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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT06136650
Registration number
NCT06136650
Ethics application status
Date submitted
13/11/2023
Date registered
18/11/2023
Titles & IDs
Public title
A Study of Opevesostat (MK-5684) Versus Alternative Next-generation Hormonal Agent (NHA) in Metastatic Castration-resistant Prostate Cancer (mCRPC) Post One NHA (MK-5684-004)
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Scientific title
A Phase 3, Randomized, Open-label Study of MK-5684 Versus Alternative Abiraterone Acetate or Enzalutamide in Participants With Metastatic Castration-resistant Prostate Cancer (mCRPC) That Progressed On or After Prior Treatment With One Next-generation Hormonal Agent (NHA)
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Secondary ID [1]
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MK-5684-004
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Secondary ID [2]
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5684-004
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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 (mCRPC)
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Prostatic Neoplasms
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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 - Opevesostat
Treatment: Drugs - Dexamethasone
Treatment: Drugs - Fludrocortisone acetate
Treatment: Drugs - Hydrocortisone
Treatment: Drugs - Abiraterone acetate
Treatment: Drugs - Prednisone acetate
Treatment: Drugs - Enzalutamide
Experimental: hormone replacement therapy (HRT)+ opevesostat - Participants receive opevesostat 5 mg by oral tablets twice daily (BID) plus dexamethasone 1.5 mg by oral tablets and fludrocortisone acetate 0.1 mg oral tablet once daily (QD) continuously until disease progression. Hydrocortisone 100 mg (oral or intramuscular \[IM\]) will also be provided to participants for use as rescue medication.
Active comparator: Alternative next generation hormonal agent (NHA) - Participants receive Abiraterone 1000 mg QD by oral tablets plus Prednisone 5 mg BID by oral tablets or Enzalutamide 160 mg QD by oral tablets until disease progression.
Treatment: Drugs: Opevesostat
Administered orally
Treatment: Drugs: Dexamethasone
Administered orally
Treatment: Drugs: Fludrocortisone acetate
Administered orally
Treatment: Drugs: Hydrocortisone
Administered orally or IM as a rescue drug
Treatment: Drugs: Abiraterone acetate
Administered orally
Treatment: Drugs: Prednisone acetate
Administered orally
Treatment: Drugs: Enzalutamide
Administered orally
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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 randomization to the first documented disease progression per PCWG-modified RECIST 1.1 by BICR or death due to any cause, whichever occurs first.
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Timepoint [1]
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Up to approximately 82 months
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Primary outcome [2]
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Overall Survival (OS)
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Assessment method [2]
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OS is defined as the time from randomization to death due to any cause.
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Timepoint [2]
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Up to approximately 82 months
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Secondary outcome [1]
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Time to Initiation of the First Subsequent Anticancer Therapy (TFST)
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Assessment method [1]
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TFST is defined as the time from randomization to initiation of the first subsequent anti-cancer therapy or death; whichever occurred first.
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Timepoint [1]
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Up to approximately 82 months
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Secondary outcome [2]
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Objective Response Rate (ORR)
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Assessment method [2]
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ORR is defined as the percentage of participants with Complete Response (CR) or Partial Response (PR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1). The percentage of participants who experience CR or PR as assessed by Blinded Independent Central Review (BICR) will be presented.
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Timepoint [2]
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Up to approximately 82 months
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Secondary outcome [3]
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Duration of Response (DOR)
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Assessment method [3]
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For participants who demonstrate confirmed CR or PR, duration of response is defined as the time from the first documented evidence of CR or PR until disease progression per PCWG-modified RECIST 1.1 as assessed by BICR or death from any cause, whichever occurs first.
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Timepoint [3]
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Up to approximately 82 months
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Secondary outcome [4]
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Time to Pain Progression (TTPP)
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Assessment method [4]
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TTPP is defined as the time from randomization to pain progression. TTTP is assessed by Brief Pain Inventory-Short Form (BPI-SF) Item 3 ("Worst Pain in 24 Hours") and opiate analgesic use (Analgesic Quantification Algorithm \[AQA\] Score).
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Timepoint [4]
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Up to approximately 82 months
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Secondary outcome [5]
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Prostrate-specific Antigen (PSA) Response Rate
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Assessment method [5]
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The Prostate-specific Antigen (PSA) response rate is the percentage of participants who had PSA response defined as a reduction in the PSA level from baseline by =50%. The reduction in PSA level was confirmed by an additional PSA evaluation performed =3 weeks from the original response.
