Study of AZD5305 When Given in Combination With New Hormonal Agents in Patients With Metastatic Prostate Cancer
PETRANHA
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)
3 other identifiers
interventional
174
4 countries
20
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Jun 2022
Longer than P75 for phase_1
20 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 19, 2022
CompletedFirst Posted
Study publicly available on registry
May 10, 2022
CompletedStudy Start
First participant enrolled
June 2, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 11, 2031
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 11, 2031
December 8, 2025
December 1, 2025
8.9 years
April 19, 2022
December 2, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (22)
Area Under the concentration Curve (AUC) of AZD5305
At the end of Cycle 0 (Cycle 0 is of 7 days)
Maximum plasma concentration (Cmax) of AZD5305
At the end of Cycle 0 (Cycle 0 is of 7 days)
Time to maximum concentration (tmax) of AZD5305
At the end of Cycle 0 (Cycle 0 is of 7 days)
AUC of AZD5305
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
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)
- +17 more secondary outcomes
Study Arms (4)
Arm 1 (AZD5305 in combination with enzalutamide)
EXPERIMENTALPatients 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.
Arm 2 (AZD5305 in combination with abiraterone acetate)
EXPERIMENTALPatients 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.
Arm 3 (AZD5305 in combination with darolutamide)
EXPERIMENTALPatients 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.
Arm 4 (AZD5305 in combination with apalutamide)
EXPERIMENTALPatients 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.
Interventions
Patients will receive an oral dose of AZD5305 once daily
Patients will receive an oral dose of Enzalutamide once daily
Patients will receive an oral dose of Abiraterone Acetate once daily
Patients will receive an oral dose of Darolutamide twice daily
Patients will receive an oral dose of Apalutamide once daily
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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:
- Strong and moderate CYP3A4 inducers/inhibitors (applies for all arms)
- For Arm 1 (enzalutamide) patients: Strong CYP2C8 inhibitors
- 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:
- 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.
- 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.
- 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.
- +19 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
- Bayercollaborator
Study Sites (20)
Research Site
Detroit, Michigan, 48201, United States
Research Site
Detroit, Michigan, 48202, United States
Research Site
Syracuse, New York, 13210, United States
Research Site
Myrtle Beach, South Carolina, 29572, United States
Research Site
Houston, Texas, 77030, United States
Research Site
Houston, Texas, 77094, United States
Research Site
Camperdown, 2050, Australia
Research Site
Darlinghurst, 2010, Australia
Research Site
East Melbourne, 3002, Australia
Research Site
Heidelberg, 3084, Australia
Research Site
Melbourne, 3004, Australia
Research Site
St Leonards, 2065, Australia
Research Site
Candiolo, 10060, Italy
Research Site
Milan, 20133, Italy
Research Site
Orbassano, 10043, Italy
Research Site
Padua, 35128, Italy
Research Site
Cambridge, CB2 0QQ, United Kingdom
Research Site
Glasgow, G12 0YN, United Kingdom
Research Site
Manchester, M20 4BX, United Kingdom
Research Site
Plymouth, PL6 8DH, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 19, 2022
First Posted
May 10, 2022
Study Start
June 2, 2022
Primary Completion (Estimated)
April 11, 2031
Study Completion (Estimated)
April 11, 2031
Last Updated
December 8, 2025
Record last verified: 2025-12
Data Sharing
- IPD Sharing
- Will share
- Time Frame
- AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
- Access Criteria
- When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool. Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
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.