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| ID | Type | Description | Link |
|---|---|---|---|
| I3Y-MC-JPEI | Other Identifier | Eli Lilly and Company | |
| 2023-503919-15-00 | Other Identifier | EU Trial Number | |
| U1111-1294-1466 | Registry Identifier | WHO Universal Trial Number (UTN) |
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The study was terminated early as related study I3Y-MC-JPCM (NCT03706365) did not meet its primary endpoint.
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| Name | Class |
|---|---|
| Bayer | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Abemaciclib + Darolutamide | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Abemaciclib | Drug | Administered orally. |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration | Administration Number of Participants with One or More SAEs Considered by the Investigator to be Related to Study Drug Administration | Date of first dose to study completion (approximately 32 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Radiographic Progression-Free Survival (rPFS) Assessed by Investigator rPFS Assessed by Investigator | rPFS Assessed by Investigator | Date of first dose to radiographic disease progression or death from any cause (approximately 32 months) |
| Objective Response Rate (ORR): Percentage of Participants with Soft Tissue Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR) |
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Inclusion Criteria:
Histologically confirmed adenocarcinoma of the prostate.
Metastatic castration-resistant prostate cancer evidenced by:
Participants who have not undergone bilateral orchiectomy must continue luteinizing-hormone-releasing hormone (LHRH) agonists/antagonists throughout the study.
Have adequate organ function.
Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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) | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Highlands Oncology Group | Springdale | Arkansas | 72762 | United States | ||
| Perlmutter Cancer Center at NYU Langone Hospital - Long Island |
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| Label | URL |
|---|---|
| Abemaciclib Plus Darolutamide in Prostate Cancer That Has Spread After Initial Treatment | View source |
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| Darolutamide | Drug | Administered orally. |
|
| LHRH agonist/antagonist | Drug | Physician's choice. Administered in accordance with the prescribing information. |
|
ORR: Percentage of Participants with Soft Tissue BOR of CR or PR |
| Date of first dose to radiographic disease progression or death from any cause (approximately 32 months) |
| Duration of Response (DoR) | DOR | Date of first documented CR or PR to radiographic disease progression or death from any cause (approximately 32 months) |
| Time to Prostate Specific Antigen (PSA) Progression | Time to PSA progression | Date of first dose to the first observation of PSA progression (approximately 32 months) |
| Prostate Specific Antigen (PSA) Response Rate (PSA-RR): Percentage of Participants with a PSA Decrease of at Least 50% from Baseline | PSA-RR | Date of first dose to confirmed PSA progression (approximately 32 months) |
| Pharmacokinetics (PK): Mean Concentrations of Abemaciclib and its Active Metabolite(s) | PK: Mean Concentrations of Abemaciclib and its Active Metabolite(s) | Cycle 1 Day 1 until Cycle 2 Day 1 (Cycle = 28 days) |
| Pharmacokinetics (PK): Mean Concentrations of Darolutamide and its Active Metabolite | PK: Mean Concentrations of Darolutamide and its Active Metabolite | Cycle 1 Day 1 until Cycle 2 Day 1 (Cycle = 28 days) |
| Mineola |
| New York |
| 11501 |
| United States |
| Laura and Isaac Perlmutter Cancer Center | New York | New York | 10016 | United States |
| Studienpraxis Urologie | Nürtingen | Baden-Wurttemberg | 72622 | Germany |
| Klinikum Rechts Der Isar Der Technischen Universität München | Munich | Bavaria | 81675 | Germany |
| Universitätsklinikum Schleswig-Holstein | Lübeck | Schleswig-Holstein | 23538 | Germany |
| Universitaetsklinikum Hamburg-Eppendorf | Hamburg | 20246 | Germany |
| Instituto Catalan de Oncologia - Hospital Duran i Reynals | L'Hospitalet de Llobregat | Catalunya [Cataluña] | 8907 | Spain |
| Hospital General Universitario Gregorio Marañon | Madrid | Madrid, Comunidad de | 28009 | Spain |
| Hospital Universitario Ramón y Cajal | Madrid | Madrid, Comunidad de | 28034 | Spain |
| Hospital Universitario 12 de Octubre | Madrid | Madrid, Comunidad de | 28041 | Spain |
| Hospital Infanta Cristina | Badajoz | 06006 | Spain |
| Hospital Universitario Virgen Del Rocio | Seville | 41013 | Spain |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| C000590451 | abemaciclib |
| C000607739 | darolutamide |
| D007987 | Gonadotropin-Releasing Hormone |
| ID | Term |
|---|---|
| D010906 | Pituitary Hormone-Releasing Hormones |
| D007028 | Hypothalamic Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D009479 | Neuropeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D009842 | Oligopeptides |
| D009419 | Nerve Tissue Proteins |
| D011506 | Proteins |
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