A Study of Abemaciclib (LY2835219) With Abiraterone in Men With Prostate Cancer That Has Spread to Other Parts of the Body and is Expected to Respond to Hormonal Treatment (Metastatic Hormone-Sensitive Prostate Cancer) (CYCLONE 3)
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ClinicalTrials.gov Identifier: NCT05288166 |
Recruitment Status :
Active, not recruiting
First Posted : March 21, 2022
Last Update Posted : April 18, 2024
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Condition or disease | Intervention/treatment | Phase |
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Prostatic Neoplasms Neoplasm Metastasis Urogenital Neoplasms Physiological Effects of Drugs Antineoplastic Agents Antineoplastic Agents, Hormonal Androgens Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Abiraterone Acetate Steroid Synthesis Inhibitors Cytochrome P-450 Enzyme Inhibitors Prednisone Prednisolone Cyclin-Dependent Kinase 4 Cyclin-Dependent Kinase 6 | Drug: Abemaciclib Drug: Abiraterone Drug: Prednisone or Prednisolone Drug: Placebo for Abemaciclib | Phase 3 |
Expanded Access : An investigational treatment associated with this study is available outside the clinical trial. More info ...
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 900 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
Official Title: | CYCLONE 3: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Abemaciclib in Combination With Abiraterone Plus Prednisone in Men With High-Risk Metastatic Hormone-Sensitive Prostate Cancer |
Actual Study Start Date : | April 14, 2022 |
Actual Primary Completion Date : | February 15, 2024 |
Estimated Study Completion Date : | October 2027 |
Arm | Intervention/treatment |
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Experimental: Abemaciclib + Abiraterone + Prednisone/Prednisolone
Abemaciclib plus (+) abiraterone + prednisone/prednisolone administered orally.
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Drug: Abemaciclib
Administered orally.
Other Name: LY2835219 Drug: Abiraterone Administered orally. Drug: Prednisone or Prednisolone Administered orally. |
Active Comparator: Placebo + Abiraterone + Prednisone/Prednisolone
Placebo + abiraterone + prednisone/prednisolone administered orally.
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Drug: Abiraterone
Administered orally. Drug: Prednisone or Prednisolone Administered orally. Drug: Placebo for Abemaciclib Administered orally. |
- Radiographic Progression-Free Survival (rPFS) Assessed by Investigator [ Time Frame: Randomization to radiographic progression or death from any cause (approximately 48 months) ]rPFS Assessed by Investigator
- rPFS Assessed by Blinded Independent Central Review (BICR) [ Time Frame: Randomization to radiographic progression or death from any cause (approximately 48 months) ]rPFS Assessed by BICR
- Castration-resistant Prostate Cancer (CRPC)-free Survival [ Time Frame: Randomization to the earliest date of PSA or radiographic progression with a testosterone level of ≤50 nanogram/deciliter (ng/dL); or death from any cause (approximately 48 months) ]CRPC-free Survival
- Overall Survival (OS) [ Time Frame: Baseline to date of death due to any cause (approximately 60 months) ]OS
- Time to Pain Progression [ Time Frame: Randomization to pain progression (approximately 48 months) ]Measured by a combination of 2 scales, the Brief Pain Inventory Short Form (BPI-SF) Worst Pain Numeric Rating Scale (NRS) and the Analgesic Quantification Algorithm (AQA) scale. The BPI-SF Worst Pain NRS is a self-reported 11-item questionnaire on worst pain intensity on the past 24 hours. Score ranges from 0 (no pain) to 10 (pain as bad as you can imagine). The AQA scores analgesic use from 0 (minimum) to 7 (maximum).
- Time to Deterioration in Health-Related Quality of Life (HRQoL) [ Time Frame: Randomization to the date of HRQoL deterioration (approximately 48 Months) ]Measured by the Functional Assessment of Cancer Therapy-Prostate (FACT-P; Physical well-being and Prostate Cancer Subscale). The FACT-P is a 39-item self-reported questionnaire that assesses physical well-being (7 items), social/family well-being (7 items), emotional well-being (6 items), functional well-being (7 items), and additional prostate cancer specific concerns (12 items). All items are scored from 0 (not at all) to 4 (very much). The total FACT-P score ranges from 0-156, with higher scores representing a better quality of life.
