:13:43.350Z"}},{"label":"study director","text":"Medical Director, Merck Sharp & Dohme LLC","source":{"label":"Person page","url":"/person/Medical%20Director","date":"2026-11-12T09:13:43.350Z"}}],"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 NCT00540839","url":"https://clinicaltrials.gov/study/NCT00540839","date":"2026-11-12T09:13:43.350Z"},{"label":"Open Targets Platform","url":"https://platform.opentargets.org","date":"2026-11-12T09:13:43.350Z"},{"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":"2026-11-12T09:13:43.349Z"}