Abemaciclib (LY2835219) in Men With Heavily Treated Metastatic Castration-Resistant Prostate Cancer
NCT ID: NCT04408924
Last Updated: 2024-06-25
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
44 participants
INTERVENTIONAL
2021-01-20
2023-06-02
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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200 milligram (mg) Abemaciclib Twice Daily
Participants received 200 mg abemaciclib administered orally twice daily on a continuous dosing schedule (28-day cycle) until symptomatic and/or radiographic progression, unacceptable toxicity, or until another discontinuation criterion is met.
Abemaciclib
Administered orally
Interventions
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Abemaciclib
Administered orally
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Participant must have disease spread to soft tissue that is measurable.
* Participant must have documented evidence of progressive disease by PSA test or imaging.
* Participant must have previously received at least one of the following treatment: abiraterone acetate, apalutamide, darolutamide or enzalutamide.
* Participant must have previously received chemotherapy with docetaxel and cabazitaxel.
* Participant must be willing and amenable to undergo a biopsy of tumor tissue (or able to provide adequate archived tumor tissue sample) and to provide blood for research.
* Participant must have good physical functioning ability and adequate organ function.
Exclusion Criteria
* Participants must not have previously received abemaciclib or any cyclin-dependent kinase (CDK)4 and/or CDK6 inhibitors.
* Participants must not have serious and/or uncontrolled preexisting medical condition(s) including but not limited to severe renal impairment, severe hepatic impairment, interstitial lung disease (ILD)/pneumonitis, severe dyspnea at rest or requiring oxygen therapy or other serious preexisting medical condition(s) that, in the judgment of the investigator, would preclude participation in this study.
* Participants must not have, or suspected to have, brain metastasis.
* Participants must not have untreated spinal cord compression, evidence of spinal metastases with risk of spinal compression or structurally unstable bone lesions suggesting impending fracture.
18 Years
MALE
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Responsible Party
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Principal Investigators
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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
Eli Lilly and Company
Locations
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University of Utah - Huntsman Cancer Institute
Salt Lake City, Utah, United States
Seattle Cancer Care Alliance
Seattle, Washington, United States
Centre Leon Berard
Lyon, , France
Institut Paoli-Calmettes
Marseille, , France
Hopital Europeen Georges Pompidou
Paris, , France
Institut Claudius Regaud
Toulouse, , France
Gustave Roussy
Villejuif, , France
Institut Catala d'Oncologia
L'Hospitalet de Llobregat, Barcelona, Spain
Corporacion Sanitaria Parc Tauli
Sabadell, Barcelona, Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, , Spain
Hospital Universitari Vall d'Hebron
Barcelona, , Spain
Hospital General Universitario Gregorio Maranon
Madrid, , Spain
Hospital Universitario Ramon y Cajal
Madrid, , Spain
Hospital Universitario 12 de Octubre
Madrid, , Spain
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Abemaciclib (LY2835219) in Men With Heavily Treated Metastatic Castration-Resistant Prostate Cancer (CYCLONE 1)
Other Identifiers
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I3Y-MC-JPCY
Identifier Type: OTHER
Identifier Source: secondary_id
2020-000290-24
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
17583
Identifier Type: -
Identifier Source: org_study_id
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