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Timepoint [5]
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Up to approximately 82 months
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Secondary outcome [6]
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Time to Prostate-specific Antigen (PSA) Progression
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Assessment method [6]
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The time to PSA progression is the time from randomization to PSA progression. The PSA progression date is defined as the date of: 1) =25% increase and =2 ng/mL above the nadir, confirmed by a second value =3 weeks later if there was PSA decline from baseline; OR 2) =25% increase and =2 ng/mL increase from baseline.
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Timepoint [6]
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Up to approximately 82 months
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Secondary outcome [7]
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Time to first symptomatic skeletal-related event (TSSRE)
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Assessment method [7]
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TSSRE is the time from randomization to the first symptomatic skeletal-related event defined as: 1. use of external-beam radiation therapy (EBRT) to prevent or relieve skeletal symptoms 2. occurrence of new symptomatic pathologic bone fracture (vertebral or non-vertebral) 3. occurrence of spinal cord compression 4. tumor-related orthopedic surgical intervention, whichever occurs first.
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Timepoint [7]
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Up to approximately 82 months
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Secondary outcome [8]
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Number of Participants Who Experience an Adverse Event (AE)
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Assessment method [8]
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An AE is defined as any unfavorable and unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment. The number of participants who experience one or more AE will be reported.
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Timepoint [8]
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Up to approximately 82 months
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Secondary outcome [9]
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Number of Participants Who Discontinue Study Treatment Due to an AE
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Assessment method [9]
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An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment. The number of participants who discontinue study treatment due to an AE will be reported.
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Timepoint [9]
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Up to approximately 82 months
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Secondary outcome [10]
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Change From Baseline in Functional Assessment of Cancer Therapy-General (FACT-G) Total Score
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Assessment method [10]
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The FACT-G is a health-related quality of life (HRQoL) 27-item questionnaire in participants being treated for cancer. The FACT-G subscales include Physical Well-Being (PWB), Social/Family Well-Being (SWB), Emotional Well-Being (EWB), and Functional Well-Being (FWB). All items are scored on a 5-point Likert scale of 0 (not at all) to 4 (very much). The total score can range from 0 to 108. Higher scores indicate higher HRQoL. The change from baseline in FACT-G total score will be reported.
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Timepoint [10]
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Baseline, and up to approximately 82 months
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Secondary outcome [11]
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Time to Deterioration (TTD) in FACT-G Total Score
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Assessment method [11]
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The FACT-G is a health-related quality of life (HRQoL) 27-item questionnaire in participants being treated for cancer. The FACT-G subscales include Physical Well-Being (PWB), Social/Family Well-Being (SWB), Emotional Well-Being (EWB), and Functional Well-Being (FWB). All items are scored on a 5-point Likert scale of 0 (not at all) to 4 (very much). The total score can range from 0 to 108. Higher scores indicate higher HRQoL. TTD in FACT-G total score will be reported.
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Timepoint [11]
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Up to approximately 82 months
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Secondary outcome [12]
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Overall Improvement in FACT-G Total Score
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Assessment method [12]
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The FACT-G is a health-related quality of life (HRQoL) 27-item questionnaire in participants being treated for cancer. The FACT-G subscales include Physical Well-Being (PWB), Social/Family Well-Being (SWB), Emotional Well-Being (EWB), and Functional Well-Being (FWB). All items are scored on a 5-point Likert scale of 0 (not at all) to 4 (very much). The total score can range from 0 to 108. Higher scores indicate higher HRQoL. The overall improvement in FACT-G total score will be reported.
