Overview
Sponsor-declared trial summary
Phase
Phase II and Phase III (Integrated)
Status
Ongoing, recruitment ended
Participants planned
304
Countries
6
Sites
22
Prostate Cancer
Part 1: To determine the RP2D of abemaciclib that may be safely administered to patients with mCRPC in combination with abiaterone acetate and prednisone. Part 1, 2 & 3: To compare the rPFS of patients receiving abiraterone acetate plus prednisone with or without abemaciclib.
Key facts
- Sponsor
- Eli Lilly & Co.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 4 Jan 2019 → ongoing
- Decision date (initial)
- 2024-02-19
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2023-506777-36-00
- EudraCT number
- 2016-004276-21
- WHO UTN
- U1111-1300-2177
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy, Pharmacodynamic, Pharmacogenomic, Efficacy, Safety, Pharmacogenetic, Pharmacokinetic
Part 1: To determine the RP2D of abemaciclib that may be safely administered to patients with mCRPC in combination with abiaterone acetate and prednisone.
Part 1, 2 & 3: To compare the rPFS of patients receiving abiraterone acetate plus prednisone with or without abemaciclib.
Conditions and MedDRA coding
Prostate Cancer
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 5
- 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 6
- 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).
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Radiographic Progression Free Survival (rPFS)
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 2
PRD1578434 · Product
- Active substance
- Abemaciclib
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL USE
- Max daily dose
- 400 mg milligram(s)
- Max total dose
- 1064 g gram(s)
- Max treatment duration
- 380 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- ELI LILLY AND COMPANY
- Paediatric formulation
- No
- Orphan designation
- No
Verzenios 50 mg film-coated tablets
PRD6701098 · Product
- Active substance
- Abemaciclib
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 400 mg milligram(s)
- Max total dose
- 1064 g gram(s)
- Max treatment duration
- 380 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01EF03 — -
- Marketing authorisation
- EU/1/18/1307/001
- MA holder
- ELI LILLY NEDERLAND B.V.
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Different primary packaging (bottles) than in marketing authorisation and clinical trial specific packaging and labeling.
Comparator 3
SCP131338 · ATC
- Active substance
- Prednisolone
- Substance synonyms
- (8S,9S,10S,11S,13S,14S,17R)-11,17-DIHYDROXY-17-(2-HYDROXYACETYL)-10,13-DIMETHYL-7,8,9,11,12,14,15,16-OCTAHYDRO-6H-CYCLOPENTA[A]PHENANTHREN-3-ONE, GLPG0303, DELTA-HYDROCORTISONE, 1,2-DEHYDROHYDROCORTISONE, METACORTANDRALONE
- Route of administration
- ORAL USE
- Max daily dose
- 10 mg milligram(s)
- Max total dose
- 26.6 g gram(s)
- Max treatment duration
- 380 Week(s)
- Authorisation status
- Authorised
- ATC code
- H02AB07 — PREDNISONE
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP132446 · ATC
- Active substance
- Abiraterone
- Route of administration
- ORAL USE
- Max daily dose
- 1000 mg milligram(s)
- Max total dose
- 2660 g gram(s)
- Max treatment duration
- 380 Week(s)
- Authorisation status
- Authorised
- ATC code
- L02BX03 — ABIRATERONE
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Betamethasone Sodium Phosphate
SCP1158234 · ATC
- Active substance
- Betamethasone Sodium Phosphate
- Substance synonyms
- BETAMETHASONE DISODIUM PHOSPHATE
- Route of administration
- ORAL USE
- Max daily dose
- 10 mg milligram(s)
- Max total dose
- 26.6 g gram(s)
- Max treatment duration
- 380 Week(s)
- Authorisation status
- Authorised
- ATC code
- H02AB06 — PREDNISOLONE
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Placebo 2
Placebo to match LY2835219 (Abemaciclib) Tablets
N/A · Product
- Other product name
- N/A
- Pharmaceutical form
- N/A
- ATC code
- N/A — N/A
- Marketing authorisation
- N/A
- MA holder
- N/A
- MA country
- Iceland
- Paediatric formulation
- No
Placebo to match LY2835219 (Abemaciclib) Capsules
N/A · Product
- Other product name
- N/A
- Pharmaceutical form
- N/A
- ATC code
- N/A — N/A
- Marketing authorisation
- N/A
- MA holder
- N/A
- MA country
- Iceland
- Paediatric formulation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Eli Lilly & Co.
- Sponsor organisation
- Eli Lilly & Co.
