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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT06629779
Registration number
NCT06629779
Ethics application status
Date submitted
10/09/2024
Date registered
8/10/2024
Date last updated
8/07/2025
Titles & IDs
Public title
A Study to Learn How PF-06821497 (Mevrometostat) Works in Men With Metastatic Castration-resistant Prostate Cancer.
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Scientific title
A PHASE 3, RANDOMIZED, DOUBLE BLIND, PLACEBO CONTROLLED STUDY OF PF-06821497 (MEVROMETOSTAT) WITH ENZALUTAMIDE IN METASTATIC CASTRATION RESISTANT PROSTATE CANCER (MEVPRO-2)
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Secondary ID [1]
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2024-511652-40-00
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Secondary ID [2]
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C2321003
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Metastatic Castration-Resistant Prostate Cancer
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Condition category
Condition code
Cancer
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Prostate
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - PF-06821497
Treatment: Drugs - Placebo
Treatment: Drugs - Enzalutamide
Experimental: Arm A - Participants will receive PF-06821497 (875 mg) BID (twice daily) + enzalutamide 160 mg QD (once daily)
Active comparator: Arm B - Participants will receive Placebo BID (twice daily) + enzalutamide 160 mg QD (once daily)
Treatment: Drugs: PF-06821497
Oral continuous
Treatment: Drugs: Placebo
Oral continuous
Treatment: Drugs: Enzalutamide
Oral continuous
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Radiographic Progression Free Survival (rPFS)
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Assessment method [1]
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rPFS is defined as the time from the date of randomization to first objective evidence of radiographic progression as assessed in soft tissue per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 or in bone per Prostate Cancer Clinical Trials Working Group 3 (PCWG3) guidelines by BICR, or death, whichever occurs first.
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Timepoint [1]
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Randomization up to approximately 3 years
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Secondary outcome [1]
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Overall survival (OS)
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Assessment method [1]
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OS is defined as the time from the date of randomization to the date of death due to any cause.
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Timepoint [1]
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Randomization up to approximately 5 years
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Secondary outcome [2]
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To demonstrate that PF-06821497 in combination with enzalutamide is superior to placebo in combination with enzalutamide in prolonging TTPP
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Assessment method [2]
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TTPP (alpha protected): assessed using time to first =2-point increase from baseline score on BPI-SF Item 3 (Worst Pain) observed at 2 consecutive visits or the initiation of short- or long-acting opioid use for pain
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Timepoint [2]
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Randomization up to approximately 3 years
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Secondary outcome [3]
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Duration of Response (DoR) in measurable soft tissue disease
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Assessment method [3]
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The DoR is defined as the time from the first objective evidence of soft tissue response (CR or PR, whichever is earlier) to radiographic progression or death due to any cause whichever occurs first.
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Timepoint [3]
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Randomization up to approximately 3 years.
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Secondary outcome [4]
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Time to prostate specific antigen (PSA) progression.
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Assessment method [4]
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Time from the date of randomization to the date of the first PSA progression. PSA progression is defined as a =25% increase in PSA with an absolute increase of =2 ng/mL above the nadir (or baseline for participants with no PSA decline), confirmed by a second consecutive PSA value at least 21 days later.
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Timepoint [4]
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Randomization up to approximately 3 years
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Secondary outcome [5]
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Prostate Specific Antigen Response
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Assessment method [5]
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Proportion of participants with PSA response =50% in participants with detectable PSA values at baseline.
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Timepoint [5]
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Randomization up to approximately 3 years.
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Secondary outcome [6]
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Time to initiation of antineoplastic therapy.
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Assessment method [6]
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Time from randomization to first use of new antineoplastic therapy.
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Timepoint [6]
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Randomization up to approximately 3 years.
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Secondary outcome [7]
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Time to initiation of cytotoxic chemotherapy.
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Assessment method [7]
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Time from randomization to first use of new cytotoxic chemotherapy.
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Timepoint [7]
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Randomization up to approximately 3 years
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Secondary outcome [8]
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Time to first symptomatic skeletal event
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Assessment method [8]
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Time from randomization to first symptomatic skeletal event (symptomatic bone fractures, spinal cord compression, surgery or radiation to the bone whichever is first).
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Timepoint [8]
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Randomization up to approximately 3 years.
