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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06551324




Registration number
NCT06551324
Ethics application status
Date submitted
25/07/2024
Date registered
13/08/2024

Titles & IDs
Public title
A Study to Learn About the Investigational Medicine Called PF-06821497 (Mevrometostat) in Men With mCRPC Who Were Previously Treated With Abiraterone Acetate for Prostate Cancer (MEVPRO-1).
Scientific title
A PHASE 3, RANDOMIZED, OPEN-LABEL STUDY OF PF-06821497 (MEVROMETOSTAT) IN COMBINATION WITH ENZALUTAMIDE COMPARED WITH ENZALUTAMIDE OR DOCETAXEL IN PARTICIPANTS WITH METASTATIC CASTRATION RESISTANT PROSTATE CANCER PREVIOUSLY TREATED WITH ABIRATERONE ACETATE (MEVPRO-1)
Secondary ID [1] 0 0
2024-511650-50-00
Secondary ID [2] 0 0
C2321014
Universal Trial Number (UTN)
Trial acronym
MEVPRO-1
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Metastatic Castrate Resistant Prostate Cancer (mCRPC) 0 0
Condition category
Condition code
Cancer 0 0 0 0
Prostate

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - PF-06821497
Treatment: Drugs - Docetaxel
Treatment: Drugs - Enzalutamide

Experimental: Arm A - Investigational Arm A: PF-06821497 875 mg twice daily (BID) + enzalutamide 160 mg every day (QD)

Active comparator: Arm B - Comparator Arm B: Physician's choice of enzalutamide 160 mg QD or docetaxel 75 mg/m2 intravenous (IV) every 21 days


Treatment: Drugs: PF-06821497
875 mg BID (2 times a day)

Treatment: Drugs: Docetaxel
75 mg/m2 IV (every 21 days)

Treatment: Drugs: Enzalutamide
160 mg QD
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Radiographic Progression Free Survival (rPFS) assessed by blinded independent central review (BICR) per RECIST v1.1 and Prostate Cancer Clinical Trials Working Group 3 (PCWG3)
Timepoint [1] 0 0
Randomization up to approximately 2 years.
Secondary outcome [1] 0 0
Overall survival (OS)
Timepoint [1] 0 0
Randomization up to approximately 4.5 years.
Secondary outcome [2] 0 0
Objective Response (ORR)
Timepoint [2] 0 0
Randomization up to approximately 2 years.
Secondary outcome [3] 0 0
Duration of Response (DoR) in measurable soft tissue disease
Timepoint [3] 0 0
Randomization up to approximately 2 years.
Secondary outcome [4] 0 0
Time to prostate specific antigen (PSA) progression.
Timepoint [4] 0 0
Randomization up to approximately 2 years.
Secondary outcome [5] 0 0
Time to initiation of antineoplastic therapy.
Timepoint [5] 0 0
Randomization up to approximately 4.5 years.
Secondary outcome [6] 0 0
Prostate Specific Antigen Response
Timepoint [6] 0 0
Randomization up to approximately 2 years.
Secondary outcome [7] 0 0
Incidence of Adverse Events
Timepoint [7] 0 0
Randomization up to approximately 4.5 years
Secondary outcome [8] 0 0
Time to first symptomatic skeletal event
Timepoint [8] 0 0
Randomization up to approximately 2 years.
Secondary outcome [9] 0 0
Change from baseline in patient reported pain symptoms per Brief Pain Inventory-Short Form (BPI-SF)
Timepoint [9] 0 0
Randomization up to approximately 4.5 years
Secondary outcome [10] 0 0
Change from baseline in health-related quality of life (HRQoL) per Functional Assessment of Cancer Therapy - Prostate (FACT-P)
Timepoint [10] 0 0
Randomization to approximately 4.5 years
Secondary outcome [11] 0 0
Change from baseline in social/family well-being per Functional Assessment of Cancer Therapy - Prostate (FACT-P)
Timepoint [11] 0 0
Randomization up to approximately 4.5 years
Secondary outcome [12] 0 0
Change from baseline in emotional well-being per Functional Assessment of Cancer Therapy - Prostate (FACT-P)
Timepoint [12] 0 0
Randomization up to approximately 4.5 years
Secondary outcome [13] 0 0
Change from baseline in functioning well-being per Functional Assessment of Cancer Therapy - Prostate (FACT-P)
Timepoint [13] 0 0
Randomization up to approximately 4.5 years
Secondary outcome [14] 0 0
Change from baseline in physical well-being per Functional Assessment of Cancer Therapy - Prostate (FACT-P)
Timepoint [14] 0 0
Randomization to approximately 4.5 years
Secondary outcome [15] 0 0
Change from baseline in symptoms per Functional Assessment of Cancer Therapy - Prostate (FACT-P)
Timepoint [15] 0 0
Randomization up to approximately 4.5 years
Secondary outcome [16] 0 0
Change from baseline in patient reported health status per European Quality of Life 5-Dimension 5 Level (EQ-5D-5L)
Timepoint [16] 0 0
Randomizaton up to approximately 4.5 years
Secondary outcome [17] 0 0
Symptomatic toxicity as measured by items from the Patient-Reported Outcome CTCAE (PRO-CTCAE)
Timepoint [17] 0 0
Randomization up to approximately 4.5 years
Secondary outcome [18] 0 0
Overall side effect burden as measured by the FACT- GP5
Timepoint [18] 0 0
Randomization to approximately 4.5 years
Secondary outcome [19] 0 0
Time to confirmatory deterioration in patient-reported pain symptoms per BPI-SF Item 3 "worst pain in 24 hours"
Timepoint [19] 0 0
Randomization up to approximately 4.5 years
Secondary outcome [20] 0 0
Time to definitive deterioration in patient-reported health related quality of life (HRQoL) per FACT-P
Timepoint [20] 0 0
Randomization up to approximately 4.5 years
Secondary outcome [21] 0 0
Time to definitive deterioration in patient-reported physical well-being per FACT-P
Timepoint [21] 0 0
Randomization up to approximately 4.5 years
Secondary outcome [22] 0 0
To evaluate the PK of PF-06821497 when dosed with enzalutamide
Timepoint [22] 0 0
Cycle 1 (each cycle is 28 days), Day 1 to last PK draw at the end of Cycle 6, Day 1.
Secondary outcome [23] 0 0
To assess circulating tumor DNA (ctDNA) at baseline and on treatment to evaluate tumor burden.
Timepoint [23] 0 0
Baseline up to approximately 2 years.