- Pharmacokinetics (PK): Mean Steady State Exposure of Abemaciclib [ Time Frame: Postdose Cycle 1 Day 1 through Predose Cycle 3 Day 1 (28 Day Cycles) ]PK: Mean steady state exposure of abemaciclib
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Adenocarcinoma of the prostate (as the predominant histology)
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High-risk metastatic hormone-sensitive prostate cancer. High risk is defined as:
- Greater than or equal to (≥)4 bone metastases by bone scan and/or
- ≥1 visceral metastases by computed tomography or magnetic resonance imaging
- Must have initiated androgen deprivation therapy (ADT) with luteinizing hormone-releasing hormone (LHRH) agonist/antagonist or bilateral orchiectomy prior to randomization. Up to 3 months of ADT prior to randomization is permitted with or without first-generation anti-androgen.
- Adequate organ function
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Exclusion Criteria:
- Prior treatment with abemaciclib or any other cyclin dependent kinase 4 and 6 (CDK4 & 6) inhibitor
- Development of metastatic prostate cancer in the context of castrate levels of testosterone
- Received any prior systemic therapy for metastatic prostate cancer (including investigational agents), except for ADT and first-generation anti-androgen
- Clinically significant cardiovascular disease as evidenced by myocardial infarction, arterial thrombotic events, or severe/unstable angina in the past 6 months, or New York Heart Association Class II to IV heart failure
- History of syncope of cardiovascular etiology, ventricular arrhythmia of pathological origin, or sudden cardiac arrest. Chronic and hemodynamically stable atrial arrhythmia well-controlled on medical therapy is permitted
- Uncontrolled hypertension
- Clinically active or chronic liver disease, moderate/severe hepatic impairment
- Known untreated central nervous system (CNS) metastasis. Participants with a history of treated brain metastases are eligible if stable for at least 8 weeks prior to randomization and off corticosteroid for at least 2 weeks prior to randomization
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05288166
Study Director: | Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company |
Responsible Party: | Eli Lilly and Company |
ClinicalTrials.gov Identifier: | NCT05288166 |
Other Study ID Numbers: |
18448 I3Y-MC-JPEG ( Other Identifier: Eli Lilly and Company ) 2022-500461-28-06 ( Other Identifier: EU Trial Number ) |
First Posted: | March 21, 2022 Key Record Dates |
Last Update Posted: | April 18, 2024 |
Last Verified: | April 2024 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement. |
Supporting Materials: |
Study Protocol Statistical Analysis Plan (SAP) Clinical Study Report (CSR) |
Time Frame: | Data are available 6 months after the primary publication and approval of the indication studied in the US and European Union (EU), whichever is later. Data will be indefinitely available for requesting. |
Access Criteria: | A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement. |
URL: | https://vivli.org/ |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Metastatic Hormone Sensitive Prostate Cancer mHSPC Stage IV Prostate Cancer Recurrent Prostate Cancer De Novo Metastatic Prostate Cancer High-Risk |
Visceral metastasis Cyclin-Dependent Kinase 4 (CDK4) Cyclin-Dependent Kinase 6 (CDK6) CDK4 CDK6 CDK4/6 |
Prostatic Neoplasms Neoplasms Neoplasm Metastasis Urogenital Neoplasms Hypersensitivity Genital Neoplasms, Male Neoplasms by Site Genital Diseases, Male Genital Diseases Urogenital Diseases Prostatic Diseases Male Urogenital Diseases Neoplastic Processes |
Pathologic Processes Immune System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Prednisone Prednisolone Anti-Inflammatory Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Antineoplastic Agents, Hormonal Antineoplastic Agents |