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Prostate CancerPhase 2/3CYCLONE 2NCT03706365

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

A Phase 2/3 study testing Abemaciclib, Abiraterone acetate and Prednisone in people with Prostate Cancer, run by Eli Lilly and Company at 112 sites in 11 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Prostate Cancer
What is being tested?
Abemaciclib, Abiraterone acetate and Prednisone
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
393 participants
Where
112 sitesin 11 countries
Study dates
26 Nov 2018to Dec 2026
Phase
Phase 2/3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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).

Trial locations and contacts

112 sites in 11 countries.

112 sites in 11 countries

United States33 sites

  • New York Oncology Hematology (NYOH) - Clifton Park Cancer Center

    Albany, New York, 12206

  • Northside Hospital

    Atlanta, Georgia, 30342

  • CBCC Global Research, Inc.

    Bakersfield, California, 93309

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • The University of Vermont Medical Center Inc.

    Burlington, Vermont, 05405

  • Fort Wayne Medical Oncology And Hematology at Parkview Comprehensive Cancer Center

    Fort Wayne, Indiana, 46804

  • Providence St. Jude Medical Center

    Fullerton, California, 92835

  • Millennium Oncology - Hollywood

    Hollywood, Florida, 33024

  • St. Bernards Medical Center

    Jonesboro, Arkansas, 72401

  • Moores Cancer Center

    La Jolla, California, 92093

  • Comprehensive Cancer Centers of Nevada

    Las Vegas, Nevada, 89119

  • Rocky Mountain Cancer Center

    Lone Tree, Colorado, 80124

  • TRIO-US (Translational Research in Oncology-US)

    Los Angeles, California, 90024

  • UCLA Hematology/Oncology - Westwood (Building 100)

    Los Angeles, California, 90095

  • M Health Fairview University of Minnesota Medical Center - East Bank

    Minneapolis, Minnesota, 55455

  • Pacific Cancer Care

    Monterey, California, 93940

  • Research Medical Center

    Nashville, Tennessee, 37203

  • St. Joseph's Hospital and Medical Center

    Phoenix, Arizona, 85004

  • Mayo Clinic in Arizona - Phoenix

    Phoenix, Arizona, 85054

  • Huntsman Cancer Institute

    Salt Lake City, Utah, 84112

  • Sansum Clinic_Kendle

    Santa Barbara, California, 93105

  • Associated Medical Professionals - Urology

    Syracuse, New York, 13210

  • Baylor Scott & White Medical Center - Temple

    Temple, Texas, 76508

  • New York Oncology Hematology (NYOH) - Clifton Park Cancer Center

    The Woodlands, Texas, 77380

  • Northwest Cancer Specialists PC

    The Woodlands, Texas, 77380

  • Sansum Clinic_Kendle

    The Woodlands, Texas, 77380

  • Texas Oncology - Longview Cancer Center

    The Woodlands, Texas, 77380

  • Texas Oncology Cancer Care and Research Center

    The Woodlands, Texas, 77380

  • Texas Oncology Fort Worth

    The Woodlands, Texas, 77380

  • Texas Oncology-Memorial City

    The Woodlands, Texas, 77380

  • US Oncology

    The Woodlands, Texas, 77380

  • USO-Cancer Care Center of Brevard, Inc.

