A Study of Abiraterone Acetate Plus Prednisone With or Without Abemaciclib (LY2835219) in Participants With Prostate Cancer

Prostate Cancer Clinical Trial

— CYCLONE 2  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03706365
• Other study ID #: 16598
• Secondary ID: I3Y-MC-JPCM2016-
• Status: Active, not recruiting
• Phase: Phase 2/Phase 3
• Start date: November 26, 2018
• Est. completion date: June 2026

Study information

• Verified date: April 2024
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 350
• Est. completion date: June 2026
• Est. primary completion date: January 2, 2024
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• Abemaciclib
Administered orally.
• Abiraterone Acetate
Administered orally.
• Prednisone
Administered orally.
• Placebo
Administered orally.

Locations

Country	Name	City	State
Australia	Chris O'Brien Lifehouse	Camperdown	New South Wales
Australia	Southside Cancer Care Centre	Kogarah	New South Wales
Australia	Macquarie University	Macquarie University	New South Wales
Australia	Peter MacCallum Cancer Centre	Melbourne	Victoria
Australia	St Vincent's Hospital	Melbourne	Victoria
Australia	Prince of Wales Hospital	Randwick	New South Wales
China	Jilin Province People's Hospital	Changchun	Jilin
China	Hunan Cancer Hospital	Changsha	Hunan
China	Hunan Provincial People's Hospital	ChangSha	Hunan
China	Sun Yat-Sen University Cancer Centre	Guangzhou	Guangdong
China	The First Affiliated Hospital, Zhejiang University	Hangzhou	Zhejiang
China	Harbin Medical University Cancer Hospital	Harbin	Heilongjiang
China	Second Affiliated hospital of Anhui Medical University	Hefei	Anhui
China	Lanzhou university second hospital	Lanzhou	Gansu
China	The First Affiliated Hospital of Henan University of Science &Technology	Luoyang	Henan
China	The First Affiliated Hospital of Nanchang University	Nanchang	Jiangxi
China	Nanchong Central Hospital	Nanchong	Sichuan
China	Nantong Tumor Hospital	Nantong	Jiangsu
China	Ningbo First Hospital	Ningbo	Zhejiang
China	Fudan University Shanghai Cancer Center	Shanghai	Shanghai
China	Huashan Hospital Affiliated Fudan University	Shanghai	Shanghai
China	The Second Hospital of Tianjin Medical University	Tianjin	Tianjin
China	Tianjin Medical University Cancer Institute and Hospital	Tianjin	Tianjin
China	Xinjiang Medical University Cancer Hospital - Urumqi	Urumqi	Xinjiang
China	Tongji Hospital Tongji Medical,Science & Technology	Wuhan	Hubei
China	Wuhan Union Hospital	Wuhan	Hubei
China	Wannan Medical College Yijishan Hospital	Wuhu	Anhui
China	Wuxi People's Hospital	Wuxi	Jiangsu
China	The First Affiliated Hospital of Xi'an Jiaotong University	Xi'an	Shaanxi
China	Yantai Yuhuangding Hospital	Yantai	Shandong
Denmark	Rigshospitalet	Copenhagen	Hovedstaden
Denmark	Næstved Sygehus	Næstved	Sjælland
France	CHU de Bordeaux Hop St ANDRE	Bordeaux
France	Christophe TOURNIGAND	Créteil	Île-de-France
France	CHD Vendee	La Roche-sur-Yon	Vendée
France	Clinique Victor Hugo Le Mans	Le Mans	Pays-de-la-Loire
France	Centre Leon Berard	Lyon CEDEX 08	Rhône-Alpes
France	Centre de Cancérologie du Grand Montpellier	Montpellier	Languedoc-Roussillon
Germany	Studienzentrum Bayenthal Urologische Partnerschaft Köln	Cologne	Nordrhein-Westfalen
Germany	Gesundheitszentrum Holzminden	Holzminden	Niedersachsen
Germany	Private Practice - Dr. Silvio Szymula	Leipzig	Sachsen
Germany	Private Practice - Dr. Ralf Eckert	Lutherstadt Eisleben	Sachsen-Anhalt
Germany	Urologie Neandertal - Praxis Mettmann	Mettmann	Nordrhein-Westfalen
Germany	Universitätsklinikum Münster - Albert Schweitzer Campus	Münster	Nordrhein-Westfalen
Germany	Studienpraxis Urologie	Nürtingen	Baden-Württemberg
Germany	Universitaetsklinikum Tuebingen	Tübingen	Baden-Württemberg
Germany	Private Practice - Dr. Stammel & Dr. Garcia	Wesel	Nordrhein-Westfalen
Japan	Gifu University Hospital	Gifu
Japan	Hamamatsu University Hospital	Hamamatsu	Shizuoka
