Clinical trial NCT04408924: Abemaciclib (LY2835219) in Men With Heavily Treated Metastatic Castration-Resistant Prostate Cancer
Official title: CYCLONE 1: A Phase 2 Study of Abemaciclib in Metastatic Castration-Resistant Prostate Cancer Patients Previously Treated With a Novel Hormonal Agent and Taxane-based Chemotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Metastatic Castration-Resistant Prostate Cancer
Keywords: mCRPC
CDK4
CDK6
CDK4/6
CDK4&6 inhibitor
CDK4/6 inhibitor
LY2835219
CYCLONE 1
CYCLONE1
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2020-05-29
Enrollment: 44
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The study will evaluate how safe and effective abemaciclib is when given to participants whose metastatic prostate cancer progresses after they had received several previous treatments.


Eligibility criteria: Inclusion Criteria:

* Participant must have metastatic prostate cancer for which castration (medical or surgical) is no longer effective (castration-resistant).
* 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:

* Participant must not have received more than 3 therapy regimens for metastatic castration-resistant prostate cancer (NOTE: GnRHa, first-generation antiandrogens (flutamide, nilutamide, or bicalutamide), diethylstilbestrol (DES) (or other estrogens), corticosteroids, ketoconazole, and bone loss-prevention will not count as systemic therapy regimens.
* 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.

Primary outcomes:
measure: Percentage of Participants With Confirmed Objective Response (Objective Response Rate [ORR])
timeFrame: From Date of First Dose until Objective Progression (Up To 12.8 Months)
Secondary outcomes:
measure: Radiographic Progression-Free Survival (rPFS)
timeFrame: From Date of First Dose until Objective Progression or Death from Any Cause (Up To 12.8 Months)
measure: Overall Survival (OS)
timeFrame: From Date of First Dose until Date of Death from Any Cause (Up To 28 Months)
measure: Duration of Response (DoR)
timeFrame: CR or PR to Disease Progression or Death Due to Any Cause (Up to 12 Months)
measure: Percentage of Participants Achieving CR, PR or Stable Disease (SD) (Disease Control Rate [DCR])
timeFrame: From Date of First Dose until Measured Progressive Disease or Death Due to Any Cause (Up To 12.8 Months)
measure: Time to Prostate-Specific Antigen (PSA) Progression
timeFrame: From Date of First Dose until Confirmed PSA Progression (Up To 12.8 Months)
measure: Percentage of Participants Who Achieved Prostate-Specific Antigen (PSA) Response (PSA Response Rate)
timeFrame: From Date of First Dose until Confirmed PSA Progression (Up To 12.8 Months)
measure: Time to Symptomatic Progression
timeFrame: From Date of First Dose until Symptomatic Progression (Up to 12.8 Months)
measure: Pharmacokinetics (PK): Maximum Plasma Concentration at Steady State (Cmax,ss) of Abemaciclib
timeFrame: Cycle (C) 1 Day (D) 1: Post dose; C1 D15, C2D1, C2D15, C3D1: Pre dose
measure: PK: Minimum/Trough Concentration at Steady State (Cmin,ss) of Abemaciclib
timeFrame: C1 D1: Post dose; C1 D15, C2D1, C2D15, C3D1: Pre dose
measure: PK: Maximum Plasma Concentration at Steady State (Cmax,ss) of Abemaciclib Metabolites (Total Active Species)
timeFrame: C1 D1: Post dose; C1 D15, C2D1, C2D15, C3D1: Pre dose
measure: PK: Minimum/Trough Concentration at Steady State (Cmin,ss) of Abemaciclib Metabolites (Total Active Species)
timeFrame: C1 D1: Post dose; C1 D15, C2D1, C2D15, C3D1: Pre dose
measure: Percentage of Participants With Expression of Ki-67 Proliferation Marker by Immunohistochemistry (IHC)
timeFrame: Baseline
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: University of Utah - Huntsman Cancer Institute
state: Utah
city: Seattle
country: United States
facility: Seattle Cancer Care Alliance
state: Washington
city: Lyon Cedex 08
country: France
facility: Centre Leon Berard
city: Marseille
country: France
facility: Institut Paoli-Calmettes
city: Paris
country: France
facility: Hopital Europeen Georges Pompidou
city: Toulouse cedex 9
country: France
facility: Institut Claudius Regaud
city: Villejuif Cedex
country: France
facility: Gustave Roussy
city: L'Hospitalet de Llobregat
country: Spain
facility: Institut Catala d'Oncologia
state: Barcelona
city: Sabadell
country: Spain
facility: Corporacion Sanitaria Parc Tauli
state: Barcelona
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Maranon
city: Madrid
country: Spain
facility: Hospital Universitario Ramon y Cajal
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
Study officials:
affiliation: Eli Lilly and Company
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
References: