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Dalpiciclib Isethionate Tablets Combined With Abiraterone Acetate Tablets (I) and Prednisone Tablets (AA-P) Versus Placebo Combined With AA-P in Treatment of High-volume, Metastatic, Hormone-sensitive Prostate Cancer (mHSPC)

Primary Purpose

High-volume, Metastatic, Hormone-sensitive Prostate Cancer (mHSPC)

Status
Not yet recruiting
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
dalpiciclib isethionate tablets; abiraterone acetate tablets; prednisone tablets
placebo; abiraterone acetate tablets; prednisone tablets
Sponsored by
Jiangsu HengRui Medicine Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for High-volume, Metastatic, Hormone-sensitive Prostate Cancer (mHSPC)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria: Age of ≥ 18 years old,male ECOG PS score of 0 or 1; Prostate adenocarcinoma confirmed by histological。 ADT no more than 3 months prior to randomization (when docetaxel is not used) with no radiographic or PSA progression Receiving or maintaining androgen deprivation therapy (ADT) during the planned study period, i.e. continuous treatment with luteinizing hormone-releasing hormone analogues (LHRHA) (drug castration) or prior bilateral orchiectomy (surgical castration) Voluntarily participate in this clinical trial, understand the study procedure and have signed informed consent Exclusion Criteria: Previous ADT, chemotherapy, surgery, external radiation exposure, brachytherapy, radiopharmaceuticals, or experimental topical treatments (eg, radiofrequency ablation, cryoponic, high-energy focused ultrasound) for prostate cancer Previous use of CDK4/6 inhibitors (such as piperaciclib, rebocillib and abeceptil), second-generation androgen receptor antagonists (such as enzalutamide, apatamide, darotamide, revilumide and proclomide, etc.), ketoconazole, abiraterone acetate or other investigational drugs that inhibit androgen synthesis (such as TAK-700), other anti-tumor biological therapy, targeted therapy or tumor immunotherapy Confirmed by imaging, there are brain tumor foci History of severe lung disease such as interstitial pneumonia Plan to receive any other antitumor therapy during this trial Inability to swallow, chronic diarrhea and intestinal obstruction, or other factors that affect drug taking and absorption

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    dalpiciclib+ abiraterone+ prednisone

    placebo+abirarerone+prenisone

    Arm Description

    Outcomes

    Primary Outcome Measures

    Adverse event (AE) incidence

    Secondary Outcome Measures

    PK: Steady-state trough concentrations of Dalsili and Abiraterone (Cmin, ss)
    rPFS
    Time from randomisation to radiologically confirmed progressive disease or death due to any cause
    PSA response rate
    In patients who had not started androgen deprivation prior to randomization, the proportion of patients whose PSA levels were ≥ 90% lower than baseline by the end of the study treatment week
    ORR
    Objective response rate+ The proportion of participants evaluated according to RECIST v1.1 and PCWG3 criteria that achieved predetermined tumor volume reduction and maintained the minimum duration was the sum of the proportion of complete and partial responses
    Time to PSA progression
    Time from randomisation to the first time of PSA progression

    Full Information

    First Posted
    October 13, 2023
    Last Updated
    October 20, 2023
    Sponsor
    Jiangsu HengRui Medicine Co., Ltd.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06099990
    Brief Title
    Dalpiciclib Isethionate Tablets Combined With Abiraterone Acetate Tablets (I) and Prednisone Tablets (AA-P) Versus Placebo Combined With AA-P in Treatment of High-volume, Metastatic, Hormone-sensitive Prostate Cancer (mHSPC)
    Official Title
    A Multicenter, Randomized, Double-blind Phase Ib/III Clinical Study of Dalpiciclib Isethionate Tablets Combined With Abiraterone Acetate Tablets (I) and Prednisone Tablets (AA-P) Versus Placebo Combined With AA-P in Treatment of High-volume, Metastatic, Hormone-sensitive Prostate Cancer (mHSPC).
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 2023 (Anticipated)
    Primary Completion Date
    December 2028 (Anticipated)
    Study Completion Date
    December 2028 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Jiangsu HengRui Medicine Co., Ltd.