    The Woodlands, Texas, 77380

  • The University of Arizona Cancer Center - North Campus

    Tucson, Arizona, 85719

Other trials in United States

China26 sites

  • Jilin Province People's Hospital

    Changchun, Jilin, 130021

  • Hunan Provincial People's Hospital

    Changsha, Hunan, 410005

  • Hunan Cancer Hospital

    Changsha, Hunan, 410013

  • Sun Yat-Sen University Cancer Centre

    Guangzhou, Guangdong, 510060

  • The First Affiliated Hospital, Zhejiang University

    Hangzhou, Zhejiang, 310003

  • Zhejiang Provincial People's Hospital

    Hangzhou, Zhejiang, 310014

  • Harbin Medical University Cancer Hospital

    Harbin, Heilongjiang, 150081

  • Second Affiliated hospital of Anhui Medical University

    Hefei, Anhui, 230000

  • Lanzhou university second hospital

    Lanzhou, Gansu, 730030

  • The First Affiliated Hospital of Henan University of Science &Technology

    Luoyang, Henan, 471003

  • The First Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi, 330006

  • Nanchong Central Hospital

    Nanchong, Sichuan, 637000

  • Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical SchoolNanjing

    Nanjing, Jiangsu, 210000

  • Nantong Tumor Hospital

    Nantong, Jiangsu, 226361

  • Ningbo First Hospital

    Ningbo, Zhejiang, 315010

  • Fudan University Shanghai Cancer Center

    Shanghai, Shanghai Municipality, 200032

  • Huashan Hospital Affiliated Fudan University

    Shanghai, Shanghai Municipality, 200040

  • Tianjin Medical University Cancer Institute and Hospital

    Tianjin, Tianjin Municipality, 300060

  • The Second Hospital of Tianjin Medical University

    Tianjin, Tianjin Municipality, 300211

  • Xinjiang Medical University Cancer Hospital - Urumqi

    Ürümqi, Xinjiang, 830000

  • Wuhan Union Hospital

    Wuhan, Hubei, 430022

  • Tongji Hospital Tongji Medical,Science & Technology

    Wuhan, Hubei, 430030

  • Wannan Medical College Yijishan Hospital

    Wuhu, Anhui, 241001

  • Wuxi People's Hospital

    Wuxi, Jiangsu, 214023

  • The First Affiliated Hospital of Xi'an Jiaotong University

    Xi'an, Shaanxi, 710061

  • Yantai Yuhuangding Hospital

    Yantai, Shandong, 264099

Other trials in China

Japan13 sites

  • Gifu University Hospital

    Gifu, 501-1112

  • Hamamatsu University Hospital

    Hamamatsu, Shizuoka, 431-3192

  • Hirosaki University Hospital

    Hirosaki, Aomori, 036-8563

  • Saitama Prefectural Cancer Center

    Ina-machi, Saitama, 362-0806

  • Kanazawa University Hospital

    Kanazawa, Ishikawa-ken, 920-8641

  • Kobe City Medical Center General Hospital

    Kobe, Hyōgo, 650-0047

  • National Hospital Organization Kumamoto Medical Center

    Kumamoto, 860-0008

  • Japanese Red Cross Nagoya Daini Hospital

    Nagoya, Aichi-ken, 466-8650

  • Osaka International Cancer Institute

    Osaka, 541-8567

  • Toho University Sakura Medical Center

    Sakura, Chiba, 285-0841

  • Hokkaido University Hospital

    Sapporo, Hokkaido, 060-8648

  • Showa University Hospital

    Shinagawa, Tokyo, 142-8555

  • Yokohama City University Medical Center

    Yokohama, Kanagawa, 232-0024

Other trials in Japan

Germany9 sites

  • Studienzentrum Bayenthal Urologische Partnerschaft Köln

    Cologne, North Rhine-Westphalia, 50968

  • Private Practice - Dr. Ralf Eckert

    Eisleben Lutherstadt, Saxony-Anhalt, 06295

  • Gesundheitszentrum Holzminden

    Holzminden, Lower Saxony, 37603

  • Private Practice - Dr. Silvio Szymula

    Leipzig, Saxony, 4105

  • Urologie Neandertal - Praxis Mettmann

    Mettmann, North Rhine-Westphalia, 40822

  • Universitätsklinikum Münster - Albert Schweitzer Campus

    Münster, North Rhine-Westphalia, 48149

  • Studienpraxis Urologie

    Nürtingen, Baden-Wurttemberg, 72622

  • Universitaetsklinikum Tuebingen

    Tübingen, Baden-Wurttemberg, 72076

  • Private Practice - Dr. Stammel & Dr. Garcia

    Wesel, North Rhine-Westphalia, 46483

Other trials in Germany

Spain7 sites

  • Hospital Universitari Vall d'Hebron

    Barcelona, Barcelona [Barcelona], 8035

  • Hospital Clínic de Barcelona

    Barcelona, Catalunya [Cataluña], 8036

  • Instituto Catalan de Oncologia - Hospital Duran i Reynals

    Hospitalet, Barcelona [Barcelona], 8907

  • Hospital Universitario Ramón y Cajal

    Madrid, Madrid, Comunidad de, 28034

  • Hospital Universitario 12 de Octubre

    Madrid, Madrid, Comunidad de, 28041

  • Hospital General Universitario Gregorio Marañon

    Madrid, 28009

  • Hospital Universitario Virgen de la Victoria

    Málaga, Málaga, 29010

Other trials in Spain

Australia6 sites

  • Chris O'Brien Lifehouse

    Camperdown, New South Wales, 2050

  • Southside Cancer Care Centre

    Kogarah, New South Wales, 2228

  • Macquarie University