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Secondary outcome [9]
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Progression free survival on next line of therapy
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Assessment method [9]
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the time from the date of randomization to the first occurrence of investigator-determined disease progression (PSA progression, progression on imaging, or clinical progression) or death due to any cause, whichever occurs first, while the participant was receiving first subsequent therapy for prostate cancer.
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Timepoint [9]
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Randomization up to approximately 3 years
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Secondary outcome [10]
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Incidence of Adverse Events
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Assessment method [10]
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Type, incidence, severity \[as graded by National Cancer Institute (NCI) common terminology criteria for adverse events (CTCAE) v5.0\], seriousness and relationship to study medications of AEs.
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Timepoint [10]
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Randomization up to approximately 5 years
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Secondary outcome [11]
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To assess circulating tumor DNA (ctDNA) at baseline and on treatment to evaluate tumor burden.
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Assessment method [11]
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Evaluation of ctDNA burden at baseline and on study.
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Timepoint [11]
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Baseline up to approximately 3 years.
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Secondary outcome [12]
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To evaluate the PK of PF-06821497 when dosed with enzalutamide
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Assessment method [12]
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PK characterized by pre-dose trough and post-dose plasma concentrations of PF-06821497 at selected visits
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Timepoint [12]
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Cycle 1 Day 15 to last PK draw at Cycle 6 Day 1 (cycle length is 28 days)
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Secondary outcome [13]
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Change from baseline in patient reported pain symptoms per Brief Pain Inventory-Short Form (BPI-SF)
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Assessment method [13]
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Analysis of Brief Pain Inventory-Short Form (BPI-SF) will be based on the pain severity score (mean of individual BPI-SF items 3, 4, 5 and 6), the pain interference score (mean of items 9A-9G), and the single BPI-SF Item 3 which asks the patient to rate pain at its worst in the last 24 hours.
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Timepoint [13]
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Randomization up to approximately 5 years
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Secondary outcome [14]
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Change from baseline in BPI-SF Item 3 (Worst Pain) at Cycle 7 Day 1 (Week 25)
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Assessment method [14]
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Analysis of Brief Pain Inventory-Short Form (BPI-SF) will be based on the pain severity score (mean of individual BPI-SF items 3, 4, 5 and 6), the pain interference score (mean of items 9A-9G), and the single BPI-SF Item 3 which asks the patient to rate pain at its worst in the last 24 hours.
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Timepoint [14]
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Randomization up to Week 25
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Secondary outcome [15]
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Change from baseline in health-related quality of life (HRQoL) per Functional Assessment of Cancer Therapy - Prostate (FACT-P)
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Assessment method [15]
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Change from baseline in HRQoL (FACT-P total score) will be presented. The FACT-P total score will be calculated based on the participant responses to the 39 items in the FACT-P questionnaire. Each item is rated on a 0 to 4 Likert-type scale and then combined to produce the FACT-P total score (0-156), with higher scores representing better health-related quality of life.
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Timepoint [15]
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Randomization up to approximately 5 years
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Secondary outcome [16]
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Change from baseline in patient reported health status per European Quality of Life 5-Dimension 5 Level (EQ-5D-5L)
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Assessment method [16]
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Participants will self-rate their current state of mobility, self-care, usual activities, pain/discomfort, and anxiety/depression by choosing 1 of 5 possible responses that record the level of severity (no problems, slight problems, moderate problems, severe problems, or extreme problems) within each dimension. The questionnaire also includes a visual analog scale to self-rate general health state on a scale from "the worst health you can imagine" to "the best health you can imagine."
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Timepoint [16]
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Randomization up to approximately 5 years
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Secondary outcome [17]
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Symptomatic toxicity as measured by items from the Patient-Reported Outcome CTCAE (PRO-CTCAE)
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Assessment method [17]
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Each selected PRO-CTCAE items will be assessed related to one or more attributes that include counts for the frequency, severity, and/or interference with usual or daily activities.
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Timepoint [17]
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Randomization up to approximately 5 years
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Secondary outcome [18]
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Time to definitive deterioration in patient-reported health related quality of life (HRQoL) per FACT-P
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Assessment method [18]
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Defined as the time from randomization to onset of definitive deterioration in FACT-P total score, which is defined as \>10 point decrease from baseline and no subsequent observations with a \<10 point decrease from baseline FACT-P total score
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Timepoint [18]
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Randomization up to approximately 5 years
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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 medical or surgical castration.
* ECOG performance status 0 or 1, with a life expectancy of =12 months as assessed by the investigator.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Males
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Can healthy volunteers participate?