Japan	Hirosaki University Hospital	Hirosaki	Aomori
Japan	Saitama Prefectural Cancer Center	Ina-machi	Saitama
Japan	Kobe City Medical Center General Hospital	Kobe	Hyogo
Japan	Japanese Red Cross Nagoya Daini Hospital	Nagoya	Aichi
Japan	Osaka International Cancer Institute	Osaka
Japan	Toho University Sakura Medical Center	Sakura	Chiba
Japan	Hokkaido University Hospital	Sapporo	Hokkaido
Japan	Showa University Hospital	Shinagawa	Tokyo
Japan	Yokohama City University Medical Center	Yokohama	Kanagawa
Korea, Republic of	Samsung Medical Center	Seoul	Seoul-teukbyeolsi [Seoul]
Korea, Republic of	Seoul National University Hospital	Seoul	Seoul-teukbyeolsi [Seoul]
Korea, Republic of	Severance Hospital, Yonsei University Health System	Seoul	Seoul-teukbyeolsi [Seoul]
Korea, Republic of	Asan Medical Center	Songpagu	Seoul-teukbyeolsi [Seoul]
Netherlands	Canisius-Wilhelmina Ziekenhuis	Nijmegen	Gelderland
Netherlands	St. Antonius Ziekenhuis, locatie Utrecht	Utrecht
Romania	Gral Medical Diagnostic Center	Bucure?ti
Romania	Centrul de Oncologie "Sfântul Nectarie"	Craiova	Dolj
Romania	Ovidius Clinical Hospital OCH	Ovidiu	Constan?a
Spain	Hospital Clínic de Barcelona	Barcelona	Catalunya [Cataluña]
Spain	Hospital Universitari Vall d'Hebron	Barcelona	Barcelona [Barcelona]
Spain	Instituto Catalan de Oncologia - Hospital Duran i Reynals	Hospitalet	Barcelona [Barcelona]
Spain	Hospital General Universitario Gregorio Marañon	Madrid
Spain	Hospital Universitario 12 de Octubre	Madrid	Madrid, Comunidad De
Spain	Hospital Universitario Virgen de la Victoria	Malaga	Málaga
United States	New York Oncology Hematology (NYOH) - Clifton Park Cancer Center	Albany	New York
United States	Northside Hospital	Atlanta	Georgia
United States	CBCC Global Research, Inc.	Bakersfield	California
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	The University of Vermont Medical Center Inc.	Burlington	Vermont
United States	Maryland Oncology Hematology - Columbia	Columbia	Maryland
United States	Fort Wayne Medical Oncology And Hematology at Parkview Comprehensive Cancer Center	Fort Wayne	Indiana
United States	St. Jude Medical Center	Fullerton	California
United States	Millennium Oncology - Hollywood	Hollywood	Florida
United States	St. Bernards Medical Center	Jonesboro	Arkansas
United States	Moores Cancer Center	La Jolla	California
United States	Comprehensive Cancer Centers of Nevada	Las Vegas	Nevada
United States	Rocky Mountain Cancer Center	Lone Tree	Colorado
United States	TRIO-US (Translational Research in Oncology-US)	Los Angeles	California
United States	UCLA Hematology/Oncology - Westwood (Building 100)	Los Angeles	California
United States	M Health Fairview University of Minnesota Medical Center - East Bank	Minneapolis	Minnesota
United States	Pacific Cancer Care	Monterey	California
United States	Research Medical Center	Nashville	Tennessee
United States	Mayo Clinic in Arizona - Phoenix	Phoenix	Arizona
United States	St. Joseph's Hospital and Medical Center	Phoenix	Arizona
United States	Huntsman Cancer Institute	Salt Lake City	Utah
United States	Sansum Clinic_Kendle	Santa Barbara	California
United States	Associated Medical Professionals - Urology	Syracuse	New York
United States	Baylor Scott & White Medical Center - Temple	Temple	Texas
United States	Northwest Cancer Specialists PC	The Woodlands	Texas
United States	Texas Oncology - Longview Cancer Center	The Woodlands	Texas
United States	Texas Oncology Cancer Care and Research Center	The Woodlands	Texas
United States	Texas Oncology Fort Worth	The Woodlands	Texas
United States	Texas Oncology-Memorial City	The Woodlands	Texas
United States	US Oncology	The Woodlands	Texas
United States	USO-Cancer Care Center of Brevard, Inc.	The Woodlands	Texas
United States	The University of Arizona Cancer Center - North Campus	Tucson	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Countries where clinical trial is conducted

