{"preliminary_commentary":{"by_channel":{"x_thread":3},"note":"Preliminary. Indexed podcasts, YouTube videos and X posts that name this trial so far. This is where a report starts, not where it ends: the build searches for more, so finished reports usually cover more than this."},"free_build":{"available":false},"commentary_summary":null,"drugs_tested":[["Debio 1347"]],"indication":"advanced solid tumors with FGFR alterations","name":"NCT01948297","nct_id":"NCT01948297","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=nct01948297. The price is an estimate of verified statements from the commentary indexed so far. Final coverage is set when the report is built. You never pay more than quoted: if the report is delivered at a smaller size, you pay that size's price, and anything paid above it is refunded. We build the report within 24 hours of confirming the order and deliver it when it passes our checks; if it cannot be built to our standard, nothing is charged.","price_rule":"Never more than quoted: the buyer pays the smaller of price_usd and the price the delivered edition is sold at.","price_usd":750,"size":"focused","size_rule":"Focused: 1–150 verified statements, estimated at 14 per indexed commentary source"},"registry":{"acronym":null,"arms":[{"description":"Adaptive doses of Debio1347 (CH5183284) - (10 mg to 210 mg/day) until the recommended dose (RD) is determined.","label":"Part A","type":"EXPERIMENTAL"},{"description":"Participants with various tumours receive Debio1347 (CH5183284) orally at the recommended dose established during Part A.","label":"Part B","type":"EXPERIMENTAL"}],"collaborators":[],"completion_date":{"date":"2020-06-26","type":"ACTUAL"},"conditions":["Solid Tumours"],"enrollment":{"count":77,"type":"ACTUAL"},"has_results":false,"interventions":[{"name":"Debio1347 (CH5183284)","otherNames":["CH5183284"],"type":"DRUG"}],"last_update":"2020-09-09","lead_sponsor":"Debiopharm International SA","official_title":"A Phase I, Gene Alteration-based, Open Label, Multicenter Study of Oral Debio 1347 (CH5183284) in Patients With Advanced Solid Malignancies, Whose Tumours Have an Alteration of the FGFR 1, 2 or 3 Genes","overall_status":"TERMINATED","phases":["PHASE1"],"primary_completion_date":{"date":"2020-06-26","type":"ACTUAL"},"primary_outcomes":[{"measure":"Part A: Percentage of Participants With Dose-Limiting Toxicities (DLTs) From Debio 1347","timeFrame":"within approximately 18 months"},{"measure":"Part B: Percentage of Participants With Treatment-Emergent Serious Adverse Events (SAEs)","timeFrame":"within 2 years of starting treatment"},{"measure":"Part B: Number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment","timeFrame":"within 2 years of starting treatment"},{"measure":"Part B: Severity of Treatment-Emergent AEs","timeFrame":"within 2 years of starting treatment"},{"measure":"Part B: Severity of Laboratory Abnormalities","timeFrame":"within 2 years of starting treatment"}],"references":[],"start_date":{"date":"2013-08"},"study_type":"INTERVENTIONAL","title":"Debio 1347-101 Phase I Trial in Advanced Solid Tumours With Fibroblast Growth Factor Receptor (FGFR) Alterations","url":"https://clinicaltrials.gov/study/NCT01948297"},"report":null,"schema_id":"erudio.trial_listing","schema_version":"3.2","state":"listed","state_text":"No report yet. It can be ordered.","url":"https://www.erudio.com/trials/nct01948297"}