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Timepoint [12]
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Up to approximately 82 months
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Eligibility
Key inclusion criteria
The main inclusion criteria include but are not limited to the following:
* Have histologically or cytologically confirmed adenocarcinoma of the prostate without small cell histology
* Has current evidence of metastatic disease documented by either bone lesions on bone scan and/or soft tissue disease shown by computed tomography scan (CT)/magnetic resonance imaging (MRI)
* Has prostate cancer progression while receiving androgen deprivation therapy (ADT) (or post bilateral orchiectomy) within 6 months before screening
* Has disease that progressed during or after treatment with one next-generation hormonal agent (NHA) for hormone sensitive prostate cancer (HSPC) metastatic hormone sensitive prostate cancer (mHSPC) or non metastatic hormone sensitive prostate cancer (nmHSPC), for at least 8 weeks (at least 14 weeks for participants with bone progression) Note: Participants may have received abiraterone acetate and docetaxel or darolutamide and docetaxel for HSPC. However, participants must have received no more than six cycles of docetaxel and had no radiographic disease progression while receiving docetaxel
* Has an eastern clinical oncology group (ECOG) performance status of 0 or 1 assessed within 7 days before randomization
* Has ongoing androgen deprivation with serum testosterone <50 ng/dL (<1.7 nM)
* Has had prior treatment with Poly polymerase inhibitors (PARPi) or were deemed ineligible to receive treatment by the investigator or have refused PARPi treatment
* Has adequate organ function
* Has provided tumor tissue from a fresh core or excisional biopsy from soft tissue not previously irradiated. Samples from tumors progressing at a prior site of radiation are allowed
* Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks and have undetectable HBV viral load before randomization
* Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at Screening
* Participants who have adverse event (AEs) due to previous anticancer therapies must have recovered to =Grade 1 or baseline. Participants with endocrine-related AEs who are adequately treated with hormone replacement therapy (HRT) or participants who have =Grade 2 neuropathy are eligible
* Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy (ART)
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
The main exclusion criteria include but are not limited to the following:
* Has presence of gastrointestinal condition
* Is unable to swallow capsules/tablets
* Has history of pituitary dysfunction
* Has poorly controlled diabetes mellitus
* Has a history of active or unstable cardio/cerebro-vascular disease, including thromboembolic events
* Has clinically significant abnormal serum potassium or sodium level
* Has any of the following at screening visit: Hypotension: systolic blood pressure (BP) <110 mmHg, or Uncontrolled hypertension: systolic BP >160mmHg or diastolic blood BP >90 mmHg, in 2 out of the 3 recordings with optimized antihypertensive therapy
* History or family history of long QTc syndrome
* Has a history of seizure(s) within 6 months prior to signing the informed consent (IC) or has any condition that may predispose to seizure within 12 months prior to the date of enrollment
* Has a history of clinically significant ventricular arrhythmias or Mobitz II second degree or third-degree heart block without a permanent pacemaker in place
* Has received a taxane-based chemotherapy and or NHA for metastatic castration-resistant prostate cancer (mCRPC)
* Has not adequately recovered from major surgery or have ongoing surgical complications
* Has received prior treatment with radium for prostate cancer
* Is currently being treated with Cytochrome P450 (CYP450)-inducing antiepileptic drugs for seizures
* Participants on an unstable dose of thyroid hormone therapy within 6 months before the start of the study intervention
* Receives prior radiotherapy within 2 weeks before the first dose of study intervention, or radiation-related toxicities, requiring corticosteroids
* Receives prior systemic anticancer therapy including investigational agents within 4 weeks before the first dose of study intervention
* Has systemic use of strong Cytochrome P450 3A4 (CYP3A4) inducers and P-glycoprotein (P-gp) inhibitors within 2 weeks before the first dose of study intervention
* Has received prior targeted small molecule therapy or NHA treatment within 4 weeks before the first dose of study intervention
* Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention
* Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration
* Has known hypersensitivity to the components or excipients in abiraterone acetate, prednisone or prednisolone, enzalutamide, fludrocortisone, dexamethasone, or opevesostat.
* Has a "superscan" bone scan defined as an intense symmetric activity in the bones and diminished renal parenchymal activity on baseline bone scan such that the presence of additional metastases in the future could not be evaluated
* Has known additional malignancy that is progressing or has required active treatment within the past 3 years
* Diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior the first dose of study medication
* Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable, (ie, without evidence of progression) for at least 4 weeks as confirmed by repeat imaging performed during study screening, are clinically stable and have not required steroid treatment for at least 14 days prior to the first dose of study intervention
* Has active autoimmune disease that has required systemic treatment in the past 2 years. Replacement therapy is allowed
* Active infection requiring systemic therapy
* Has concurrent active Hepatitis B virus and Hepatitis C virus infection
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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
Open (masking not used)
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Who is / are masked / blinded?