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    This study was to evaluate the safety and efficacy of dalcilide tablets in combination with AA-P in the treatment of subjects with high tumor burden mHSPC and to determine the second stage starting dose and progression-free survival(rPFS) based on BICR assessment

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    High-volume, Metastatic, Hormone-sensitive Prostate Cancer (mHSPC)

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    660 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    dalpiciclib+ abiraterone+ prednisone
    Arm Type
    Experimental
    Arm Title
    placebo+abirarerone+prenisone
    Arm Type
    Placebo Comparator
    Intervention Type
    Drug
    Intervention Name(s)
    dalpiciclib isethionate tablets; abiraterone acetate tablets; prednisone tablets
    Intervention Description
    dalpiciclib+ abiraterone+ prednisone
    Intervention Type
    Drug
    Intervention Name(s)
    placebo; abiraterone acetate tablets; prednisone tablets
    Intervention Description
    placebo+abirarerone+prenisone
    Primary Outcome Measure Information:
    Title
    Adverse event (AE) incidence
    Time Frame
    approximately 63 months
    Secondary Outcome Measure Information:
    Title
    PK: Steady-state trough concentrations of Dalsili and Abiraterone (Cmin, ss)
    Time Frame
    approximately 6 months
    Title
    rPFS
    Description
    Time from randomisation to radiologically confirmed progressive disease or death due to any cause
    Time Frame
    approximately 63 months
    Title
    PSA response rate
    Description
    In patients who had not started androgen deprivation prior to randomization, the proportion of patients whose PSA levels were ≥ 90% lower than baseline by the end of the study treatment week
    Time Frame
    approximately 63 months
    Title
    ORR
    Description
    Objective response rate+ The proportion of participants evaluated according to RECIST v1.1 and PCWG3 criteria that achieved predetermined tumor volume reduction and maintained the minimum duration was the sum of the proportion of complete and partial responses
    Time Frame
    approximately 63 months
    Title
    Time to PSA progression
    Description
    Time from randomisation to the first time of PSA progression
    Time Frame
    approximately 63 months

    10. Eligibility

    Sex
    Male
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Age of ≥ 18 years old,male ECOG PS score of 0 or 1; Prostate adenocarcinoma confirmed by histological。 ADT no more than 3 months prior to randomization (when docetaxel is not used) with no radiographic or PSA progression Receiving or maintaining androgen deprivation therapy (ADT) during the planned study period, i.e. continuous treatment with luteinizing hormone-releasing hormone analogues (LHRHA) (drug castration) or prior bilateral orchiectomy (surgical castration) Voluntarily participate in this clinical trial, understand the study procedure and have signed informed consent Exclusion Criteria: Previous ADT, chemotherapy, surgery, external radiation exposure, brachytherapy, radiopharmaceuticals, or experimental topical treatments (eg, radiofrequency ablation, cryoponic, high-energy focused ultrasound) for prostate cancer Previous use of CDK4/6 inhibitors (such as piperaciclib, rebocillib and abeceptil), second-generation androgen receptor antagonists (such as enzalutamide, apatamide, darotamide, revilumide and proclomide, etc.), ketoconazole, abiraterone acetate or other investigational drugs that inhibit androgen synthesis (such as TAK-700), other anti-tumor biological therapy, targeted therapy or tumor immunotherapy Confirmed by imaging, there are brain tumor foci History of severe lung disease such as interstitial pneumonia Plan to receive any other antitumor therapy during this trial Inability to swallow, chronic diarrhea and intestinal obstruction, or other factors that affect drug taking and absorption
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Feng Liu
    Phone
    +86-18875033874
    Email
    feng.liu.fl10@hengrui.com

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

    Learn more about this trial

    Dalpiciclib Isethionate Tablets Combined With Abiraterone Acetate Tablets (I) and Prednisone Tablets (AA-P) Versus Placebo Combined With AA-P in Treatment of High-volume, Metastatic, Hormone-sensitive Prostate Cancer (mHSPC)

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