{"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":[["abemaciclib","sunitinib"]],"indication":"metastatic renal cell carcinoma","name":"PICKRCC","nct_id":"NCT03905889","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=pickrcc-nct03905889. 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":"For the dose escalation phase, Subjects will receive a 21-day cycle of continuous oral daily Sunitinib in combination with Abemaciclib every 12 hours for 14 days followed by 7 days off. Using a traditional 3 x 3 study design assessing dose limiting toxicity, if the initial prescribed dosing of these 2 medications (Dose Level 1) is tolerated by the first 3 subjects, the study will pause for a 30 day time period between cohorts to assess toxicity. If no dose limiting toxicity is identified, the next cohort of 3 new subjects will be treated at the next higher dose level (Dose Level 2). If the original cohort treated at Dose Level 1 do not tolerate the combination of medications, the medication regimen will be modified to a lower dose (Dose Level - 1). A dose expansion phase is included which will evaluate the combination of Abemaciclib in combination with Sunitinib when given at the maximum tolerated dose as determined from the from dose escalation phase.","label":"Experimental Abemaciclib and Sunitinib","type":"EXPERIMENTAL"}],"collaborators":["Eli Lilly and Company"],"completion_date":{"date":"2022-03-08","type":"ACTUAL"},"conditions":["Renal Cell Carcinoma Metastatic"],"enrollment":{"count":3,"type":"ACTUAL"},"has_results":false,"interventions":[{"name":"Abemaciclib","otherNames":["Verzenio"],"type":"DRUG"},{"name":"Sunitinib","otherNames":["Sutent"],"type":"DRUG"}],"last_update":"2024-06-25","lead_sponsor":"Brown University","official_title":"Targeting PIM1 and CDK4/6 Kinases in Renal Cell Carcinoma (PICKRCC): A Phase Ib Study of Abemaciclib (VerzenioTM) in Combination With Sunitinib in Metastatic Renal Cell Carcinoma","overall_status":"TERMINATED","phases":["PHASE1"],"primary_completion_date":{"date":"2022-03-08","type":"ACTUAL"},"primary_outcomes":[{"measure":"Maximum tolerated dose (MTD)","timeFrame":"At the end of Cycle 1 (each cycle is 21 days)"},{"measure":"Continued Toxicity assessment of the maximum tolerated dose (i.e the recommended Phase II dose) of Abemaciclib and Sunitinib as determined from the from dose escalation phase.","timeFrame":"44 days after the last dose of study drug"},{"measure":"Pharmacokinetic Assessment of Abemaciclib and Sunitinib trough levels at steady state","timeFrame":"Days 8, 15, 21, 28, 35, 42, 56, 63, 77, 84, 98 (at the beginning and weekly during cycles 1 and 2, days 1 and 15 of cycles 3-5; a cycle is 21-days)"}],"references":[],"start_date":{"date":"2019-06-05","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"A Study of Abemaciclib in Combination With Sunitinib in Metastatic Renal Cell Carcinoma","url":"https://clinicaltrials.gov/study/NCT03905889"},"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/pickrcc-nct03905889"}