- Address
- 1 Lilly Corporate Center
- City
- Indianapolis
- Postcode
- 46285-0001
- Country
- United States
Scientific contact point
- Organisation
- Eli Lilly & Co.
- Contact name
- Lilly Clinical Trials information desk
Public contact point
- Organisation
- Eli Lilly & Co.
- Contact name
- Lilly Clinical Trials information desk
Third parties 12
| Organisation | City, country | Duties |
|---|---|---|
| Azenta US Inc. ORG-100012907
|
Indianapolis, United States | Laboratory analysis |
| Almac Clinical Services Limited ORG-100017464
|
Craigavon, United Kingdom (Northern Ireland) | Laboratory analysis |
| Iqvia Rds Inc. ORG-100043858
|
Durham, United States | On site monitoring, Code 5 |
| RWS Life Sciences Inc. ORG-100042348
|
East Hartford, United States | Data management |
| Publicis Healthcare Communications Group Limited ORG-100044665
|
London, United Kingdom | Other |
| Q2 Solutions LLC ORG-100017000
|
Ithaca, United States | Laboratory analysis |
| Perceptive Informatics Inc. ORG-100013171
|
Billerica, United States | Laboratory analysis |
| Precision for Medicine ORL-000004705
|
Houston, United States | Laboratory analysis |
| Labcorp Central Laboratory Services LP ORG-100032236
|
Indianapolis, United States | Laboratory analysis |
| Target Health ORL-000004704
|
Carlstadt, United States | Data management |
| Greenphire LLC ORG-100041621
|
King Of Prussia, United States | Other |
| Ppd Inc. ORG-100018960
|
Middleton, United States | Laboratory analysis |
Locations
6 EU/EEA countries · 22 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Denmark | Ended | 5 | 2 |
| France | Ongoing, recruitment ended | 5 | 5 |
| Germany | Ongoing, recruitment ended | 23 | 2 |
| Netherlands | Ended | 8 | 3 |
| Romania | Ended | 9 | 3 |
| Spain | Ongoing, recruitment ended | 33 | 7 |
| Rest of world
Japan, United States, Australia, United Kingdom, China, Korea, Republic of
|
— | 221 | — |
Investigational sites
Rigshospitalet
No Department, Blegdamsvej 9, 2100, Copenhagen Oe
Næstved Hospital
Oncology, Ringstedgade 61, 4700, Næstved
Centre De Cancerologue Du Grand Montpellier
Oncology, 25 Rue De Clementville, 34070, Montpellier
Centre Hospitalier Departemental Vendee
onco-hematologie, Boulevard Stephane Moreau, 85925, La Roche Sur Yon Cedex 9
Clinique Victor Hugo
Oncology-Radiotherapy, Centre De Cancerologie De La Sarthe, 64 Rue De Degre, Le Mans
Centre Leon Berard
Oncology, 28 Rue Laennec, 69008, Lyon
Assistance Publique Hopitaux De Paris
Medical oncology, 51 Avenue Du Mal De Lattre De Tassigny, 94010, Creteil Cedex
Studienpraxis Urologie Susan Feyerabend MD Tilman Todenhoefer MD PhD GbR
Urologie, Steinengrabenstrasse 17, 72622, Nuertingen
Gesundheitszentrum Holzminden
N/A, Nordstrasse 8, Niedersachsen, Holzminden
Canisius Wilhelmina Hospital
Oncology, Weg Door Jonkerbos 100, 6532 SZ, Nijmegen
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Medical Oncology, Dr. Molewaterplein 40, 3015 GD, Rotterdam
St. Antonius Ziekenhuis
Internal Medicine, Soestwetering 1, 3543 AZ, Utrecht
Centrul De Oncologie SF Nectarie S.R.L.
Oncology, Strada Caracal Nr 109, 200542, Craiova
Ovidius Clinical Hospital S.R.L.
Oncology, Dn 2a Km 202 880, 905900, Ovidiu
Gral Medical S.R.L.
