Ignite Creation Date:
2025-12-24 @ 5:39 PM
Ignite Modification Date:
2025-12-28 @ 8:00 PM
Study NCT ID:
NCT05999968
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-07-09
First Post:
2023-08-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Abemaciclib Plus Darolutamide in Prostate Cancer That Has Spread After Initial Treatment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011471', 'term': 'Prostatic Neoplasms'}], 'ancestors': [{'id': 'D005834', 'term': 'Genital Neoplasms, Male'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D011469', 'term': 'Prostatic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000590451', 'term': 'abemaciclib'}, {'id': 'C000607739', 'term': 'darolutamide'}, {'id': 'D007987', 'term': 'Gonadotropin-Releasing Hormone'}], 'ancestors': [{'id': 'D010906', 'term': 'Pituitary Hormone-Releasing Hormones'}, {'id': 'D007028', 'term': 'Hypothalamic Hormones'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D009479', 'term': 'Neuropeptides'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D009842', 'term': 'Oligopeptides'}, {'id': 'D009419', 'term': 'Nerve Tissue Proteins'}, {'id': 'D011506', 'term': 'Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2024-01-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'nctId': 'NCT03763604', 'statusForNctId': 'APPROVED_FOR_MARKETING', 'hasExpandedAccess': True}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2026-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-07', 'studyFirstSubmitDate': '2023-08-14', 'studyFirstSubmitQcDate': '2023-08-14', 'lastUpdatePostDateStruct': {'date': '2025-07-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-08-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-02-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration', 'timeFrame': 'Date of first dose to study completion (approximately 32 months)', 'description': 'Administration Number of Participants with One or More SAEs Considered by the Investigator to be Related to Study Drug Administration'}], 'secondaryOutcomes': [{'measure': 'Radiographic Progression-Free Survival (rPFS) Assessed by Investigator rPFS Assessed by Investigator', 'timeFrame': 'Date of first dose to radiographic disease progression or death from any cause (approximately 32 months)', 'description': 'rPFS Assessed by Investigator'}, {'measure': 'Objective Response Rate (ORR): Percentage of Participants with Soft Tissue Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR)', 'timeFrame': 'Date of first dose to radiographic disease progression or death from any cause (approximately 32 months)', 'description': 'ORR: Percentage of Participants with Soft Tissue BOR of CR or PR'}, {'measure': 'Duration of Response (DoR)', 'timeFrame': 'Date of first documented CR or PR to radiographic disease progression or death from any cause (approximately 32 months)', 'description': 'DOR'}, {'measure': 'Time to Prostate Specific Antigen (PSA) Progression', 'timeFrame': 'Date of first dose to the first observation of PSA progression (approximately 32 months)', 'description': 'Time to PSA progression'}, {'measure': 'Prostate Specific Antigen (PSA) Response Rate (PSA-RR): Percentage of Participants with a PSA Decrease of at Least 50% from Baseline', 'timeFrame': 'Date of first dose to confirmed PSA progression (approximately 32 months)', 'description': 'PSA-RR'}, {'measure': 'Pharmacokinetics (PK): Mean Concentrations of Abemaciclib and its Active Metabolite(s)', 'timeFrame': 'Cycle 1 Day 1 until Cycle 2 Day 1 (Cycle = 28 days)', 'description': 'PK: Mean Concentrations of Abemaciclib and its Active Metabolite(s)'}, {'measure': 'Pharmacokinetics (PK): Mean Concentrations of Darolutamide and its Active Metabolite', 'timeFrame': 'Cycle 1 Day 1 until Cycle 2 Day 1 (Cycle = 28 days)', 'description': 'PK: Mean Concentrations of Darolutamide and its Active Metabolite'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Prostatic Neoplasms']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://trials.lilly.com/en-US/trial/418175', 'label': 'Abemaciclib Plus Darolutamide in Prostate Cancer That Has Spread After Initial Treatment'}]}, 'descriptionModule': {'briefSummary': 'The main purpose of this study is to learn more about the safety and tolerability of abemaciclib when given in combination with darolutamide to participants with prostate cancer that has spread after initial treatment. Participation may last up to 32 months.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically confirmed adenocarcinoma of the prostate.\n* Metastatic castration-resistant prostate cancer evidenced by:\n\n * Prostate-specific antigen (PSA) or radiographic progression despite castrate levels of testosterone\n * At least 1 bone metastasis on bone scan and/or 1 soft tissue metastasis on computed tomography/magnetic resonance imaging (CT/MRI)\n* Participants who have not undergone bilateral orchiectomy must continue luteinizing-hormone-releasing hormone (LHRH) agonists/antagonists throughout the study.\n* Have adequate organ function.\n* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1.