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Study of AZD5305 When Given in Combination With New Hormonal Agents in Patients With Metastatic Prostate Cancer
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.
Study details:
The study consists of 2 parts, Part A and Part B. Part A consists of the dose escalation cohorts and will include patients with metastatic castration resistant prostate cancer (mCRPC) or metastatic castration-sensitive prostate cancer (mCSPC); Part B consists of dose expansion cohorts and will include patients with mCSPC only. Part A comprises 4 individual arms each evaluating the safety, tolerability, and preliminary efficacy of AZD5305 in combination with a specific new hormonal agent (NHA).
Part B comprises up to 4 individual arms (arms to be opened at Sponsor's discretion) each investigating the preliminary efficacy and aims to further build on the safety data for the combination of AZD5305 with a specific NHA. Approximately 783 patients will be enrolled and screened to ensure the required number of evaluable patients in each part and arm are enrolled. For Part A, 356 patients may be screened to obtain up to approximately 308 patients that can be assigned to study treatments across all study arms (1 to 4).
For Part B dose expansion cohorts, up to 427 patients may be screened to obtain up to approximately 360 patients that can be assigned to study treatments across all study arms (1 to 4). Study treatment administration will continue until disease progression, initiation of alternative anticancer therapy, unacceptable toxicity, withdrawal of consent, or other reasons to discontinue study treatment occur.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
Exclusion criteria
Eligibility
Age eligible for study : 18 and older
Healthy volunteers accepted : No
Gender eligible for study: Male
Things to know
Study dates
Study start: 2022-06-02
Primary completion: 2030-11-07
Study completion finish: 2030-11-07
Study type
TREATMENT
Phase
PHASE1
PHASE2
Trial ID
NCT05367440
Intervention or treatment
DRUG: AZD5305
DRUG: Enzalutamide
DRUG: Abiraterone Acetate
DRUG: Darolutamide
DRUG: Apalutamide
Conditions
- • Metastatic Prostate Cancer
Find a site
Closest Location:
Research Site
Research sites nearby
Select from list below to view details:
Research Site
Camperdown, Not Specified, Australia
Research Site
Darlinghurst, Not Specified, Australia
Research Site
East Melbourne, Not Specified, Australia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Participant Group/Arm | Intervention/Treatment |
---|---|
EXPERIMENTAL: Arm 1 (AZD5305 in combination with enzalutamide)
| DRUG: AZD5305
|
EXPERIMENTAL: Arm 2 (AZD5305 in combination with abiraterone acetate)
| DRUG: AZD5305
|
EXPERIMENTAL: Arm 3 (AZD5305 in combination with darolutamide)
| DRUG: AZD5305
|
EXPERIMENTAL: Arm 4 (AZD5305 in combination with apalutamide)
| DRUG: Apalutamide
|
What is the study measuring?
Primary outcome
Primary Outcome Measure | Primary Outcome Description | Primary Outcome Time Frame |
---|---|---|
Number of patients with Adverse Events and Serious Adverse Events | 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. | Up to post treatment follow-up (28 days after last dose) [assessed up to 2.3 years] |
Part A: Number of patients with Dose Limiting Toxicities (DLTs) | To assess the safety and tolerability of AZD5305 when given in combination with NHA. | For Arm 1: 35 days, For Arm 2 and 3: 28 days |
Secondary outcome
Secondary Outcome Measure | Secondary Outcome Description | Secondary Outcome Time Frame |
---|---|---|
Area Under the concentration Curve (AUC) of AZD5305 | To characterise the PK (AUC) of AZD5305 at steady state after multiple dosing of AZD5305 monotherapy. | At the end of Cycle 0 (Cycle 0 is of 7 days) |
Maximum plasma concentration (Cmax) of AZD5305 | To characterise the PK (Cmax) of AZD5305 at steady state after multiple dosing of AZD5305 monotherapy. | At the end of Cycle 0 (Cycle 0 is of 7 days) |
Time to maximum concentration (tmax) of AZD5305 | To characterise the PK (tmax) of AZD5305 at steady state after multiple dosing of AZD5305 monotherapy. | At the end of Cycle 0 (Cycle 0 is of 7 days) |
AUC of AZD5305 | To characterise the PK (AUC) of AZD5305 following oral dose administration of AZD5305 in combination with NHA. | 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) |
Cmax of AZD5305 | To characterise the PK (Cmax) of AZD5305 following oral dose administration of AZD5305 in combination with NHA. | 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) |
tmax of AZD5305 | To characterise the PK (tmax) of AZD5305 following oral dose administration of AZD5305 in combination with NHA. | 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) |
Objective response rate (ORR) | 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. | From Screening (Day -28) to confirmed disease progression [assessed up to 2.3 years] |
Duration of response (DoR) | 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). | From Screening (Day -28) to confirmed disease progression [assessed up to 2.3 years] |
Time to response (TTR) | 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. | From Screening (Day -28) to confirmed disease progression [assessed up to 2.3 years] |
Radiographic progression-free survival (rPFS) | 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. | From Screening (Day -28), 12 months, 24 months and up to confirmed disease progression [assessed up to 2.3 years] |
Percentage change in tumour size | 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. | From Screening (Day -28) to confirmed disease progression [assessed up to 2.3 years] |
Number of patients with ≥ 50% prostate-specific antigen (PSA) decrease from baseline | To assess the preliminary antitumour activity of AZD5305 in combination with NHA. | From Screening (Day -28) to confirmed disease progression [assessed up to 2.3 years] |
Number of patients with ≥ 90% prostate-specific antigen (PSA) decrease from baseline | To assess the preliminary antitumour activity of AZD5305 in combination with NHA. | From Screening (Day -28) to confirmed disease progression [assessed up to 2.3 years] |
Part B: Number of patients with undetectable PSA (< 0.2 ng/mL) | To assess the preliminary antitumour activity of AZD5305 in combination with NHA. | 3, 6, 9 and 12 months |
PSA Progression-free survival | To assess the preliminary antitumour activity of AZD5305 in combination with NHA. | 6, 12, 18, 24 and 30 months |
AUC of Enzalutamide | To characterize the PK (AUC) of Enzalutamide in plasma at steady state when given orally in combination with AZD5305 | 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) |
Cmax of Enzalutamide | To characterize the PK (Cmax) of Enzalutamide in plasma at steady state when given orally in combination with AZD5305 | 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) |
tmax of Enzalutamide | To characterize the PK (tmax) of Enzalutamide in plasma at steady state when given orally in combination with AZD5305 | 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) |
AUC of Apalutamide | To characterize the PK (AUC) of Apalutamide in plasma at steady state when given orally in combination with AZD5305 | 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) |
Cmax of Apalutamide | To characterize the PK (Cmax) of Apalutamide in plasma at steady state when given orally in combination with AZD5305 | 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) |
tmax of Apalutamide | To characterize the PK (tmax) of Apalutamide in plasma at steady state when given orally in combination with AZD5305 | 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) |
Part B: Homologous recombination repair gene mutation (HRRRm) | To investigate HRRm (including BRCA1/2) and their relationship with clinical response | From Screening (Day -28) to confirmed disease progression [assessed up to 2.3 years] |
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