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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT05367440
Registration number
NCT05367440
Ethics application status
Date submitted
19/04/2022
Date registered
10/05/2022
Date last updated
28/05/2024
Titles & IDs
Public title
Study of AZD5305 When Given in Combination With New Hormonal Agents in Patients With Metastatic Prostate Cancer
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Scientific title
A Multi-arm, Open-label Phase I/IIa Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of AZD5305 in Combination With New Hormonal Agents in Patients With Metastatic Prostate Cancer (PETRANHA)
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Secondary ID [1]
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2021-006289-19
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Secondary ID [2]
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D9720C00003
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Universal Trial Number (UTN)
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Trial acronym
PETRANHA
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Metastatic Prostate Cancer
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Condition category
Condition code
Cancer
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0
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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 - AZD5305
Treatment: Drugs - Enzalutamide
Treatment: Drugs - Abiraterone Acetate
Treatment: Drugs - Darolutamide
Treatment: Drugs - Apalutamide
Experimental: Arm 1 (AZD5305 in combination with enzalutamide) - Patients will receive an oral dose of AZD5305 and Enzalutamide once daily until disease progression, initiation of alternative anticancer therapy, unacceptable toxicity, withdrawal of consent, or other reasons to discontinue study treatment occur.
Experimental: Arm 2 (AZD5305 in combination with abiraterone acetate) - Patients will receive an oral dose of AZD5305 and Abiraterone Acetate once daily until disease progression, initiation of alternative anticancer therapy, unacceptable toxicity, withdrawal of consent, or other reasons to discontinue study treatment occur.
Experimental: Arm 3 (AZD5305 in combination with darolutamide) - Patients will receive an oral dose of AZD5305 once daily and Darolutamide twice daily until disease progression, initiation of alternative anticancer therapy, unacceptable toxicity, withdrawal of consent, or other reasons to discontinue study treatment occur.
Experimental: Arm 4 (AZD5305 in combination with apalutamide) - Patients will receive an oral dose of AZD5305 and Apalutamide once daily until disease progression, initiation of alternative anticancer therapy, unacceptable toxicity, withdrawal of consent, or other reasons to discontinue study treatment occur.
Treatment: Drugs: AZD5305
Patients will receive an oral dose of AZD5305 once daily
Treatment: Drugs: Enzalutamide
Patients will receive an oral dose of Enzalutamide once daily
Treatment: Drugs: Abiraterone Acetate
Patients will receive an oral dose of Abiraterone Acetate once daily
Treatment: Drugs: Darolutamide
Patients will receive an oral dose of Darolutamide twice daily
Treatment: Drugs: Apalutamide
Patients will receive an oral dose of Apalutamide once daily
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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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Number of patients with Adverse Events and Serious Adverse Events
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Assessment method [1]
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Number of patients with adverse events and with serious adverse events including abnormal clinical observations, abnormal ECG parameters, abnormal laboratory assessments and abnormal vital signs that changed from baseline will be assessed.
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Timepoint [1]
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Up to post treatment follow-up (28 days after last dose) [assessed up to 2.3 years]
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Primary outcome [2]
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Part A: Number of patients with Dose Limiting Toxicities (DLTs)
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Assessment method [2]
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To assess the safety and tolerability of AZD5305 when given in combination with NHA.
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Timepoint [2]
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For Arm 1: 35 days, For Arm 2 and 3: 28 days
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Secondary outcome [1]
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Area Under the concentration Curve (AUC) of AZD5305
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Assessment method [1]
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To characterise the PK (AUC) of AZD5305 at steady state after multiple dosing of AZD5305 monotherapy.
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Timepoint [1]
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At the end of Cycle 0 (Cycle 0 is of 7 days)
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Secondary outcome [2]
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Maximum plasma concentration (Cmax) of AZD5305
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Assessment method [2]
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To characterise the PK (Cmax) of AZD5305 at steady state after multiple dosing of AZD5305 monotherapy.
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Timepoint [2]
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At the end of Cycle 0 (Cycle 0 is of 7 days)
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Secondary outcome [3]
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Time to maximum concentration (tmax) of AZD5305
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Assessment method [3]
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To characterise the PK (tmax) of AZD5305 at steady state after multiple dosing of AZD5305 monotherapy.
