{"ok":true,"data":{"subject":{"kind":"trial","nctId":"NCT02516423","title":"Ixazomib Citrate, Lenalidomide, Dexamethasone, and Zoledronic Acid or Zoledronic Acid Alone After Radiation Therapy in Treating Patients With Solitary Plasmacytoma of Bone","sponsor":"Alliance for Clinical Trials in Oncology","phases":["PHASE3"],"status":"TERMINATED","indication":null,"disease":null},"rows":[{"n":1,"question":"Is the biology right?","flags":[{"id":"somatic_driver","label":"Somatic driver evidence","value":"not published","detail":"This trial's cancer could not be matched to an Open Targets disease.","rule":"Open Targets has somatic-mutation evidence for the target in this cancer","source":{"label":"Open Targets Platform","url":"https://platform.opentargets.org","date":"2026-11-11T19:00:20.952Z"},"context":[]},{"id":"human_genetic","label":"Human genetic evidence","value":"not published","detail":"This trial's cancer could not be matched to an Open Targets disease.","rule":"Any germline or somatic human genetic evidence for the target in this cancer","source":{"label":"Open Targets Platform","url":"https://platform.opentargets.org","date":"2026-11-11T19:00:20.952Z"},"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 NCT02516423","url":"https://clinicaltrials.gov/study/NCT02516423","date":"2026-11-11T19:00:20.952Z"},"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":"lenalidomide: standard agents, not counted in these flags."}],"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 NCT02516423","url":"https://clinicaltrials.gov/study/NCT02516423","date":"2026-11-11T19:00:20.952Z"},"context":[]},{"id":"small_denominator","label":"Small denominator","value":"yes","detail":"11 enrolled; each patient moves a rate by 100 ÷ 11 = 9.1 points","rule":"Enrolment under 30; the arithmetic is shown, not a benchmark","source":{"label":"ClinicalTrials.gov NCT02516423","url":"https://clinicaltrials.gov/study/NCT02516423","date":"2026-11-11T19:00:20.952Z"},"context":[]},{"id":"primary_os","label":"Primary endpoint is overall survival","value":"no","detail":"Symptomatic Myeloma Progression Free-survival (PFS) Rate","rule":"A registered primary outcome measure names overall survival","source":{"label":"ClinicalTrials.gov NCT02516423","url":"https://clinicaltrials.gov/study/NCT02516423","date":"2026-11-11T19:00:20.952Z"},"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 2026-06-30","rule":"Primary completion (actual) more than 12 months ago and no results posted to the registry","source":{"label":"ClinicalTrials.gov NCT02516423","url":"https://clinicaltrials.gov/study/NCT02516423?tab=results","date":"2026-11-11T19:00:20.952Z"},"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":"84 terminated, withdrawn or suspended trials of drugs against PSMD1; 7 give no reason. Reasons are quoted as the registry gives them on the target page.","source":{"label":"PSMD1: what already stopped","url":"/target/ENSG00000173692#stopped","date":"2026-11-11T19:00:21.017Z"}}],"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 388 sites in United States","rule":"All listed sites are in one country; the share of US sites is shown","source":{"label":"ClinicalTrials.gov NCT02516423","url":"https://clinicaltrials.gov/study/NCT02516423?tab=locations","date":"2026-11-11T19:00:20.952Z"},"context":[]},{"id":"eu_pip","label":"EU paediatric investigation plan","value":"yes","detail":"EMA/PE/0000225846 (Ixazomib, Treatment of lymphoid malignancies (excluding multiple myeloma);Treatment of Multiple Myeloma): PM: decision on the application for modification of an agreed PIP, 14 Apr 2025; EMEA-000057-PIP01-07-M07 (zoledronic acid, Treatment of osteoporosis;Treatment of Paget’s disease of the bone): PM: decision on the application for modification of an agreed PIP, 17 Jan 2020; compliance positive 30 Apr 2020; EMEA-001410-PIP01-12 (ixazomib citrate, Treatment of systemic light chain amyloidosis): W: decision granting a waiver in all age groups for all conditions or indications, 5 Jul 2013; EMEA-000024-PIP01-07 (zoledronic acid, Osteogenesis imperfecta;Prevention of fracture and bone loss in postmenopausal women with early-stage breast cancer treated with aromatase inhibitors;Prevention of skeletal related events in patients with advanced malignancies involving bone;Tumour-induced hypercalcaemia): P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), 24 Jun 2008; compliance positive 12 Dec 2008","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/3/12/1060 withdrawn 8 Nov 2012: Treatment of systemic light chain amyloidosis; EU/3/11/899 positive 27 Sept 2011: Treatment of multiple myeloma; EU/3/16/1735 positive 29 Aug 2016: Treatment of glioma; EU/3/13/1192 positive 7 Oct 2013: Treatment of complex regional pain syndrome; +2 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":"yes","detail":"Zoledronic acid Mylan: authorised since 23 Aug 2012; Ninlaro: authorised since 21 Nov 2016, orphan medicine; Zoledronic acid Teva: authorised since 16 Aug 2012; Zoledronic acid medac: withdrawn since 3 Aug 2012; +7 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":"no","detail":"FDA's table lists no pediatric approval of ixazomib, zoledronic acid","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":"2026-11-11T19:00:21.036Z"},"context":[]},{"id":"studies_under_18","label":"Registered studies open to children","value":"yes","detail":"56 interventional studies of ixazomib, zoledronic acid include patients under 18; 12 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=%22ixazomib%22+OR+%22zoledronic+acid%22&aggFilters=ages%3Achild%2CstudyType%3Aint","date":"2026-11-11T19:00:21.045Z"},"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":"Alliance for Clinical Trials in Oncology (academic or other)","source":{"label":"ClinicalTrials.gov NCT02516423","url":"https://clinicaltrials.gov/study/NCT02516423","date":"2026-11-11T19:00:20.952Z"}},{"label":"study chair","text":"Anuj Mahindra, MD, Scripps Health","source":{"label":"Person page","url":"/person/Anuj%20Mahindra%2C%20MD","date":"2026-11-11T19:00:20.952Z"}}],"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 NCT02516423","url":"https://clinicaltrials.gov/study/NCT02516423","date":"2026-11-11T19:00:20.952Z"},{"label":"Open Targets Platform","url":"https://platform.opentargets.org","date":"2026-11-11T19:00:20.952Z"},{"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":"2026-11-11T19:00:20.935Z"}