No
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Key exclusion criteria
* Any medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that make the participant inappropriate for the study.
* Known history of active inflammatory gastrointestinal disease, chronic diarrhea, or previous gastric resection or lap-band surgery.
* Clinically significant cardiovascular disease.
* Known or suspected brain metastasis or active leptomeningeal disease or clinically significant history of seizure.
* Any history of myelodysplastic syndrome, acute myeloid leukemia, or any other prior malignancy with a few exceptions.
* Participants must be treatment naïve at the mCRPC stage, eg, no cytotoxic chemotherapy, radio-ligand therapy (i.e. 177Lu- PSMA-617), CDK4/6 inhibitors, 5-alpha reductase inhibitors for prostate cancer in any setting, androgen receptor signaling inhibitors (ARSi) including enzalutamide, apalutamide, darolutamide, poly ADP-ribose polymerase (PARP) monotherapy or other systemic anti-cancer treatment with the following exceptions:
1. Treatment with first-generation antiandrogen (ADT) agents;
2. Docetaxel treatment is allowed for mCSPC, as long as no signs of failure, or disease progression occurred during treatment or within 3 months of treatment completion.
* Previous administration with an investigational product (drug or vaccine) within 30 days or 5 half-lives preceding the first dose of study intervention (whichever is longer).
* Inadequate organ function.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
22/10/2024
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
30/11/2028
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Actual
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Sample size
Target
900
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Recruitment outside Australia
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United States of America
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Nebraska
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New York
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North Carolina
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South Carolina
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Washington
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Argentina
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Buenos Aires
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Ceará
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Brazil
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RIO Grande DO SUL
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Brazil
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SÃO Paulo
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Brazil
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São Paulo
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Bulgaria
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Gabrovo
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Pleven
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Plovdiv
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Sofia
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Stara Zagora
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Ontario
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Zhejiang
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Shenyang
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Czechia
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Praha 10
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Helsinki
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Aquitaine
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Finistère
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Germany
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Hamburg
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Hungary
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Nógrád
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Ehime
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Osaka
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Japan
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Tokyo
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Japan
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Fukuoka
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Japan
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Kumamoto
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Japan
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Yamagata
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Korea, Republic of
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Jeonranamdo
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Korea, Republic of
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Kyonggi-do
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Korea, Republic of
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Seoul-teukbyeolsi [seoul]
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Korea, Republic of
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Taegu-kwangyokshi
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Korea, Republic of
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Taejon-kwangyokshi
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Netherlands
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Gelderland
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Netherlands
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Zuid-holland
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New Zealand
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BAY OF Plenty
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New Zealand
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Canterbury
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New Zealand
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Waikato
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New Zealand
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Auckland
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Poland
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Dolnoslaskie
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Poland
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Kujawsko-pomorskie
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Poland
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Lubelskie
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Poland
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State/province [110]
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Malopolskie
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Poland
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State/province [111]
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Zachodniopomorskie
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Poland
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State/province [112]
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Lódzkie
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Slovakia
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Bratislava
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Slovakia
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Martin
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Slovakia
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Trencin
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South Africa
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Eastern CAPE
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South Africa
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Gauteng
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South Africa
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Western CAPE
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Spain
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Madrid, Comunidad DE
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Spain
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Valenciana, Comunitat
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Spain
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Madrid
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Sweden
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Stockholms LÄN [se-01]
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Taiwan
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Kaohsiung
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Taiwan
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Taichung
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Taiwan
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Tainan
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Taiwan
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Taipei
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Turkey
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State/province [127]
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I?stanbul
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Turkey
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State/province [128]
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Ankara
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United Kingdom
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State/province [129]
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Blackburn WITH Darwen
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United Kingdom
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Glasgow
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Pfizer
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
This study will explore whether a combination of the investigational drug PF-06821497 and enzalutamide will work better than taking enzalutamide alone in participants with mCRPC who are ARSi or abiraterone naïve.
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Trial website
https://clinicaltrials.gov/study/NCT06629779
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
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Pfizer CT.gov Call Center
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Pfizer
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Contact person for public queries
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0
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Pfizer CT.gov Call Center
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Address
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0
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0
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Phone
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1-800-718-1021
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Email
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[email protected]
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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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.
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When will data be available (start and end dates)?
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Available to whom?
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Available for what types of analyses?
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How or where can data be obtained?
IPD available at link: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests
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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/NCT06629779
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