{"ok":true,"data":{"subject":{"kind":"trial","nctId":"NCT00652899","title":"Allogeneic Natural Killer Cells in Patients With Recurrent Ovarian Cancer, Fallopian Tube, and Primary Peritoneal Cancer","sponsor":"Masonic Cancer Center, University of Minnesota","phases":["PHASE2"],"status":"TERMINATED","indication":null,"disease":"fallopian tube cancer"},"rows":[{"n":1,"question":"Is the biology right?","flags":[{"id":"somatic_driver","label":"Somatic driver evidence","value":"no","detail":"None of XDH, RRM1, RRM2B, RRM2, IL2RA, IL2RG, IL2RB has somatic-mutation evidence in fallopian tube cancer","rule":"Open Targets has somatic-mutation evidence for the target in this cancer","source":{"label":"Open Targets: XDH in fallopian tube cancer","url":"https://platform.opentargets.org/evidence/ENSG00000158125/MONDO_0002158","date":"2026-11-12T06:33:08.318Z"},"context":[]},{"id":"human_genetic","label":"Human genetic evidence","value":"no","detail":"No germline or somatic evidence for XDH, RRM1, RRM2B, RRM2, IL2RA, IL2RG, IL2RB in fallopian tube cancer","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: XDH in fallopian tube cancer","url":"https://platform.opentargets.org/evidence/ENSG00000158125/MONDO_0002158","date":"2026-11-12T06:33:08.318Z"},"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 NCT00652899","url":"https://clinicaltrials.gov/study/NCT00652899","date":"2026-11-12T06:33:08.318Z"},"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":"Cyclophosphamide: standard agents, not counted in these flags."},{"label":"XDH (via Allopurinol)","text":"Open Targets has no association between XDH and fallopian tube cancer.","source":{"label":"Open Targets: XDH in fallopian tube cancer","url":"https://platform.opentargets.org/evidence/ENSG00000158125/MONDO_0002158","date":"2026-11-12T06:33:08.318Z"}},{"label":"RRM1 (via Fludarabine phosphate)","text":"Evidence types in fallopian tube cancer: clinical. Datasources: clinical_precedence.","source":{"label":"Open Targets: RRM1 in fallopian tube cancer","url":"https://platform.opentargets.org/evidence/ENSG00000167325/MONDO_0002158","date":"2026-11-12T06:33:08.318Z"}},{"label":"RRM2B (via Fludarabine phosphate)","text":"Evidence types in fallopian tube cancer: clinical. Datasources: clinical_precedence.","source":{"label":"Open Targets: RRM2B in fallopian tube cancer","url":"https://platform.opentargets.org/evidence/ENSG00000048392/MONDO_0002158","date":"2026-11-12T06:33:08.318Z"}},{"label":"RRM2 (via Fludarabine phosphate)","text":"Evidence types in fallopian tube cancer: clinical. Datasources: clinical_precedence.","source":{"label":"Open Targets: RRM2 in fallopian tube cancer","url":"https://platform.opentargets.org/evidence/ENSG00000171848/MONDO_0002158","date":"2026-11-12T06:33:08.318Z"}},{"label":"IL2RA (via Aldesleukin)","text":"Evidence types in fallopian tube cancer: clinical. Datasources: clinical_precedence.","source":{"label":"Open Targets: IL2RA in fallopian tube cancer","url":"https://platform.opentargets.org/evidence/ENSG00000134460/MONDO_0002158","date":"2026-11-12T06:33:08.318Z"}},{"label":"IL2RG (via Aldesleukin)","text":"Evidence types in fallopian tube cancer: clinical. Datasources: clinical_precedence.","source":{"label":"Open Targets: IL2RG in fallopian tube cancer","url":"https://platform.opentargets.org/evidence/ENSG00000147168/MONDO_0002158","date":"2026-11-12T06:33:08.318Z"}},{"label":"IL2RB (via Aldesleukin)","text":"Evidence types in fallopian tube cancer: clinical. Datasources: clinical_precedence.","source":{"label":"Open Targets: IL2RB in fallopian tube cancer","url":"https://platform.opentargets.org/evidence/ENSG00000100385/MONDO_0002158","date":"2026-11-12T06:33:08.318Z"}}],"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 NCT00652899","url":"https://clinicaltrials.gov/study/NCT00652899","date":"2026-11-12T06:33:08.318Z"},"context":[]},{"id":"small_denominator","label":"Small denominator","value":"yes","detail":"14 enrolled; each patient moves a rate by 100 ÷ 14 = 7.1 points","rule":"Enrolment under 30; the arithmetic is shown, not a benchmark","source":{"label":"ClinicalTrials.gov NCT00652899","url":"https://clinicaltrials.gov/study/NCT00652899","date":"2026-11-12T06:33:08.318Z"},"context":[]},{"id":"primary_os","label":"Primary endpoint is overall