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Timepoint [3]
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At the end of Cycle 0 (Cycle 0 is of 7 days)
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Secondary outcome [4]
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AUC of AZD5305
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Assessment method [4]
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To characterise the PK (AUC) of AZD5305 following oral dose administration of AZD5305 in combination with NHA.
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Timepoint [4]
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Arm 1: At Cycle 1 Day 1, Cycle 1 Day 22, Cycle 2 Day 1, Cycle 2 Day 2, Cycle 2 Day 8, and Cycle 3 Day 1; Arm 2 and 3: At Cycle 1 Day 1, Cycle 1 Day 15 and Cycle 2 Day 1 (Each Cycle is of 28 days)
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Secondary outcome [5]
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Cmax of AZD5305
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Assessment method [5]
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To characterise the PK (Cmax) of AZD5305 following oral dose administration of AZD5305 in combination with NHA.
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Timepoint [5]
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Arm 1: At Cycle 1 Day 1, Cycle 1 Day 22, Cycle 2 Day 1, Cycle 2 Day 2, Cycle 2 Day 8, and Cycle 3 Day 1; Arm 2 and 3: At Cycle 1 Day 1, Cycle 1 Day 15 and Cycle 2 Day 1 (Each Cycle is of 28 days)
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Secondary outcome [6]
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tmax of AZD5305
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Assessment method [6]
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To characterise the PK (tmax) of AZD5305 following oral dose administration of AZD5305 in combination with NHA.
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Timepoint [6]
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Arm 1: At Cycle 1 Day 1, Cycle 1 Day 22, Cycle 2 Day 1, Cycle 2 Day 2, Cycle 2 Day 8, and Cycle 3 Day 1; Arm 2 and 3: At Cycle 1 Day 1, Cycle 1 Day 15 and Cycle 2 Day 1 (Each Cycle is of 28 days)
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Secondary outcome [7]
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Objective response rate (ORR)
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Assessment method [7]
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To assess the preliminary antitumour activity of AZD5305 in combination with NHA. ORR will be assessed as per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 (soft tissue) and Prostate Cancer Clinical Trials Working Group 3 (PCWG3) and is defined as the percentage of patients who have a confirmed visit response of complete response (CR) or partial response (PR) in their soft tissue disease and no disease progression in their bone scan.
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Timepoint [7]
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From Screening (Day -28) to confirmed disease progression [assessed up to 2.3 years]
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Secondary outcome [8]
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Duration of response (DoR)
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Assessment method [8]
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To assess the preliminary antitumour activity of AZD5305 in combination with NHA. DoR is defined as the time from the date of first documented response (which is subsequently confirmed) until date of documented progression or death in the absence of progressive disease (PD).
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Timepoint [8]
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From Screening (Day -28) to confirmed disease progression [assessed up to 2.3 years]
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Secondary outcome [9]
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Time to response (TTR)
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Assessment method [9]
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To assess the preliminary antitumour activity of AZD5305 in combination with NHA. TTR is defined as the time from first dose until the first documentation of a subsequently confirmed objective response.
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Timepoint [9]
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From Screening (Day -28) to confirmed disease progression [assessed up to 2.3 years]
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Secondary outcome [10]
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Radiographic progression-free survival (rPFS)
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Assessment method [10]
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To assess the preliminary antitumour activity of AZD5305 in combination with NHA. rPFS is defined as the time from start of first treatment until progression as per RECIST v1.1 (soft tissue) and PCWG3 criteria (bone) or death from any cause.
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Timepoint [10]
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From Screening (Day -28), 12 months, 24 months and up to confirmed disease progression [assessed up to 2.3 years]
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Secondary outcome [11]
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Percentage change in tumour size
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Assessment method [11]
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To assess the preliminary antitumour activity of AZD5305 in combination with NHA. Percentage change in tumour size will be determined for patients with measurable disease at baseline.
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Timepoint [11]
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From Screening (Day -28) to confirmed disease progression [assessed up to 2.3 years]
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Secondary outcome [12]
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Number of patients with = 50% prostate-specific antigen (PSA) decrease from baseline
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Assessment method [12]
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To assess the preliminary antitumour activity of AZD5305 in combination with NHA.
