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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05367440
Recruitment Status : Recruiting
First Posted : May 10, 2022
Last Update Posted : April 25, 2024
Sponsor:
Collaborator:
Bayer
Information provided by (Responsible Party):
AstraZeneca

Study Description
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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.

Condition or disease Intervention/treatment Phase
Metastatic Prostate Cancer Drug: AZD5305 Drug: Enzalutamide Drug: Abiraterone Acetate Drug: Darolutamide Drug: Apalutamide Phase 1 Phase 2

Detailed Description:

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 172 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arms and Interventions
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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
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


Outcome Measures
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Primary Outcome Measures :
  1. Number of patients with Adverse Events and Serious Adverse Events [ Time Frame: Up to post treatment follow-up (28 days after last dose) [assessed up to 2.3 years] ]
    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.

  2. Part A: Number of patients with Dose Limiting Toxicities (DLTs) [ Time Frame: For Arm 1: 35 days, For Arm 2 and 3: 28 days ]
    To assess the safety and tolerability of AZD5305 when given in combination with NHA.


Secondary Outcome Measures :
  1. Area Under the concentration Curve (AUC) of AZD5305 [ Time Frame: At the end of Cycle 0 (Cycle 0 is of 7 days) ]
    To characterise the PK (AUC) of AZD5305 at steady state after multiple dosing of AZD5305 monotherapy.

  2. Maximum plasma concentration (Cmax) of AZD5305 [ Time Frame: At the end of Cycle 0 (Cycle 0 is of 7 days) ]
    To characterise the PK (Cmax) of AZD5305 at steady state after multiple dosing of AZD5305 monotherapy.

  3. Time to maximum concentration (tmax) of AZD5305 [ Time Frame: At the end of Cycle 0 (Cycle 0 is of 7 days) ]
    To characterise the PK (tmax) of AZD5305 at steady state after multiple dosing of AZD5305 monotherapy.

  4. AUC of AZD5305 [ Time Frame: 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) ]
    To characterise the PK (AUC) of AZD5305 following oral dose administration of AZD5305 in combination with NHA.

  5. Cmax of AZD5305 [ Time Frame: 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) ]
    To characterise the PK (Cmax) of AZD5305 following oral dose administration of AZD5305 in combination with NHA.

  6. tmax of AZD5305 [ Time Frame: 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) ]
    To characterise the PK (tmax) of AZD5305 following oral dose administration of AZD5305 in combination with NHA.

  7. Objective response rate (ORR) [ Time Frame: From Screening (Day -28) to confirmed disease progression [assessed up to 2.3 years] ]
    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.

  8. Duration of response (DoR) [ Time Frame: From Screening (Day -28) to confirmed disease progression [assessed up to 2.3 years] ]
    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).

  9. Time to response (TTR) [ Time Frame: From Screening (Day -28) to confirmed disease progression [assessed up to 2.3 years] ]
    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.

  10. Radiographic progression-free survival (rPFS) [ Time Frame: From Screening (Day -28), 12 months, 24 months and up to confirmed disease progression [assessed up to 2.3 years] ]
    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.

  11. Percentage change in tumour size [ Time Frame: From Screening (Day -28) to confirmed disease progression [assessed up to 2.3 years] ]
    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.

  12. Number of patients with ≥ 50% prostate-specific antigen (PSA) decrease from baseline [ Time Frame: From Screening (Day -28) to confirmed disease progression [assessed up to 2.3 years] ]
    To assess the preliminary antitumour activity of AZD5305 in combination with NHA.

  13. Number of patients with ≥ 90% prostate-specific antigen (PSA) decrease from baseline [ Time Frame: From Screening (Day -28) to confirmed disease progression [assessed up to 2.3 years] ]
    To assess the preliminary antitumour activity of AZD5305 in combination with NHA.

  14. Part B: Number of patients with undetectable PSA (< 0.2 ng/mL) [ Time Frame: 3, 6, 9 and 12 months ]
    To assess the preliminary antitumour activity of AZD5305 in combination with NHA.

  15. PSA Progression-free survival [ Time Frame: 6, 12, 18, 24 and 30 months ]
    To assess the preliminary antitumour activity of AZD5305 in combination with NHA.

