{"entity":{"id":"nct03706365","kind":"trial","name":"A Study of Abiraterone Acetate Plus Prednisone With or Without Abemaciclib (LY2835219) in Participants With Prostate Cancer","aka":["CYCLONE 2"],"tldr":"A phase 2/3 trial of Abemaciclib, Abiraterone acetate, Prednisone in prostate cancer, run by Eli Lilly and Company, active and no longer recruiting.","summary":"A Study of Abiraterone Acetate Plus Prednisone With or Without Abemaciclib (LY2835219) in Participants With Prostate Cancer is a phase 2/3 interventional study registered as NCT03706365 by Eli Lilly and Company, with 393 participants enrolled, started 2018-11-26 and due to reach its primary completion in 2024-01-02. Interventions recorded: Abemaciclib, Placebo, Abiraterone acetate, Prednisone. Conditions listed: Prostate Cancer. Results were posted on ClinicalTrials.gov in 2025; the figures recorded here are the registry's, not a publication's.","status":"active","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT03706365","url":"https://clinicaltrials.gov/study/NCT03706365"}],"tags":["ctgov-ingest"],"related":[],"cancers":["prostate","prostate-mcrpc"],"sections":[],"technologies":["androgen-deprivation","cdk46-inhibitor"],"targets":[],"drugs":["abemaciclib","abiraterone","prednisone"],"companies":["eli-lilly"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-nct03706365-lancet-oncol-2025"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03706365","phase":"2/3","setting":"A Phase 2/3, Randomized, Double-Blind, Placebo-Controlled Study of Abiraterone Acetate Plus Prednisone With or Without Abemaciclib in Patients With Metastatic Castration-Resistant Prostate Cancer","sponsor":"Eli Lilly and Company","started":"2018-11-26","startedType":"actual","yearReported":2025,"enrolled":393,"enrolledBasis":"registry","outcomes":[{"endpoint":"Radiographic Progression Free Survival (rPFS)","primary":true,"unit":"months","arms":[{"name":"Abemaciclib","n":206,"value":21.96,"note":"95% CI 19.33 to 27.48; Figures from the ClinicalTrials.gov results section (first posted 2025-03-06), not from a publication"},{"name":"Placebo","n":187,"value":20.28,"note":"95% CI 16.47 to 24.36"}],"hr":0.829,"ci":[0.619,1.111],"p":"0.2123","source":"https://clinicaltrials.gov/study/NCT03706365?tab=results"},{"endpoint":"Overall Survival (OS)","unit":"months","arms":[{"name":"Abemaciclib","n":206,"value":38.01,"note":"95% CI 30.58 to 46.65; Figures from the ClinicalTrials.gov results section (first posted 2025-03-06), not from a publication"},{"name":"Placebo","n":187,"value":33.21,"note":"95% CI 29.52 to NA"}],"hr":0.927,"ci":[0.669,1.285],"p":"0.6507","source":"https://clinicaltrials.gov/study/NCT03706365?tab=results"},{"endpoint":"Objective Response Rate (ORR): Percentage of Participants With a Complete Response (CR) or Partial Response (PR)","unit":"%","arms":[{"name":"Abemaciclib","n":84,"value":45.2,"note":"95% CI 34.6 to 55.9; Figures from the ClinicalTrials.gov results section (first posted 2025-03-06), not from a publication"},{"name":"Placebo","n":73,"value":54.8,"note":"95% CI 43.4 to 66.2"}],"source":"https://clinicaltrials.gov/study/NCT03706365?tab=results"}]},"route":"/trials/nct03706365/","neighbours":{"cancer":[{"id":"prostate-mcrpc","kind":"cancer","name":"Metastatic castration-resistant prostate cancer","route":"/cancers/prostate-mcrpc/"},{"id":"prostate","kind":"cancer","name":"Prostate cancer","route":"/cancers/prostate/"}],"technology":[{"id":"androgen-deprivation","kind":"technology","name":"Androgen deprivation & AR pathway inhibitors","route":"/technologies/androgen-deprivation/"},{"id":"cdk46-inhibitor","kind":"technology","name":"CDK4/6 inhibitors","route":"/technologies/cdk46-inhibitor/"}],"drug":[{"id":"abemaciclib","kind":"drug","name":"Abemaciclib","route":"/drugs/abemaciclib/"},{"id":"abiraterone","kind":"drug","name":"Abiraterone acetate","route":"/drugs/abiraterone/"},{"id":"prednisone","kind":"drug","name":"Prednisone","route":"/drugs/prednisone/"}],"company":[{"id":"eli-lilly","kind":"company","name":"Eli Lilly (incl. Loxo)","route":"/companies/eli-lilly/"}],"paper":[{"id":"paper-nct03706365-lancet-oncol-2025","kind":"paper","name":"Abemaciclib plus abiraterone in patients with metastatic castration-resistant prostate cancer (CYCLONE 2): a randomised, double-blind, placebo-controlled, phase 3 trial","route":"/key-papers/paper-nct03706365-lancet-oncol-2025/"}]}}