Clinical trial • Phase II/III • Oncology
ABEMACICLIB for Prostate cancer | Metastatic castration-resistant prostate cancer
Phase II/III trial of ABEMACICLIB for Prostate cancer | Metastatic castration-resistant prostate cancer.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Prostate cancer | Metastatic castration-resistant prostate cancer
- Trial Stage
- Phase II/III
- Drug Modality
- Small molecule
Key dates
- Initial CTIS Submission Date
- 10-01-2024
- First CTIS Authorization Date
- 19-02-2024
Trial design
Randomised, abiraterone acetate plus prednisone (comparator products listed: abiraterone — product entry with maxdailydoseamount 1000 mg; prednisone/prednisolone — product entries with maxdailydoseamount 10 mg). placebo to match ly2835219 (abemaciclib) tablets/capsules used as placebo control for the abemaciclib component., adaptive Phase II/III trial in Denmark, Netherlands, Romania and others.
- Randomised
- Yes
- Comparator
- Abiraterone acetate plus prednisone (comparator products listed: ABIRATERONE — product entry with maxDailyDoseAmount 1000 mg; PREDNISONE/PREDNISOLONE — product entries with maxDailyDoseAmount 10 mg). Placebo to match LY2835219 (Abemaciclib) tablets/capsules used as placebo control for the abemaciclib component.
- Adaptive
- True, Part 1 is a dose-finding component to determine the RP2D of abemaciclib in combination with abiraterone acetate and prednisone (dose-escalation elements described as Part 1 objective). Specific escalation dose levels or numeric escalation rules are not specified in the CTIS JSON.
- Single Multiple Or Escalation Dose Combined
- Yes
- Target Sample Size
- 221
- Trial Duration For Participant
- 380
Eligibility
Recruits 221 No vulnerable populations selected. Trial population comprises adult male participants only (isMaleSubjects=true; isFemaleSubjects=false). Informed consent is obtained from adult participants (adult ICF documents listed in the CTIS documents). No paediatric/assent procedures are indicated in the CTIS record..
- Vulnerable Population
- No vulnerable populations selected. Trial population comprises adult male participants only (isMaleSubjects=true; isFemaleSubjects=false). Informed consent is obtained from adult participants (adult ICF documents listed in the CTIS documents). No paediatric/assent procedures are indicated in the CTIS record.
Inclusion criteria
- {"criterion_text":"- Histologically confirmed adenocarcinoma of the prostate.\n- Metastatic prostate cancer documented by positive bone scan and/or measurable soft tissue metastatic lesions by CT or magnetic resonance imaging (MRI).\n- 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\n- Have adequate organ function.\n- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1."}
Exclusion criteria
- {"criterion_text":"- Prior therapy with cytochrome P450 (CYP)17 inhibitors.\n- Prior treatment with abemaciclib or any cyclin-dependent kinase (CDK) 4 & 6 inhibitors.\n- 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.\n- Currently enrolled in a clinical study involving an investigational product.\n- Gastrointestinal disorder affecting the absorption or ability to swallow large pills.\n- Clinically significant heart disease, active or chronic liver disease, moderate/severe hepatic impairment (Child-Pugh Class B and C)."}
Endpoints
Primary endpoints
- {"endpoint_text":"- Radiographic Progression Free Survival (rPFS)","definition_or_measurement_approach":"Radiographic progression as assessed per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 for soft tissue disease and/or per Prostate Cancer Working Group 3 (PCWG3) criteria for bone disease; rPFS compared between arms."}
Recruitment
- Planned Sample Size
- 221
- Recruitment Window Months
- 89
- Consent Approach
- Informed consent obtained from adult participants via adult informed consent forms (ICFs). CTIS lists multiple ICF/subject information documents including adult ICFs and language-specific versions; available language indications in CTIS documents/translations include French, Spanish, Dutch and Danish (documents labelled FR/ES/NL/DK and language translations in the record). No assent/minor consent indicated.
Methods
- Study development/conduct activities including patient referral, screening, recruitment and retention performed by third party (Publicis Healthcare Communications Group Limited) as listed in sponsor third parties (duty: Study Development/Conduct - Patient Referral, Screening, Recruitment, and Retention).
- Site-based recruitment at participating hospitals/clinics listed in the CTIS trial sites; sponsor public contact (Lilly Clinical Trials information desk EU_lilly_clinical_trials@lilly.com) provided for interested participants/inquiries.
