Study identifier:D9720C00003
ClinicalTrials.gov identifier:NCT05367440
EudraCT identifier:2021-006289-19
CTIS identifier:2023-508536-64-00
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)
Metastatic Prostate Cancer
Phase 1/2
No
AZD5305, Enzalutamide, Abiraterone Acetate, Darolutamide, Apalutamide
Male
190
Interventional
18 Years - 130 Years
Allocation: Non-randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Verified 01 May 2025 by AstraZeneca
AstraZeneca
Bayer
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.
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.
Location
Status
Location
Cambridge, United Kingdom, CB2 0QQ
Status
Recruiting
Location
Hampshire, United Kingdom, SO16 6YD
Status
Withdrawn
Location
Plymouth, United Kingdom, PL6 8DH
Status
Recruiting
Location
Newcastle Upon Tyne, United Kingdom, NE7 7JA
Status
Withdrawn
Location
Glasgow, United Kingdom, G12 0YN
Status
Recruiting
Location
Orbassano, Italy, 10043
Status
Recruiting
Location
Candiolo, Italy, 10060
Status
Recruiting
Location
Milano, Italy, 20133
Status
Recruiting
Arms | Assigned Interventions |
---|---|
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. | Drug: AZD5305 Patients will receive an oral dose of AZD5305 once daily Drug: Enzalutamide Patients will receive an oral dose of Enzalutamide once daily Other Name: Xtandi |
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. | Drug: AZD5305 Patients will receive an oral dose of AZD5305 once daily Drug: Abiraterone Acetate Patients will receive an oral dose of Abiraterone Acetate once daily Other Name: Zytiga |
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. | Drug: AZD5305 Patients will receive an oral dose of AZD5305 once daily Drug: Darolutamide Patients will receive an oral dose of Darolutamide twice daily Other Name: Nubeqa |
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. | Drug: Apalutamide Patients will receive an oral dose of Apalutamide once daily Other Name: Erleada |
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