{"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":null,"indication":null,"name":"NCT04113616","nct_id":"NCT04113616","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=nct04113616. The price is an estimate of verified statements from the commentary indexed so far, fixed at order. Final coverage is set when the report is built. 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_usd":750,"size":"focused","size_rule":"Focused: 1–150 verified statements, estimated at 14 per indexed commentary source"},"registry":{"acronym":null,"arms":[{"description":"KRT-232+LDAC:\n\nKRT-232 will be administered orally, once daily (QD), on Days 1-7 in combination with LDAC administered at 20 mg/m2/day subcutaneously on Days 1-10 in a 28-day cycle.","label":"Part A - Arm 1","type":"EXPERIMENTAL"},{"description":"KRT-232(7-Day)+Decitabine:\n\nKRT-232 will be administered orally, once daily (QD), on Days 1-7 in combination with Decitabine administered at 20 mg/m2/day intravenously on Days 1-5 in a 28-day cycle.","label":"Part A - Arm 2","type":"EXPERIMENTAL"},{"description":"KRT-232(14-Day)+Decitabine:\n\nKRT-232 will be administered orally, once daily (QD), on Days 1-7 and Days 15-21 (7 days on/7 days off/7 days on/7 days off) in combination with Decitabine administered at 20 mg/m2/day intravenously on Days 1-5 in a 28-day cycle.","label":"Part A - Arm 3","type":"EXPERIMENTAL"},{"description":"KRT-232 administered at 360 mg orally, once daily (QD) on Days 1-7 with 21 days off on a 28-day treatment cycle","label":"Part B - Arm 1","type":"EXPERIMENTAL"},{"description":"KRT-232 administered at 360 mg orally, once daily (QD) on Days 1-7 with 21 days off on a 28-day treatment cycle in Cycle 1, followed by 240 mg orally, once daily (QD) on Days 1-7 with 21 days off on a 28-day cycle, in the subsequent cycles.","label":"Part B - Arm 2","type":"EXPERIMENTAL"},{"description":"KRT-232 administered at 180 mg orally, once daily (QD) on Days 1-7 with 14 days off on a 21-day treatment cycle.","label":"Part B - Arm 3","type":"EXPERIMENTAL"}],"collaborators":[],"completion_date":{"date":"2023-09-27","type":"ACTUAL"},"conditions":["Relapsed or Refractory Acute Myeloid Leukemia (AML)","Acute Myeloid Leukemia (AML), Secondary to Myeloproliferative Neoplasms (MPN)"],"enrollment":{"count":70,"type":"ACTUAL"},"has_results":false,"interventions":[{"name":"KRT-232","otherNames":[],"type":"DRUG"},{"name":"Cytarabine","otherNames":["cytosine arabinoside","Cytosar-U","Depocyt","Arabinosylcytosine","Ara-C"],"type":"DRUG"},{"name":"Decitabine","otherNames":["Dacogen"],"type":"DRUG"}],"last_update":"2024-03-22","lead_sponsor":"Kartos Therapeutics, Inc.","official_title":"An Open-Label, Multicenter, Phase 1b/2 Study of the Safety and Efficacy of KRT-232 When Administered Alone and in Combination With Low-Dose Cytarabine (LDAC) or Decitabine in Patients With Acute Myeloid Leukemia (AML)","overall_status":"TERMINATED","phases":["PHASE1","PHASE2"],"primary_completion_date":{"date":"2023-09-27","type":"ACTUAL"},"primary_outcomes":[{"measure":"Part A: To determine KRT-232 recommended phase 2 dose (RP2D)","timeFrame":"28 Days"},{"measure":"Part B: To determine the RP2D of KRT-232","timeFrame":"2 years after last patient enrolled"}],"references":[],"start_date":{"date":"2019-09-25","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"An Open-Label, Multicenter, Phase 1b/2 Study of the Safety and Efficacy of KRT-232 When Administered Alone and in Combination With Low-Dose Cytarabine (LDAC) or Decitabine in Patients With Acute Myeloid Leukemia (AML)","url":"https://clinicaltrials.gov/study/NCT04113616"},"report":null,"schema_id":"erudio.trial_listing","schema_version":"3.1","state":"listed","state_text":"No report yet. It can be ordered.","url":"https://www.erudio.com/trials/nct04113616"}