Geography
- Total Number Of Sites
- 22
- Total Number Of Participants
- 83
Denmark
- Earliest CTIS Part Ii Submission Date
- 23-01-2024
- Latest Decision Or Authorization Date
- 04-06-2025
- Processing Time Days
- 498
- Number Of Sites
- 2
- Number Of Participants
- 5
Sites
- Site Name
- Rigshospitalet
- Department Name
- No Department
- Contact Person Name
- Gedske Daugaard
- Contact Person Email
- kirsten.gedske.daugaard@regionh.dk
- Site Name
- Næstved Hospital
- Department Name
- Oncology
- Contact Person Name
- Anne Christensen
- Contact Person Email
- anjc@regionsjaelland.dk
Netherlands
- Earliest CTIS Part Ii Submission Date
- 23-01-2024
- Latest Decision Or Authorization Date
- 05-06-2025
- Processing Time Days
- 499
- Number Of Sites
- 3
- Number Of Participants
- 8
Sites
- Site Name
- Canisius Wilhelmina Hospital
- Department Name
- Oncology
- Contact Person Name
- Diederik Somford
- Contact Person Email
- r.somford@cwz.nl
- Site Name
- Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
- Department Name
- Medical Oncology
- Contact Person Name
- Ronald De Wit
- Contact Person Email
- r.dewit@erasmusmc.nl
- Site Name
- St. Antonius Ziekenhuis
- Department Name
- Internal Medicine
- Contact Person Name
- Maartje Los
- Contact Person Email
- r.los@saz.nl
Romania
- Earliest CTIS Part Ii Submission Date
- 23-01-2024
- Latest Decision Or Authorization Date
- 26-02-2024
- Processing Time Days
- 34
- Number Of Sites
- 3
- Number Of Participants
- 9
Sites
- Site Name
- Centrul De Oncologie SF Nectarie S.R.L.
- Department Name
- Oncology
- Contact Person Name
- Michael Schenker
- Contact Person Email
- mike_schenker@yahoo.com
- Site Name
- Gral Medical S.R.L.
- Department Name
- Oncology
- Contact Person Name
- Cristina Tiut
- Contact Person Email
- dr.cristinatiut@gmail.com
- Site Name
- Ovidius Clinical Hospital S.R.L.
- Department Name
- Oncology
- Contact Person Name
- Laura Mazilu
- Contact Person Email
- lauragrigorov@gmail.com
France
- Earliest CTIS Part Ii Submission Date
- 23-01-2024
- Latest Decision Or Authorization Date
- 05-06-2025
- Processing Time Days
- 499
- Number Of Sites
- 5
- Number Of Participants
- 5
Sites
- Site Name
- Centre De Cancerologue Du Grand Montpellier
- Department Name
- Oncology
- Contact Person Name
- Mathieu Grapin
- Contact Person Email
- m.grapin@oncoclem.org
- Site Name
- Assistance Publique Hopitaux De Paris
- Department Name
- Medical oncology
- Contact Person Name
- Christophe Tournigand
- Contact Person Email
- christophe.tournigand@aphp.fr
- Site Name
- Clinique Victor Hugo (Centre De Cancerologie De La Sarthe)
- Department Name
- Oncology-Radiotherapy
- Contact Person Name
- Amandine Ruffier
- Contact Person Email
- essaisruffier@ilcgroupe.fr
- Site Name
- Centre Leon Berard
- Department Name
- Oncology
- Contact Person Name
- Aude Flechon
- Contact Person Email
- aude.flechon@lyon.unicancer.fr
- Site Name
- Centre Hospitalier Departemental Vendee
- Department Name
- onco-hematologie
- Contact Person Name
- Frank Priou
- Contact Person Email
- frank.priou@ght85.fr
Spain
- Earliest CTIS Part Ii Submission Date
- 23-01-2024
- Latest Decision Or Authorization Date
- 04-06-2025
- Processing Time Days
- 498
- Number Of Sites
- 7
- Number Of Participants
- 33
Sites
- Site Name
- Hospital Universitario Virgen De La Victoria
- Department Name
- Oncology
- Contact Person Name
- Lucia Oliva Fernandez
- Contact Person Email
- luciaolifer3@gmail.com
- Site Name
- Institut Catala D'oncologia
- Department Name
- Medical Oncology
- Contact Person Name
- Josep Piulats Rodriguez
- Contact Person Email
- jmpiulats@iconcologia.net
- Site Name
- Hospital General Universitario Gregorio Maranon
- Department Name
- Oncology
- Contact Person Name
- Jose Arranz Arija
- Contact Person Email
- jarranza.oncomed@gmail.com
- Site Name
- Hospital Universitario Ramon Y Cajal
- Department Name
- Medical Oncology
- Contact Person Name
- Teresa Alonso Gordoa
- Contact Person Email
- talonsogordoa@gmail.com
- Site Name
- Hospital Universitari Vall D Hebron
- Department Name
- Oncology
- Contact Person Name
- Joan Carles Galceran
- Contact Person Email
- jcarles@vhio.net
- Site Name
- Hospital Universitario 12 De Octubre
- Department Name
- Medical Oncology
- Contact Person Name
- Guillermo de Velasco Oria de Rueda
- Contact Person Email
- gdevelasco.gdv@gmail.com
- Site Name
- Hospital Clinic De Barcelona
- Department Name
- Oncology
- Contact Person Name
- Begona Mellado Gonzalez
- Contact Person Email
- bmellado@clinic.cat
Sponsor
Primary sponsor
- Full Name
- Eli Lilly & Co.