United States,  Australia,  China,  Denmark,  France,  Germany,  Japan,  Korea, Republic of,  Netherlands,  Romania,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Radiographic Progression Free Survival (rPFS)	rPFS by investigator assessment	Baseline to Radiographic Disease Progression or Death from Any Cause (Estimated up to 21 Months)
Secondary	Time to Prostate-Specific Antigen (PSA) Progression	Time to PSA progression	Baseline to the Date of the First Observation of PSA Progression (Estimated up to 21 Months)
Secondary	Radiographic Progression Free Survival (rPFS)	rPFS by blinded, independent, central review	Baseline to Radiographic Disease Progression or Death from Any Cause (Estimated up to 21 Months)
Secondary	Objective Response Rate (ORR): Percentage of Participants with a Complete Response (CR) or Partial Response (PR)	ORR: Percentage of participants with a CR or PR	Baseline to Radiographic Disease Progression (Estimated up to 21 Months)
Secondary	Duration of Response (DOR)	DOR	Date of First Documented CR or PR to Date of Radiographic Disease Progression or Death from Any Cause (Estimated up to 21 Months)
Secondary	Overall Survival (OS)	OS	Baseline to Date of Death Due to Any Cause (Estimated up to 40 Months)
Secondary	Time to Symptomatic Progression	Time to symptomatic progression	Baseline to the Date of the First Documented Symptomatic Progression (Estimated up to 21 Months)
Secondary	Pharmacokinetics (PK): Mean Steady State Exposure of Abemaciclib	PK: Mean steady state exposure of abemaciclib	Postdose Cycle 1 Day 1 through Postdose Cycle 3 Day 1 (28 Day Cycles)
Secondary	PK: Mean Steady State Exposure of Abemaciclib Metabolite LSN2839567	PK: Mean steady state exposure of abemaciclib metabolite LSN2839567	Postdose Cycle 1 Day 1 through Postdose Cycle 3 Day 1 (28 Day Cycles)
Secondary	PK: Mean Steady State Exposure of Abemaciclib Metabolite LSN3106726	PK: Mean steady state exposure of abemaciclib metabolite LSN3106726	Postdose Cycle 1 Day 1 through Postdose Cycle 3 Day 1 (28 Day Cycles)
Secondary	PK: Mean Steady State Exposure of Abiraterone Acetate	PK: Mean Steady State Exposure of Abiraterone Acetate	Postdose Cycle 1 Day 1 through Postdose Cycle 3 Day 1 (28 Day Cycles)
Secondary	Time to Worst Pain Progression	Measured by the Worst Pain Numeric Rating Scale (NRS) and World Health Organization-Analgesic Ladder (WHO-AL). NRS score measures worst pain over the last 24 hours on a 0 to 10-point NRS, where 0 -s "no pain" and 10 is "pain as bad as you can imagine. The WHO-AL classifies analgesic use into four categories, where 1 = no analgesic and 4 = strong opioids.	Baseline through follow-up (Estimated up to 21 months)

External Links

•   A Study of Abiraterone Acetate Plus Prednisone With or Without Abemaciclib (LY2835219) in Participants With Prostate Cancer