Abemaciclib (LY2835219) in Men With Heavily Treated Metastatic Castration-Resistant Prostate Cancer

NCT04408924 | Completed Phase 2 Results FDA Drug

• 3 other identifiers: 17583I3Y-MC-JPCY2020-000290-24
• Study Type: interventional
• Target: 44
• Locations: 3 countries
• Sites: 14

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.

Conditions

Metastatic Castration-Resistant Prostate Cancer

Keywords

mCRPC; CDK4; CDK6; CDK4/6; CDK4&6 inhibitor; CDK4/6 inhibitor; LY2835219; CYCLONE 1; CYCLONE1

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Confirmed Objective Response (Objective Response Rate [ORR])

  ORR is defined as the percentage of participants with a confirmed complete response (CR) or confirmed partial response (PR) in soft tissue per response evaluation criteria in solid tumors (RECIST) version 1.1 and do not have concurrent bone progression per Prostate Cancer Clinical Trials Working Group 3 (PCWG3), as assessed by the investigator. ORR = (participants with confirmed CR and no bone progression) + (participants with confirmed PR and no bone progression) x 100 / all treated participants.

  From Date of First Dose until Objective Progression (Up To 12.8 Months)

Secondary Outcomes (12)

• Radiographic Progression-Free Survival (rPFS)

  From Date of First Dose until Objective Progression or Death from Any Cause (Up To 12.8 Months)

• Overall Survival (OS)

  From Date of First Dose until Date of Death from Any Cause (Up To 28 Months)

• Duration of Response (DoR)

  CR or PR to Disease Progression or Death Due to Any Cause (Up to 12 Months)

• Percentage of Participants Achieving CR, PR or Stable Disease (SD) (Disease Control Rate [DCR])

  From Date of First Dose until Measured Progressive Disease or Death Due to Any Cause (Up To 12.8 Months)

• Time to Prostate-Specific Antigen (PSA) Progression

  From Date of First Dose until Confirmed PSA Progression (Up To 12.8 Months)

Study Arms (1)

200 milligram (mg) Abemaciclib Twice Daily

EXPERIMENTAL

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.

Drug: Abemaciclib

Interventions

Abemaciclib DRUG

Administered orally

Also known as: LY2835219

200 milligram (mg) Abemaciclib Twice Daily

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (14)

University of Utah - Huntsman Cancer Institute

Salt Lake City, Utah, 84112, United States

Location

Seattle Cancer Care Alliance

Seattle, Washington, 98109, United States

Location

Centre Leon Berard

Lyon, 69373, France

Location

Institut Paoli-Calmettes

Marseille, 13273, France

Location

Hopital Europeen Georges Pompidou

Paris, 75015, France

Location

Institut Claudius Regaud

Toulouse, 31059, France

Location

Gustave Roussy

Villejuif, 94805, France

Location

Institut Catala d'Oncologia

L'Hospitalet de Llobregat, Barcelona, 08907, Spain

Location

Corporacion Sanitaria Parc Tauli

Sabadell, Barcelona, 08208, Spain

Location

Hospital de la Santa Creu i Sant Pau

Barcelona, 08025, Spain

Location

Hospital Universitari Vall d'Hebron

Barcelona, 08035, Spain

Location

Hospital General Universitario Gregorio Maranon

Madrid, 28007, Spain

Location

Hospital Universitario Ramon y Cajal

Madrid, 28034, Spain

Location

Hospital Universitario 12 de Octubre

Madrid, 28041, Spain

Location

Related Links

• Abemaciclib (LY2835219) in Men With Heavily Treated Metastatic Castration-Resistant Prostate Cancer (CYCLONE 1)

MeSH Terms

Interventions

abemaciclib

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Eli Lilly and Company

ClinicalTrials.gov@lilly.com

800-545-5979

Study Officials

• 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

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR
• Expanded Access: Yes

Study Record Dates

• First Submitted: May 28, 2020
• First Posted: May 29, 2020
• Study Start: January 20, 2021
• Primary Completion: April 27, 2022
• Study Completion: June 2, 2023
• Last Updated: June 25, 2024
• Results First Posted: May 24, 2023

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
• Access Criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.

Locations

FR (5); ES (7); US (2)