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Timepoint [12]
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From Screening (Day -28) to confirmed disease progression [assessed up to 2.3 years]
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Secondary outcome [13]
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Number of patients with = 90% prostate-specific antigen (PSA) decrease from baseline
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Assessment method [13]
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To assess the preliminary antitumour activity of AZD5305 in combination with NHA.
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Timepoint [13]
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From Screening (Day -28) to confirmed disease progression [assessed up to 2.3 years]
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Secondary outcome [14]
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Part B: Number of patients with undetectable PSA (< 0.2 ng/mL)
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Assessment method [14]
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To assess the preliminary antitumour activity of AZD5305 in combination with NHA.
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Timepoint [14]
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3, 6, 9 and 12 months
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Secondary outcome [15]
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PSA Progression-free survival
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Assessment method [15]
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To assess the preliminary antitumour activity of AZD5305 in combination with NHA.
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Timepoint [15]
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6, 12, 18, 24 and 30 months
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Secondary outcome [16]
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AUC of Enzalutamide
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Assessment method [16]
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To characterize the PK (AUC) of Enzalutamide in plasma at steady state when given orally in combination with AZD5305
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Timepoint [16]
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At Cycle 1 Day 22, Cycle 2 Day 1, Cycle 2 Day 2, Cycle 2 Day 8 and Cycle 3 Day 1 (Each Cycle is of 28 days)
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Secondary outcome [17]
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Cmax of Enzalutamide
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Assessment method [17]
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To characterize the PK (Cmax) of Enzalutamide in plasma at steady state when given orally in combination with AZD5305
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Timepoint [17]
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At Cycle 1 Day 22, Cycle 2 Day 1, Cycle 2 Day 2, Cycle 2 Day 8 and Cycle 3 Day 1 (Each Cycle is of 28 days)
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Secondary outcome [18]
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0
tmax of Enzalutamide
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Assessment method [18]
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To characterize the PK (tmax) of Enzalutamide in plasma at steady state when given orally in combination with AZD5305
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Timepoint [18]
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At Cycle 1 Day 22, Cycle 2 Day 1, Cycle 2 Day 2, Cycle 2 Day 8 and Cycle 3 Day 1 (Each Cycle is of 28 days)
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Secondary outcome [19]
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AUC of Apalutamide
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Assessment method [19]
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To characterize the PK (AUC) of Apalutamide in plasma at steady state when given orally in combination with AZD5305
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Timepoint [19]
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At Cycle 1 Day 22, Cycle 2 Day 1, Cycle 2 Day 2, Cycle 2 Day 8 and Cycle 3 Day 1 (Each Cycle is of 28 days)
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Secondary outcome [20]
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Cmax of Apalutamide
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Assessment method [20]
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To characterize the PK (Cmax) of Apalutamide in plasma at steady state when given orally in combination with AZD5305
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Timepoint [20]
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At Cycle 1 Day 22, Cycle 2 Day 1, Cycle 2 Day 2, Cycle 2 Day 8 and Cycle 3 Day 1 (Each Cycle is of 28 days)
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Secondary outcome [21]
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0
tmax of Apalutamide
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Assessment method [21]
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To characterize the PK (tmax) of Apalutamide in plasma at steady state when given orally in combination with AZD5305
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Timepoint [21]
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At Cycle 1 Day 22, Cycle 2 Day 1, Cycle 2 Day 2, Cycle 2 Day 8 and Cycle 3 Day 1 (Each Cycle is of 28 days)
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Secondary outcome [22]
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Part B: Homologous recombination repair gene mutation (HRRRm)
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Assessment method [22]
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To investigate HRRm (including BRCA1/2) and their relationship with clinical response
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Timepoint [22]
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From Screening (Day -28) to confirmed disease progression [assessed up to 2.3 years]
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Eligibility
Key inclusion criteria
For whole study:
- Age = 18 at the time of screening.
- Histologically confirmed diagnosis of metastatic prostate cancer.
- Candidate for treatment with enzalutamide, abiraterone acetate, darolutamide or
apalutamide with documented current evidence of metastatic prostate cancer.
- Surgically or medically castrated.
- Adequate organ and marrow function.
- Eastern Cooperative Oncology Group Performance Status (ECOG PS): 0-1 with no
deterioration over the previous 2 weeks.