survival","value":"no","detail":"Number of Patients With In Vivo Expansion of Infused Allogeneic Natural Killer (NK) Cell Product","rule":"A registered primary outcome measure names overall survival","source":{"label":"ClinicalTrials.gov NCT00652899","url":"https://clinicaltrials.gov/study/NCT00652899","date":"2026-11-12T06:33:08.318Z"},"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":"no","detail":"Results posted 2010-09-15","rule":"Primary completion (actual) more than 12 months ago and no results posted to the registry","source":{"label":"ClinicalTrials.gov NCT00652899","url":"https://clinicaltrials.gov/study/NCT00652899?tab=results","date":"2026-11-12T06:33:08.318Z"},"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":"29 terminated, withdrawn or suspended trials of drugs against XDH; 4 give no reason. Reasons are quoted as the registry gives them on the target page.","source":{"label":"XDH: what already stopped","url":"/target/ENSG00000158125#stopped","date":"2026-11-12T06:33:08.335Z"}}],"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":"The only site is in United States","rule":"All listed sites are in one country; the share of US sites is shown","source":{"label":"ClinicalTrials.gov NCT00652899","url":"https://clinicaltrials.gov/study/NCT00652899?tab=locations","date":"2026-11-12T06:33:08.318Z"},"context":[]},{"id":"eu_pip","label":"EU paediatric investigation plan","value":"yes","detail":"EMEA-001556-PIP02-24 (aldesleukin, Treatment of amyotrophic lateral sclerosis): W: decision granting a waiver in all age groups for all conditions or indications, 13 Sept 2024; EMEA-002754-PIP01-19 (allopurinol;verinurad, Treatment of chronic kidney disease): P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), 29 Jan 2021; EMEA-001952-PIP01-16 (lesinurad;allopurinol, Treatment of hyperuricaemia): W: decision granting a waiver in all age groups for all conditions or indications, 9 Sept 2016","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/3/25/3041 positive 25 Mar 2025: Treatment of Marfan syndrome; EU/3/22/2578 positive 24 Feb 2022: Treatment of amyotrophic lateral sclerosis; EU/3/12/1076 positive 6 Dec 2012: Treatment of perinatal asphyxia; EU/3/15/1493 positive 21 May 2015: Treatment of perinatal asphyxia; +1 more","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 data download (dated snapshot)","url":"https://www.ema.europa.eu/en/documents/report/medicines-output-orphan_designations-json-report_en.json","date":"2026-11-11T09:12:26Z"},"context":[]},{"id":"eu_authorised","label":"Authorised in the EU","value":"no","detail":"Duzallo: withdrawn since 23 Aug 2018","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 Duzallo","url":"https://www.ema.europa.eu/en/medicines/human/EPAR/duzallo","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 Allopurinol, Fludarabine phosphate, Allogeneic natural killer cells, Aldesleukin","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":"2026-11-12T06:33:08.342Z"},"context":[]},{"id":"studies_under_18","label":"Registered studies open to children","value":"yes","detail":"1019 interventional studies of Allopurinol, Fludarabine phosphate, Allogeneic natural killer cells, Aldesleukin include patients under 18; 266 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=%22Allopurinol%22+OR+%22Fludarabine+phosphate%22+OR+%22Allogeneic+natural+killer+cells%22+OR+%22Aldesleukin%22&aggFilters=ages%3Achild%2CstudyType%3Aint","date":"2026-11-12T06:33:08.343Z"},"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":"Masonic Cancer Center, University of Minnesota (academic or other)","source":{"label":"ClinicalTrials.gov NCT00652899","url":"https://clinicaltrials.gov/study/NCT00652899","date":"2026-11-12T06:33:08.318Z"}},{"label":"principal investigator","text":"Melissa A. Geller, MD, Masonic Cancer Center, University of Minnesota","source":{"label":"Person page","url":"/person/Melissa%20A.%20Geller%2C%20MD","date":"2026-11-12T06:33:08.318Z"}}],"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 NCT00652899","url":"https://clinicaltrials.gov/study/NCT00652899","date":"2026-11-12T06:33:08.318Z"},{"label":"Open Targets Platform","url":"https://platform.opentargets.org","date":"2026-11-12T06:33:08.318Z"},{"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":"2026-11-12T06:33:08.317Z"}