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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
18/12/2023
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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
2/12/2030
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Actual
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Sample size
Target
1500
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
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Recruitment hospital [1]
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Macquarie University-MQ Health Clinical Trials Unit ( Site 0214) - Macquarie University
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Recruitment hospital [2]
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Westmead Hospital-Department of Medical Oncology ( Site 0212) - Westmead
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Recruitment hospital [3]
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Royal Brisbane and Women's Hospital-Medical Oncology Clinical Trials Unit, Cancer Care Services ( Si - Brisbane
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Recruitment hospital [4]
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Monash Health ( Site 0219) - Clayton
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Recruitment hospital [5]
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Peter MacCallum Cancer Centre-Parkville Cancer Clinical Trials Unit (PCCTU) ( Site 0210) - Melbourne
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Recruitment postcode(s) [1]
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2109 - Macquarie University
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Recruitment postcode(s) [2]
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2145 - Westmead
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Recruitment postcode(s) [3]
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4029 - Brisbane
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Recruitment postcode(s) [4]
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3168 - Clayton
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Recruitment postcode(s) [5]
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3000 - Melbourne
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Recruitment outside Australia
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United States of America
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California
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Colorado
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Illinois
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Indiana
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Kentucky
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Maryland
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Michigan
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Nebraska
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Nevada
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Sao Paulo
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Chile
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Araucania
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Chile
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Maule
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Chile
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Region M. De Santiago
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Chile
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Valparaiso
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China
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Anhui
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China
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Beijing
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China
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Chongqing
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Fujian
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Sichuan
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China
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Tianjin
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China
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Xinjiang
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China
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Yunnan
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China
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Zhejiang
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Costa Rica
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San Jose
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Czechia
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Praha 5
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Olomouc
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Alsace
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France
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Aquitaine
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France
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Finistere
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France
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France
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France
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France
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France
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Germany
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Bayern
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Germany
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Hessen
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Germany
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Niedersachsen
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Germany
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Germany
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Sachsen
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Germany
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Berlin
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Achaia
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Greece
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Attiki
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Guatemala
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Ciudad de Guatemala
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Guatemala
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Guatemala
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Hong Kong
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Central
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Hksar
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Hungary
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Borsod-Abauj-Zemplen
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Hungary
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Nograd
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Hungary
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Pest
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Hungary
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Debrecen
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Ireland
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Dublin
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Israel
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Afula
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Israel
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Haifa
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Israel
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Jerusalem
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Israel
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Kfar Saba
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Israel
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Petah Tikva
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Israel
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Ramat Gan
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Israel
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Tel Aviv
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Italy
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Emilia-Romagna
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Italy
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Lombardia
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Italy
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Catania
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Italy
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Foggia
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Italy
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Milano
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Japan
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Chiba
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Japan
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Fukui
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Japan
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Fukuoka
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Japan
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Hokkaido
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Japan
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Hyogo
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Japan
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Ishikawa
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Japan
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Kagawa
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Japan
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Kanagawa
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Japan
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Mie
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Japan
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Nagasaki
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Japan
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Nara
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Japan
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Okinawa
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Japan
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Osaka
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Japan
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Saga
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Japan
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Akita
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Japan
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Gifu
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Japan
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Hiroshima
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Japan
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Japan
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Kumamoto
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Japan
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Miyazaki
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Japan
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Nagano
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Japan
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Oita
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Japan
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Tokyo
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Korea, Republic of
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Korea, Republic of
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Seoul
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Latvia
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Riga
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Kauno Apskritis
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Lithuania
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Vilniaus Miestas
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Johor
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Auckland
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Portugal
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Lisboa
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Portugal
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Porto
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Portugal
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Braga
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Ponce
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Puerto Rico
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San Juan
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Romania
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Bucuresti
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Romania
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Cluj
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Romania
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Dolj
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Singapore
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Central Singapore
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Nitriansky Kraj
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Western Cape
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Barcelona
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Gerona
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Las Palmas
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Spain
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Madrid
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Spain
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Kaohsiung
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Taoyuan
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Turkey
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Adana
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Ankara
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Turkey
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Istanbul
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United Kingdom
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Cambridgeshire
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United Kingdom
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Derbyshire
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Devon
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United Kingdom
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England
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United Kingdom
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Glasgow City
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United Kingdom
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Hammersmith And Fulham
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United Kingdom
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London, City Of
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United Kingdom
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Oxfordshire
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United Kingdom
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Windsor And Maidenhead
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United Kingdom
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Manchester
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Merck Sharp & Dohme LLC
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Address
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Other collaborator category [1]
0
0
Commercial sector/industry
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Name [1]
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Orion Corporation, Orion Pharma
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Ethics approval
Ethics application status
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Summary
Brief summary
The purpose of this study is to assess the efficacy and safety of opevesostat plus hormone replacement therapy (HRT) compared to alternative abiraterone acetate or enzalutamide in participants with Metastatic Castration-resistant Prostate Cancer (mCRPC) previously treated with one next-generation hormonal agent (NHA). The primary study hypotheses are that opevesostat is superior to alternative abiraterone acetate or enzalutamide with respect to radiographic progression free survival (rPFS) per Prostate Cancer Working Group (PCWG) Modified Response Evaluation Criteria in Solid Tumors (RECIST 1.1) as assessed by Blinded Independent Central Review (BICR) and overall survival (OS), in androgen receptor ligand binding domain (AR LBD) mutation positive and negative participants.
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Trial website
https://clinicaltrials.gov/study/NCT06136650
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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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Medical Director
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Address
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Merck Sharp & Dohme LLC
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Contact person for public queries
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Toll Free Number
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Phone
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1-888-577-8839
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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?
http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
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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: http://engagezone.msd.com/ds_documentation.php
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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/NCT06136650