Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Antineoplastic Agents

All Drugs and Chemicals

Abiraterone Acetate

Enzyme Inhibitors

Hormones

Hormone Antagonists

Cytochrome P-450 Enzyme Inhibitors

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.

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.

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.

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.

Patients will receive an oral dose of AZD5305 once daily

AZD5305

Patients will receive an oral dose of Enzalutamide once daily

Enzalutamide

Patients will receive an oral dose of Abiraterone Acetate once daily

Patients will receive an oral dose of Darolutamide twice daily

Darolutamide

Patients will receive an oral dose of Apalutamide once daily

Apalutamide

AstraZeneca Clinical Study Information Center

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.

Study of AZD5305 When Given in Combination With New Hormonal Agents in Patients With Metastatic Prostate Cancer

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)

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

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.

To assess the safety and tolerability of AZD5305 when given in combination with NHA.

To characterise the PK (AUC) of AZD5305 at steady state after multiple dosing of AZD5305 monotherapy.

To characterise the PK (Cmax) of AZD5305 at steady state after multiple dosing of AZD5305 monotherapy.

To characterise the PK (tmax) of AZD5305 at steady state after multiple dosing of AZD5305 monotherapy.

To characterise the PK (AUC) of AZD5305 following oral dose administration of AZD5305 in combination with NHA.

To characterise the PK (Cmax) of AZD5305 following oral dose administration of AZD5305 in combination with NHA.

To characterise the PK (tmax) of AZD5305 following oral dose administration of AZD5305 in combination with NHA.

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.

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).

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.

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.

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.

To assess the preliminary antitumour activity of AZD5305 in combination with NHA.

To characterize the PK (AUC) of Enzalutamide in plasma at steady state when given orally in combination with AZD5305

To characterize the PK (Cmax) of Enzalutamide in plasma at steady state when given orally in combination with AZD5305

To characterize the PK (tmax) of Enzalutamide in plasma at steady state when given orally in combination with AZD5305

To characterize the PK (AUC) of Apalutamide in plasma at steady state when given orally in combination with AZD5305

To characterize the PK (Cmax) of Apalutamide in plasma at steady state when given orally in combination with AZD5305

To characterize the PK (tmax) of Apalutamide in plasma at steady state when given orally in combination with AZD5305

To investigate HRRm (including BRCA1/2) and their relationship with clinical response

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Study of AZD5305 When Given in Combination With New Hormonal Agents in Patients With Metastatic Prostate Cancer	NCT05367440	Metastatic Pros...	AZD5305 Enzalutamide Abiraterone Ace... Darolutamide Apalutamide	18 Years - 130 Years	AstraZeneca
Study of AZD5305 When Given in Combination With New Hormonal Agents in Patients With Metastatic Prostate Cancer	NCT05367440	Metastatic Pros...	AZD5305 Enzalutamide Abiraterone Ace... Darolutamide Apalutamide	18 Years - 130 Years	AstraZeneca

Spots Global Cancer Trial Database for new hormonal agents