AstraZeneca
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.
Metastatic Prostate Cancer
AZD5305
Enzalutamide
Abiraterone Acetate
Darolutamide
Phase 1
Phase 2
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 3 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 3 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 520 patients will be enrolled and screened to ensure the required number of evaluable patients in each part and arm are enrolled. For Part A, 300 patients may be screened to obtain up to approximately 252 patients that can be assigned to study treatments across all study arms (1 to 3). For Part B dose expansion cohorts, up to 220 patients may be screened to obtain up to approximately 180 patients that can be assigned to study treatments across all study arms (1 to 3). 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.
Study Type : | Interventional |
Estimated Enrollment : | 172 participants |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official 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) |
Actual Study Start Date : | June 2, 2022 |
Estimated Primary Completion Date : | August 15, 2030 |
Estimated Study Completion Date : | August 15, 2030 |
Arm | Intervention/treatment |
---|---|
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 Drug: Enzalutamide |
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 Drug: Abiraterone Acetate |
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 Drug: Darolutamide |
Ages Eligible for Study: | 18 Years to 130 Years |
Sexes Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
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San Diego, California, United States, 92123
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Indianapolis, Indiana, United States, 46202
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Detroit, Michigan, United States, 48201
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Detroit, Michigan, United States, 48202
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Syracuse, New York, United States, 13210
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Philadelphia, Pennsylvania, United States, 19111
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Myrtle Beach, South Carolina, United States, 29572
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Houston, Texas, United States, 77030
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Houston, Texas, United States, 77094
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Camperdown, Australia, 2050
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Darlinghurst, Australia, 2010
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East Melbourne, Australia, 3002
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Heidelberg, Australia, 3084
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Melbourne, Australia, 3004
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St. Leonards, Australia, 2065
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Candiolo, Italy, 10060
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Milano, Italy, 20133
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Milano, Italy, 20141
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Orbassano, Italy, 10043
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Padova, Italy, 35128
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Pavia, Italy, 27100
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Cambridge, United Kingdom, CB2 0QQ
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Glasgow, United Kingdom, G12 0YN
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Hampshire, United Kingdom, SO16 6YD
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Manchester, United Kingdom, M20 4BX
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Newcastle Upon Tyne, United Kingdom, NE7 7JA
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Plymouth, United Kingdom, PL6 8DH