Eligibility
Key inclusion criteria
* Histologically or cytologically confirmed adenocarcinoma of the prostate without small cell features.
* Metastatic disease in bone documented on bone scan, or in soft tissue documented on CT/MRI scan.
* Progressive disease in the setting of surgical or medical castration.
* Eastern Cooperate Oncology Group (ECOG) performance status 0 - 2, with life expectancy of at least 6 months as assessed by the investigator.
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
* Any medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may make the participant. inappropriate for the study.
* Clinically significant cardiovascular disease.
* Known or suspected brain metastasis or active leptomeningeal disease or clinically significant history of seizure.
* Prior treatment for prostate cancer at any stage with any cytotoxic chemotherapy, radioligand therapy, androgen receptor signaling inhibitors (ARSi) including enzalutamide, apalutamide, darolutamide, poly ADP-ribose polymerase (PARP) monotherapy or other systemic anti-cancer treatment.
* Inadequate organ function.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
1/10/2024
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
29/10/2028
Actual
Sample size
Target
600
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Monash Health - Clayton
Recruitment hospital [2] 0 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment postcode(s) [1] 0 0
3168 - Clayton
Recruitment postcode(s) [2] 0 0
3000 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Illinois
Country [2] 0 0
United States of America
State/province [2] 0 0
Pennsylvania
Country [3] 0 0
United States of America
State/province [3] 0 0
Texas
Country [4] 0 0
China
State/province [4] 0 0
Jiangsu
Country [5] 0 0
China
State/province [5] 0 0
Sichuan
Country [6] 0 0
China
State/province [6] 0 0
Zhejiang
Country [7] 0 0
Japan
State/province [7] 0 0
Chiba
Country [8] 0 0
Japan
State/province [8] 0 0
Ehime
Country [9] 0 0
Japan
State/province [9] 0 0
Hokkaido
Country [10] 0 0
Japan
State/province [10] 0 0
Hyogo
Country [11] 0 0
Japan
State/province [11] 0 0
Kanagawa
Country [12] 0 0
Japan
State/province [12] 0 0
Osaka
Country [13] 0 0
Japan
State/province [13] 0 0
Fukuoka
Country [14] 0 0
Japan
State/province [14] 0 0
Kumamoto
Country [15] 0 0
Japan
State/province [15] 0 0
Yamagata

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Pfizer
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Pfizer CT.gov Call Center
Address 0 0
Pfizer
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Pfizer CT.gov Call Center
Address 0 0
Country 0 0
Phone 0 0
1-800-718-1021
Fax 0 0
Email 0 0
ClinicalTrials.gov_Inquiries@pfizer.com
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06551324