- Life expectancy = 16 weeks.
- Non-sterilized male patients who are sexually active with a female partner of
childbearing potential must use a condom with spermicide from screening to
approximately 6 months after the last dose of study treatment .
For Patients Recruited Specifically to tumour Pharmacodynamic Cohorts:
• Patients must have at least 1 tumour suitable for paired biopsies
For Part A:
• Patients with Metastatic Castrate ion-Resistant Prostate Cancer (mCRPC) or Metastatic
Castration Sensitive Prostate Cancer (mCSPC).
For Part B:
• Patients must have mCSPC (de novo or recurrent) with a baseline PSA value of = 0.2 ng/mL
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Minimum age
18
Years
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Maximum age
130
Years
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Sex
Males
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Can healthy volunteers participate?
No
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Key exclusion criteria
For Part A mCRPC patients only:
- Any previous treatment with a new hormonal agent (NHA), poly (adenosine
diphosphateribose) polymerase inhibitor (PARPi), Lutetium prostate-specific membrane
antigen (Lu-PSMA), platinum chemotherapy
- Patients recruited to the PDc cohorts should not have received a prior use of new
hormonal agents (NHA).
For Part A and Part B mCSPC Patients:
- Any previous treatment with a PARPi, platinum, NHA, Immuno-oncology (IO),
radiopharmaceutical therapy, or prior treatment with docetaxel in mCSPC setting.
- Concomitant use of medications or herbal supplements known to be:
1. Strong and moderate CYP3A4 inducers/inhibitors (applies for all arms)
2. For Arm 1 (enzalutamide) patients: Strong CYP2C8 inhibitors
3. For Arm 3 (darolutamide) patients: Strong P-glycoprotein inducers
- Concomitant use of drugs that are known to prolong or shorten QT and have a known risk
of Torsades de Pointes.
- Treatment with any of the following:
1. Any investigational agents or study interventions from a previous clinical study
within 5 half lives or 3 weeks (whichever is longer) of the first dose of study
treatment.
2. Any other anticancer treatment within the following time periods prior to the
first dose of study treatment: (i) Cytotoxic and non-cytotoxic treatment: 3 weeks
or 5 half-lives (whichever is shorter). (ii) Biological products including
immuno-oncology agents: 4 weeks before enrolment.
3. Any live virus or bacterial vaccine within 28 days of the first dose of study
treatment.
- Any concurrent anticancer therapy or concurrent use of prohibited medications.
- Major surgery within 4 weeks prior to the first dose of study treatment.
- Radiotherapy with a wide field of radiation within 4 weeks or radiotherapy with a
limited field of radiation for palliation within 2 weeks of the first dose of study
treatment.
- With the exception of alopecia, and peripheral neuropathy; any unresolved toxicities
from prior therapy greater than Common Terminology Criteria for Adverse Events (CTCAE)
Grade 1 at the time of study enrolment.
- Any history of persisting (> 2 weeks) severe pancytopenia.
- Spinal cord compression, or brain metastases unless asymptomatic and treated and
stable.
- Any evidence of severe or uncontrolled systemic diseases, including, active bleeding
diatheses, or active infection including hepatitis B, hepatitis C and human
immunodeficiency virus (HIV).
- Patients with any known predisposition to bleeding (eg, active peptic ulceration,
recent [within 6 months] haemorrhagic stroke, proliferative diabetic retinopathy.
- Any clinically significant cardiac disorders including QT prolongation, abnormal
electrocardiogram (ECG).
- Any clinically significant cardiovascular diseases including symptomatic heart
failure, uncontrolled hypertension, acute coronary syndrome, cardiomyopathy, valvular
heart disease, atrial fibrillation, stroke.
- Patients with history of myelodysplastic syndrome (MDS)/ acute myeloid leukaemia
(AML).
- Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to
swallow the formulated product or previous significant bowel resection.
- Known allergy or hypersensitivity to investigational product(s) or any of the
excipients of the investigational product(s).
- Any condition that would interfere with evaluation of the study treatment or
interpretation of patient safety or study results.
- Uncontrolled intercurrent illness within the last 12 months, including but not limited
to, active interstitial lung disease, serious chronic gastrointestinal (GI) conditions
associated with diarrhoea, or psychiatric illness/social situations
- History of another primary malignancy except for malignancy treated with curative
intent with no known active disease within 3 years before the first dose of study
treatment and of low potential risk for recurrence.