Oncology, Strada Popovici Traian 79-91, 031422, Bucharest
Hospital Clinic De Barcelona
Oncology, Calle Villarroel 170, 08036, Barcelona
Hospital Universitario 12 De Octubre
Medical Oncology, Bloque D, Avenida De Cordoba Sn, Madrid
Hospital General Universitario Gregorio Maranon
Oncology, Calle Del Doctor Esquerdo 46, 28007, Madrid
Hospital Universitario Ramon Y Cajal
Medical Oncology, Carretera Del Colmenar Viejo Km 9 100, Por El Pardo, Madrid
Institut Catala D'oncologia
Medical Oncology, Avinguda De La Gran Via De L'hospitalet 199-203, 08908, L'hospitalet De Llobregat
Hospital Universitario Virgen De La Victoria
Oncology, Calle Del Arroyo Teatinos Sn, 29010, Malaga
Hospital Universitari Vall D Hebron
Oncology, Edificio Materno-Infantil, Passeig De La Vall D'hebron 119-129, Barcelona
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Denmark | 2019-03-04 | 2025-12-08 | 2019-10-07 | 2022-03-02 | |
| France | 2021-10-12 | 2021-10-25 | 2022-03-04 | ||
| Germany | 2019-01-16 | 2019-02-04 | 2022-03-23 | ||
| Netherlands | 2019-03-14 | 2026-05-12 | 2019-03-26 | 2022-02-02 | |
| Romania | 2019-01-04 | 2024-05-14 | 2019-02-26 | 2022-03-03 | |
| Spain | 2019-02-08 | 2019-02-11 | 2022-03-17 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 39 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol 2023-506777-36-00_Redacted | f |
| Protocol (for publication) | D4_JPCM_Patient Documents Copyright | 1 |
| Recruitment arrangements (for publication) | Blank document for Recruitment Arrangement_Recruitment closed | 1 |
| Recruitment arrangements (for publication) | Blank document for Recruitment Arrangement_Recruitment closed | 1 |
| Recruitment arrangements (for publication) | Blank document for Recruitment Arrangement_Recruitment closed | 1 |
| Recruitment arrangements (for publication) | Blank document for Recruitment Arrangement_Recruitment closed | 1 |
| Recruitment arrangements (for publication) | Blank document for Recruitment Arrangement_Recruitment closed | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements_List of participating sites and investigators_FR_Redacted | 3 |
| Subject information and informed consent form (for publication) | L1_ICF Addendum Summary_FR_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_ICF Adult_FR_Redacted | 3 |
| Subject information and informed consent form (for publication) | L1_ICF Amendment Summary_Redacted | 9.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Adultos Parte 1_Redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Adultos Parte 2y3 Summary_Redacted | 9.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Adultos Parte 2y3_Redacted | 8.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_Redacted | 10 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Summary of Changes | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Addendum | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_ICF Amendment Summary_Redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Informed consent form Summary of Changes | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF_Redacted | 7.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Patient Reimbursement Program_Greenphire_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_SoC | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and Main ICF_Redacted | 8.0 |
| Subject information and informed consent form (for publication) | L1_SIS_ICF Summary _Redacted | 11 |
| Subject information and informed consent form (for publication) | L1_Travel Reimbursement ICF_Redacted | 1 |
| Subject information and informed consent form (for publication) | L2_ Other subject information material_Diarrhoea Factcard_FR | 1 |
| Subject information and informed consent form (for publication) | L2_ Other subject information material_Medication Guidance_FR | 5a |
| Subject information and informed consent form (for publication) | L2_ Other subject information material_Patient Card_FR | 1 |
| Subject information and informed consent form (for publication) | L2_ Other subject information material_Patient Info Leaflet_FR | 1b |
| Subject information and informed consent form (for publication) | L2_Other subject information material Patient Card | 2 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Patient Emergency Card | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Abiraterone | n/a |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Prednisolone | NA |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Prednisone | NA |
| Synopsis of the protocol (for publication) | D1_protocol synopsis 2023-506777-36-00_Redacted | f |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis DK 2023-506777-36-00_Redacted | f |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_2023-506777-36-00_ES_Redacted | f |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_FR 2023-506777-36-00_Redacted | f |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_NL_2023-506777-36-00_Redacted | f |
Application history
6 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-01-10 | Denmark | Acceptable 2024-02-19
|
2024-02-19 |
| 2 | SUBSTANTIAL MODIFICATION | SM-3 | 2024-08-02 | Denmark | Acceptable 2024-09-30
|
2024-10-01 |
| 3 | SUBSTANTIAL MODIFICATION | SM-4 | 2024-11-04 | Acceptable | 2024-12-17 | |
| 4 | SUBSTANTIAL MODIFICATION | SM-5 | 2025-03-12 | Denmark | Acceptable 2025-06-04
|
2025-06-04 |
| 5 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-12-19 | Denmark | Acceptable 2025-06-04
|
2025-12-19 |
| 6 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2026-01-26 | Acceptable 2025-06-04
|
2026-01-26 |