    Macquarie University, New South Wales, 2109

  • Peter MacCallum Cancer Centre

    Melbourne, Victoria, 3000

  • St Vincent's Hospital

    Melbourne, Victoria, 3065

  • Prince of Wales Hospital

    Randwick, New South Wales, 2031

Other trials in Australia

France6 sites

  • CHU de Bordeaux Hop St ANDRE

    Bordeaux, 33075

  • Henri Mondor Hospital

    Créteil, Île-de-France Region

  • CHD Vendee

    La Roche-sur-Yon, Vendée, 85000

  • Clinique Victor Hugo Le Mans

    Le Mans, Pays de la Loire Region, 72000

  • Centre Leon Berard

    Lyon, Auvergne-Rhône-Alpes, 69373

  • Centre de Cancérologie du Grand Montpellier

    Montpellier, Languedoc-Roussillon, 34070

Other trials in France

South Korea4 sites

  • Seoul National University Hospital

    Seoul, Seoul-teukbyeolsi [Seoul], 3080

  • Severance Hospital, Yonsei University Health System

    Seoul, Seoul-teukbyeolsi [Seoul], 3722

  • Samsung Medical Center

    Seoul, Seoul-teukbyeolsi [Seoul], 6351

  • Asan Medical Center

    Songpagu, Seoul-teukbyeolsi [Seoul], 5505

Other trials in South Korea

Netherlands3 sites

  • Canisius-Wilhelmina Ziekenhuis

    Nijmegen, Gelderland, 6532 SZ

  • Erasmus Medisch Centrum

    Rotterdam, South Holland, 3015 GD

  • St. Antonius Ziekenhuis, locatie Utrecht

    Utrecht, 3543 AZ

Other trials in Netherlands

Romania3 sites

  • Gral Medical Diagnostic Center

    Bucharest, 31422

  • Centrul de Oncologie "Sfântul Nectarie"

    Craiova, Dolj, 200542

  • Ovidius Clinical Hospital OCH

    Ovidiu, Constanța County, 905900

Other trials in Romania

Denmark2 sites

  • Rigshospitalet

    Copenhagen, Capital Region, 2100

  • Næstved Sygehus

    Næstved, Region Sjælland, 4700

Other trials in Denmark

About this study

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

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
Prostate Cancer
Being tested
Abemaciclib, Placebo, Abiraterone acetate, Prednisone
Keywords
Metastatic Castration Resistant Prostate Cancer, mCRPC
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AbemaciclibDrug

    Also called LY2835219

    Administered orally.

  • PlaceboDrug

    Administered orally.

  • Abiraterone acetateDrug

    Administered orally.

  • PrednisoneDrug

    Administered orally.

Study groups in NCT03706365
Study groupRoleWhat they receive
AbemaciclibExperimentalParticipants 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.
Receives: Drug: Abemaciclib; Drug: Abiraterone acetate; Drug: Prednisone
PlaceboPlacebo comparatorParticipants 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.
Receives: Drug: Placebo; Drug: Abiraterone acetate; Drug: Prednisone

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Radiographic Progression Free Survival (rPFS)

    The rPFS time is measured from the date of randomization to the earliest date of investigator determined radiographic disease progression (by objective radiographic disease assessment per response evaluation criteria in solid tumors (RECIST) version 1.1 for soft tissue AND/OR radionuclide bone scan using prostate cancer working group 3 -PCWG3 criteria for bone) or death from any cause, whichever occurs first.

    Measured: From Date of Randomization to Radiographic Disease Progression or Death from Any Cause (Up to 60 Months)

Secondary outcomes (11)

  1. Time to Prostate-Specific Antigen (PSA) Progression

    The PSA progression is defined as a greater than or equal to (>=) 25 percentage (%) increase and an absolute increase of >=2 nanogram/milliliter (ng/mL) above the nadir (or baseline value if baseline is the smallest on study), which is confirmed by a second value obtained 3 or more weeks later.

    Measured: From Date of Randomization to the Date of the First Observation of PSA Progression (Up to 60 Months)

  2. Radiographic Progression Free Survival (rPFS) Determined by Blinded Independent Central Review

    rPFS is defined as the time from the date of randomization to the earliest date of radiographic disease progression determined by blinded independent central review (BICR) or death from any cause, whichever occurs first.

    Measured: From Date of Randomization Until Radiographic Disease Progression or Death from Any Cause (Up to 60 Months)

  3. Objective Response Rate (ORR): Percentage of Participants With a Complete Response (CR) or Partial Response (PR)

    ORR is a summary measure of best overall response (BOR) as defined by RECIST 1.1 for soft tissue per investigator assessment. BOR is derived from time point responses. All time point responses observed while on study treatment and during the short-term follow-up period (but before the initiation of post-discontinuation systemic anticancer therapy) will be included in the derivation.