\n\nExclusion Criteria:\n\n* Prior treatment with cyclin-dependent kinase 4 and 6 (CDK4 and CDK6) inhibitors or darolutamide.\n* Prior systemic therapy for metastatic castration-resistant prostate cancer(mCRPC) with cytotoxic chemotherapy, PARP inhibitors, novel hormonal agents (NHAs) (enzalutamide, apalutamide, and abiraterone), and radiopharmaceuticals.\n* Serious preexisting medical condition(s) that, in the judgment of the investigator, would preclude participation in this study.\n* Clinically significant heart disease as evidenced by myocardial infarction, arterial thrombotic events, severe or unstable angina, or congestive heart failure (New York Heart Association Class III or IV) within 6 months of assignment to treatment.'}, 'identificationModule': {'nctId': 'NCT05999968', 'briefTitle': 'Abemaciclib Plus Darolutamide in Prostate Cancer That Has Spread After Initial Treatment', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eli Lilly and Company'}, 'officialTitle': 'A Phase 1b Study of Abemaciclib Plus Darolutamide in Men With Metastatic Castration-Resistant Prostate Cancer', 'orgStudyIdInfo': {'id': '18714'}, 'secondaryIdInfos': [{'id': 'I3Y-MC-JPEI', 'type': 'OTHER', 'domain': 'Eli Lilly and Company'}, {'id': '2023-503919-15-00', 'type': 'OTHER', 'domain': 'EU Trial Number'}, {'id': 'U1111-1294-1466', 'type': 'REGISTRY', 'domain': 'WHO Universal Trial Number (UTN)'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Abemaciclib + Darolutamide', 'description': 'Abemaciclib plus (+) darolutamide. Participants who have not undergone bilateral orchiectomy are required to continue background androgen deprivation therapy (ADT) with a luteinizing hormone-releasing hormone (LHRH) agonist/antagonist throughout the study.', 'interventionNames': ['Drug: Abemaciclib', 'Drug: Darolutamide', 'Drug: LHRH agonist/antagonist']}], 'interventions': [{'name': 'Abemaciclib', 'type': 'DRUG', 'otherNames': ['LY2835219'], 'description': 'Administered orally.', 'armGroupLabels': ['Abemaciclib + Darolutamide']}, {'name': 'Darolutamide', 'type': 'DRUG', 'description': 'Administered orally.', 'armGroupLabels': ['Abemaciclib + Darolutamide']}, {'name': 'LHRH agonist/antagonist', 'type': 'DRUG', 'description': "Physician's choice. Administered in accordance with the prescribing information.", 'armGroupLabels': ['Abemaciclib + Darolutamide']}]}, 'contactsLocationsModule': {'locations': [{'zip': '72762', 'city': 'Springdale', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Highlands Oncology Group', 'geoPoint': {'lat': 36.18674, 'lon': -94.12881}}, {'zip': '11501', 'city': 'Mineola', 'state': 'New York', 'country': 'United States', 'facility': 'Perlmutter Cancer Center at NYU Langone Hospital - Long Island', 'geoPoint': {'lat': 40.74927, 'lon': -73.64068}}, {'zip': '10016', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Laura and Isaac Perlmutter Cancer Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '72622', 'city': 'Nürtingen', 'state': 'Baden-Wurttemberg', 'country': 'Germany', 'facility': 'Studienpraxis Urologie', 'geoPoint': {'lat': 48.62565, 'lon': 9.34203}}, {'zip': '81675', 'city': 'Munich', 'state': 'Bavaria', 'country': 'Germany', 'facility': 'Klinikum Rechts Der Isar Der Technischen Universität München', 'geoPoint': {'lat': 48.13743, 'lon': 11.57549}}, {'zip': '23538', 'city': 'Lübeck', 'state': 'Schleswig-Holstein', 'country': 'Germany', 'facility': 'Universitätsklinikum Schleswig-Holstein', 'geoPoint': {'lat': 53.86893, 'lon': 10.68729}}, {'zip': '20246', 'city': 'Hamburg', 'country': 'Germany', 'facility': 'Universitaetsklinikum Hamburg-Eppendorf', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}, {'zip': '8907', 'city': "L'Hospitalet de Llobregat", 'state': 'Catalunya [Cataluña]', 'country': 'Spain', 'facility': 'Instituto Catalan de Oncologia - Hospital Duran i Reynals', 'geoPoint': {'lat': 41.35967, 'lon': 2.10028}}, {'zip': '28009', 'city': 'Madrid', 'state': 'Madrid, Comunidad de', 'country': 'Spain', 'facility': 'Hospital General Universitario Gregorio Marañon', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '28034', 'city': 'Madrid', 'state': 'Madrid, Comunidad de', 'country': 'Spain', 'facility': 'Hospital Universitario Ramón y Cajal', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '28041', 'city': 'Madrid', 'state': 'Madrid, Comunidad de', 'country': 'Spain', 'facility': 'Hospital Universitario 12 de Octubre', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '06006', 'city': 'Badajoz', 'country': 'Spain', 'facility': 'Hospital Infanta Cristina', 'geoPoint': {'lat': 38.87789, 'lon': -6.97061}}, {'zip': '41013', 'city': 'Seville', 'country': 'Spain', 'facility': 'Hospital Universitario Virgen Del Rocio', 'geoPoint': {'lat': 37.38283, 'lon': -5.97317}}], 'overallOfficials': [{'name': '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)', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Eli Lilly and Company'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eli Lilly and Company', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Bayer', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}