- Concurrent enrolment in another clinical study, unless it is an observational
(non-interventional) clinical study or during the follow-up period of an
interventional study.
- Arm 1 (Enzalutamide) and Arm 4 (Apalutamide): History of seizure or any condition that
may predispose to seizure (eg, prior cortical stroke, significant brain trauma).
- Arm 2 (Abiraterone acetate) only: (i) Active infection or other medical condition that
would contraindicate the use of systemic steroids (prednisone/prednisolone). (ii) Low
serum potassium (< 3.5 mmol/L). (iii) History of uncontrolled pituitary or adrenal
dysfunction.
- Arm 4 (Apalutamide): (i) Moderate or severe skin conditions or diseases that could
affect the skin (eg. scleroderma, lupus). (ii) Any skin or medical condition that in
the Investigator's opinion could increase the risk of skin toxicity.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised 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 1/Phase 2
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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
2/06/2022
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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
15/08/2030
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Actual
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Sample size
Target
172
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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 hospital [1]
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Research Site - Camperdown
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Recruitment hospital [2]
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Research Site - Darlinghurst
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Recruitment hospital [3]
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Research Site - East Melbourne
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Recruitment hospital [4]
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Research Site - Heidelberg
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Recruitment hospital [5]
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Research Site - Melbourne
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Recruitment hospital [6]
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Research Site - St. Leonards
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Recruitment postcode(s) [1]
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2050 - Camperdown
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Recruitment postcode(s) [2]
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2010 - Darlinghurst
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Recruitment postcode(s) [3]
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3002 - East Melbourne
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Recruitment postcode(s) [4]
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3084 - Heidelberg
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Recruitment postcode(s) [5]
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3004 - Melbourne
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Recruitment postcode(s) [6]
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2065 - St. Leonards
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Recruitment outside Australia
Country [1]
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0
United States of America
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State/province [1]
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0
California
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Country [2]
0
0
United States of America
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State/province [2]
0
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Indiana
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Country [3]
0
0
United States of America
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State/province [3]
0
0
Michigan
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Country [4]
0
0
United States of America
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State/province [4]
0
0
New York
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Country [5]
0
0
United States of America
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State/province [5]
0
0
Pennsylvania
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Country [6]
0
0
United States of America
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State/province [6]
0
0
South Carolina
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Country [7]
0
0
United States of America
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State/province [7]
0
0
Texas
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Country [8]
0
0
Italy
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State/province [8]
0
0
Candiolo
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Country [9]
0
0
Italy
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State/province [9]
0
0
Milano
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Country [10]
0
0
Italy
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State/province [10]
0
0
Orbassano
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Country [11]
0
0
Italy
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State/province [11]
0
0
Padova
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Country [12]
0
0
Italy
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State/province [12]
0
0
Pavia
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Country [13]
0
0
United Kingdom
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State/province [13]
0
0
Cambridge
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Country [14]
0
0
United Kingdom
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State/province [14]
0
0
Glasgow
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Country [15]
0
0
United Kingdom
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State/province [15]
0
0
Hampshire
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Country [16]
0
0
United Kingdom
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State/province [16]
0
0
Manchester
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Country [17]
0
0
United Kingdom
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State/province [17]
0
0
Newcastle Upon Tyne
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Country [18]
0
0
United Kingdom
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State/province [18]
0
0
Plymouth
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
AstraZeneca
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Address
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Country
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Other collaborator category [1]
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0
Commercial sector/Industry
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Name [1]
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Bayer
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Address [1]
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0
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Country [1]
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0
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Ethics approval
Ethics application status
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Summary
Brief summary
This study will evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics,
and preliminary efficacy of AZD5305 when given in combination with new hormonal agents (NHAs)
in patients with Metastatic Prostate Cancer.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT05367440
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Address
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Country
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Phone
0
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Fax
0
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Email
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Contact person for public queries
Name
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AstraZeneca Clinical Study Information Center
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Address
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0
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Country
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0
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Phone
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1-877-240-9479
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Fax
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0
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Email
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0
[email protected]
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT05367440
Download to PDF