    Each patient's BOR will be categorized as complete response (CR), partial response (PR), stable disease (SD), progressive disease (PD), or not evaluable (NE). A BOR of CR or PR will require confirmation, but sensitivity analyses of response-based endpoints may be performed where confirmation of a BOR of CR or PR is not required.

    Measured: Baseline to Radiographic Disease Progression (Up to 60 Months)

  4. Duration of Response (DOR)

    The DoR time is defined only for responders (participants with a soft tissue BOR of CR or PR) in the measurable disease population. It is measured from the date of first evidence of soft tissue CR or PR to the earliest date of investigator determined radiographic disease progression or death from any cause, whichever is earlier.

    Measured: Date of First Documented CR or PR to Date of Radiographic Disease Progression or Death from Any Cause (Up to 60 Months)

  5. Overall Survival (OS)

    The OS time is measured from the date of randomization to the date of death from any cause. If the participant was alive or lost to follow-up at the time of data analysis, OS data were censored on the last date the participant was known to be alive.

    Measured: From Date of Randomization to Date of Death Due to Any Cause (Up to 60 Months)

  6. Time to Symptomatic Progression

    Time to symptomatic progression is defined as the time from randomization to any of the following (whichever occurs earlier):

    1. Symptomatic Skeletal Event (SSE), defined as symptomatic fracture, surgery or radiation to bone, or spinal cord compression.
    2. Pain progression or worsening of disease-related symptoms requiring initiation of a new systemic anti-cancer therapy.
    3. Development of clinically significant symptoms due to loco-regional tumor progression requiring surgical intervention or radiation therapy.

    Measured: From Randomization to the Date of the First Documented Symptomatic Progression (Up to 60 Months)

  7. Pharmacokinetics (PK): Mean Steady State Exposure of Abemaciclib

    PK: Mean steady state exposure of abemaciclib.

    Measured: Cycle (C) 1 Day (D) 1: Predose, 30 min post-dose; C1 D15, C2 D1, C2 D15, C3 D1: Post dose (28 Days Cycle)

  8. PK: Mean Steady State Exposure of Abemaciclib Metabolite LSN2839567

    PK: Mean steady state exposure of abemaciclib metabolite LSN2839567.

    Measured: C1 D1: Predose, 30 min post-dose; C1 D15, C2 D1, C2 D15, C3 D1: Post dose (28 Days Cycle)

  9. PK: Mean Steady State Exposure of Abemaciclib Metabolite LSN3106726

    PK: Mean steady state exposure of abemaciclib metabolite LSN3106726.

    Measured: C1 D1: Predose, 30 min post-dose; C1 D15, C2 D1, C2 D15, C3 D1: Post dose (28 Days Cycle)

  10. PK: Mean Steady State Exposure of Abiraterone Acetate

    PK: Mean Steady State Exposure of Abiraterone Acetate.

    Measured: C1 D15, Post dose

  11. Time to Worst Pain Progression

    Time to Worst Pain Progression defined as the time from randomization to any of the following (whichever occurs earlier): For participants without opioid use at baseline (World Health Organization-Analgesic Ladder-WHO-AL ≤ 2):- Worst pain progression (an increase of 2 points from baseline on the Worst Pain Numeric Rating Scale (NRS) item on 2 consecutive evaluations), Initiation of weak or strong opioids (WHO-AL ≥ 3); For participants with weak or strong opioid use at baseline (WHO-AL ≥ 3): Worst pain progression (an increase of 2 points from baseline on the Worst Pain NRS item on 2 consecutive evaluations) without concurrent decreased opioid use (a decrease in WHO-AL of 1 or more) -Increased opioid use (an increase in WHO-AL of 1 or more).

    Measured: From Randomization Through Follow-up (Up to 60 months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Oct 2018
  2. Study start26 Nov 2018
  3. Primary completion2 Jan 2024
  4. Study completionDec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
393 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03706365
Sponsor's protocol ID
16598
Other IDs
I3Y-MC-JPCM, 2016-004276-21, 2023-506777-36-00, 2023, 2016
Acronym
CYCLONE 2
Status last verified
Jul 2026
First submitted
18 Sep 2018
Last updated
7 Aug 2026
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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.
Expanded access
Available

Publications

  • Smith 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.

    PubMed 41167216

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Abemaciclib, Abiraterone acetate and Prednisone in people with Prostate Cancer, run by Eli Lilly and Company at 112 sites in 11 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 7 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 112 sites in United States, China, Japan, Germany, Spain and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Radiographic Progression Free Survival (rPFS) (time frame: From Date of Randomization to Radiographic Disease Progression or Death from Any Cause (Up to 60 Months)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03706365, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2026; AzTrials last refreshed its copy on 26 Oct 2026.

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