Clinical trial · Interventional
A Study of Abiraterone Acetate Plus Prednisone With or Without Abemaciclib (LY2835219) in Participants With Prostate Cancer
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
NCT03706365CI-TRIAL-00121010CYCLONE 2active not recruitingPhase 2 / Phase 3Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study is being done to see how safe and effective abemaciclib is when given together with abiraterone acetate plus prednisone in participants with metastatic castration resistant prostate cancer. Prednisolone may be used instead of prednisone per local regulation.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Abemaciclib | Drug | Abemaciclib | ALIAS |
| Abiraterone acetate | Drug | Abiraterone Acetate | ALIAS |
| Placebo | Drug | — | UNRESOLVED |
| Prednisone | Drug | Prednisone | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Abemaciclib
- description
- Participants received 200 milligrams (mg) abemaciclib twice daily (BID) in combination with standard doses of 1000 mg abiraterone acetate once daily and 5 mg prednisone BID administered orally on a continuous dosing schedule on days 1 through 28 of a 28-day cycle until radiographic and/or symptomatic progression or until another discontinuation criterion is met.
- interventionNames
- Drug: Abemaciclib
- Drug: Abiraterone acetate
- Drug: Prednisone
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- Participants received placebo BID in combination with standard doses of 1000 mg abiraterone acetate once daily and 5 mg prednisone BID administered orally on a continuous dosing schedule on days 1 through 28 of a 28-day cycle until radiographic and/or symptomatic progression or until another discontinuation criterion is met.
- interventionNames
- Drug: Placebo
- Drug: Abiraterone acetate
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed adenocarcinoma of the prostate. * Metastatic prostate cancer documented by positive bone scan and/or measurable soft tissue metastatic lesions by CT or magnetic resonance imaging (MRI). * Progressive disease at study entry demonstrated during continuous androgen-deprivation therapy (ADT)/post orchiectomy defined as one or more of the following: * PSA progression * Radiographic progression per Response Evaluation Criteria in Solid Tumors (RECIST)1.1 for soft tissue and/or per Prostate Cancer Working Group 3 (PCWG3) for bone, with or without PSA progression * Have adequate organ function. * Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1. Exclusion Criteria: * Prior therapy with cytochrome P450 (CYP)17 inhibitors. * Prior treatment with abemaciclib or any cyclin-dependent kinase (CDK) 4 \& 6 inhibitors. * Prior cytotoxic chemotherapy for metastatic castration resistant prostate cancer (participants treated with docetaxel in the metastatic hormone-sensitive prostate cancer \[mHSPC\] are eligible). Prior radiopharmaceuticals for prostate cancer, or prior enzalutamide, apalutamide, darolutamide or sipuleucel-T. Participants who had prior radiation or surgery to all target lesions. * Currently enrolled in a clinical study involving an investigational product. * Gastrointestinal disorder affecting the absorption or ability to swallow large pills. * Clinically significant heart disease, active or chronic liver disease, moderate/severe hepatic impairment (Child-Pugh Class B and C).
References
Publications (1)
- DERIVEDSmith M, Piulats J, Todenhofer T, Lee JL, Arija JA, Mazilu L, Azad A, Alonso-Gordoa T, McGovern U, Choudhury A, Horvath L, Ye D, Han W, Suzuki H, Uemura H, McKay R, Ades S, Flechon A, Pieczonka C, Fernandes MS, Hulstijn M, Lithio A, Nacerddine K, Agarwal N; CYCLONE 2 investigators. Abemaciclib plus abiraterone in patients with metastatic castration-resistant prostate cancer (CYCLONE 2): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Oncol. 2025 Nov;26(11):1489-1500. doi: 10.1016/S1470-2045(25)00475-9. PMID 41167216