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- United States
Contract research organisations
- Name
- Iqvia Rds Inc.
- Responsibilities
- sponsorDuties codes: 1,5
- Name
- Ppd Inc.
- Responsibilities
- sponsorDuties codes: 4
- Name
- Labcorp Central Laboratory Services LP
- Responsibilities
- sponsorDuties codes: 4
- Name
- Q2 Solutions LLC
- Responsibilities
- sponsorDuties codes: 4
Third parties
- {"country":"United States","full_name":"Azenta US Inc.","duties_or_roles":"sponsorDuties codes: 4","organisation_type":"Pharmaceutical company"}
- {"country":"United Kingdom","full_name":"Almac Clinical Services Limited","duties_or_roles":"sponsorDuties codes: 4","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Iqvia Rds Inc.","duties_or_roles":"sponsorDuties codes: 1, 5","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"RWS Life Sciences Inc.","duties_or_roles":"sponsorDuties codes: 6","organisation_type":"Pharmaceutical company"}
- {"country":"United Kingdom","full_name":"Publicis Healthcare Communications Group Limited","duties_or_roles":"Study Development/Conduct - Patient Referral, Screening, Recruitment, and Retention (code 15)","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United States","full_name":"Q2 Solutions LLC","duties_or_roles":"sponsorDuties codes: 4","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"United States","full_name":"Perceptive Informatics Inc.","duties_or_roles":"sponsorDuties codes: 4","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Precision for Medicine","duties_or_roles":"sponsorDuties codes: 4","organisation_type":"Industry"}
- {"country":"United States","full_name":"Labcorp Central Laboratory Services LP","duties_or_roles":"sponsorDuties codes: 4","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Target Health","duties_or_roles":"sponsorDuties codes: 6","organisation_type":"Industry"}
- {"country":"United States","full_name":"Greenphire LLC","duties_or_roles":"sponsorDuties codes: 15 (Clinical Trial Reimbursement)","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United States","full_name":"Ppd Inc.","duties_or_roles":"sponsorDuties codes: 4","organisation_type":"Pharmaceutical company"}
Investigational products
- Investigational Product Name
- Verzenios 50 mg film-coated tablets
- Active Substance
- ABEMACICLIB
- Modality
- Small molecule
- Routes Of Administration
- ORAL USE
- Route
- ORAL
- Authorisation Status
- Marketing authorisation: EU/1/18/1307/001
- Maximum Dose
- 400 mg (maxDailyDoseAmount 400)
- Investigational Product Name
- LY2835219 (Abemaciclib) sponsor product (capsule, hard) - sponsorProductCode LY2835219
- Active Substance
- ABEMACICLIB
- Modality
- Small molecule
- Routes Of Administration
- ORAL USE
- Route
- ORAL
- Maximum Dose
- 400 mg (maxDailyDoseAmount 400)
- Investigational Product Name
- ABIRATERONE
- Active Substance
- ABIRATERONE
- Modality
- Small molecule
- Routes Of Administration
- ORAL USE
- Route
- ORAL
- Maximum Dose
- 1000 mg (maxDailyDoseAmount 1000)
- Investigational Product Name
- PREDNISONE
- Active Substance
- PREDNISOLONE / PREDNISONE (glucocorticoid comparator)
- Modality
- Small molecule
- Routes Of Administration
- ORAL USE
- Route
- ORAL
- Maximum Dose
- 10 mg (maxDailyDoseAmount 10)
- Investigational Product Name
- BETAMETHASONE SODIUM PHOSPHATE
- Active Substance
- BETAMETHASONE SODIUM PHOSPHATE
- Modality
- Small molecule
- Routes Of Administration
- ORAL USE
- Route
- ORAL
- Maximum Dose
- 10 mg (maxDailyDoseAmount 10)
- Investigational Product Name
- Placebo to match LY2835219 (Abemaciclib) Tablets
- Modality
- Other
- Investigational Product Name
- Placebo to match LY2835219 (Abemaciclib) Capsules
- Modality
- Other
- Combination Treatment
- Yes
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