  16. AUC of Enzalutamide [ Time Frame: 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) ]
    To characterize the PK (AUC) of Enzalutamide in plasma at steady state when given orally in combination with AZD5305

  17. Cmax of Enzalutamide [ Time Frame: 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) ]
    To characterize the PK (Cmax) of Enzalutamide in plasma at steady state when given orally in combination with AZD5305

  18. tmax of Enzalutamide [ Time Frame: 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) ]
    To characterize the PK (tmax) of Enzalutamide in plasma at steady state when given orally in combination with AZD5305

  19. AUC of Apalutamide [ Time Frame: 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) ]
    To characterize the PK (AUC) of Apalutamide in plasma at steady state when given orally in combination with AZD5305

  20. Cmax of Apalutamide [ Time Frame: 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) ]
    To characterize the PK (Cmax) of Apalutamide in plasma at steady state when given orally in combination with AZD5305

  21. tmax of Apalutamide [ Time Frame: 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) ]
    To characterize the PK (tmax) of Apalutamide in plasma at steady state when given orally in combination with AZD5305

  22. Part B: Homologous recombination repair gene mutation (HRRRm) [ Time Frame: From Screening (Day -28) to confirmed disease progression [assessed up to 2.3 years] ]
    To investigate HRRm (including BRCA1/2) and their relationship with clinical response


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 130 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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:

    1. Strong and moderate CYP3A4 inducers/inhibitors (applies for all arms)
    2. For Arm 1 (enzalutamide) patients: Strong CYP2C8 inhibitors
    3. 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:

    1. 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.
    2. 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.
    3. 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.
  • Major surgery within 4 weeks prior to the first dose of study treatment.
  • Radiotherapy with a wide field of radiation within 4 weeks or radiotherapy with a limited field of radiation for palliation within 2 weeks of the first dose of study treatment.
  • With the exception of alopecia, and peripheral neuropathy; any unresolved toxicities from prior therapy greater than Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 at the time of study enrolment.
  • Any history of persisting (> 2 weeks) severe pancytopenia.
  • Spinal cord compression, or brain metastases unless asymptomatic and treated and stable.
  • Any evidence of severe or uncontrolled systemic diseases, including, active bleeding diatheses, or active infection including hepatitis B, hepatitis C and human immunodeficiency virus (HIV).
  • Patients with any known predisposition to bleeding (eg, active peptic ulceration, recent [within 6 months] haemorrhagic stroke, proliferative diabetic retinopathy.
  • Any clinically significant cardiac disorders including QT prolongation, abnormal electrocardiogram (ECG).
  • Any clinically significant cardiovascular diseases including symptomatic heart failure, uncontrolled hypertension, acute coronary syndrome, cardiomyopathy, valvular heart disease, atrial fibrillation, stroke.
  • Patients with history of myelodysplastic syndrome (MDS)/ acute myeloid leukaemia (AML).
  • Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the formulated product or previous significant bowel resection.
  • Known allergy or hypersensitivity to investigational product(s) or any of the excipients of the investigational product(s).
  • Any condition that would interfere with evaluation of the study treatment or interpretation of patient safety or study results.
  • Uncontrolled intercurrent illness within the last 12 months, including but not limited to, active interstitial lung disease, serious chronic gastrointestinal (GI) conditions associated with diarrhoea, or psychiatric illness/social situations
  • History of another primary malignancy except for malignancy treated with curative intent with no known active disease within 3 years before the first dose of study treatment and of low potential risk for recurrence.
  • Concurrent enrolment in another clinical study, unless it is an observational (non-interventional) clinical study or during the follow-up period of an interventional study.
  • Arm 1 (Enzalutamide) and Arm 4 (Apalutamide): History of seizure or any condition that may predispose to seizure (eg, prior cortical stroke, significant brain trauma).
  • Arm 2 (Abiraterone acetate) only: (i) Active infection or other medical condition that would contraindicate the use of systemic steroids (prednisone/prednisolone). (ii) Low serum potassium (< 3.5 mmol/L). (iii) History of uncontrolled pituitary or adrenal dysfunction.
  • Arm 4 (Apalutamide): (i) Moderate or severe skin conditions or diseases that could affect the skin (eg. scleroderma, lupus). (ii) Any skin or medical condition that in the Investigator's opinion could increase the risk of skin toxicity.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05367440


Contacts
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Contact: AstraZeneca Clinical Study Information Center 1-877-240-9479 information.center@astrazeneca.com

Locations
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United States, California
Research Site Withdrawn
San Diego, California, United States, 92123
United States, Indiana
Research Site Recruiting
Indianapolis, Indiana, United States, 46202
United States, Michigan
Research Site Recruiting
Detroit, Michigan, United States, 48201
Research Site Recruiting
Detroit, Michigan, United States, 48202
United States, New York
Research Site Recruiting
Syracuse, New York, United States, 13210
United States, Pennsylvania
Research Site Withdrawn
Philadelphia, Pennsylvania, United States, 19111
United States, South Carolina
Research Site Recruiting
Myrtle Beach, South Carolina, United States, 29572
United States, Texas
Research Site Recruiting
Houston, Texas, United States, 77030
Research Site Recruiting
Houston, Texas, United States, 77094
Australia
Research Site Recruiting
Camperdown, Australia, 2050
Research Site Recruiting
Darlinghurst, Australia, 2010
Research Site Recruiting
East Melbourne, Australia, 3002
Research Site Recruiting
Heidelberg, Australia, 3084
Research Site Recruiting
Melbourne, Australia, 3004
Research Site Recruiting
St. Leonards, Australia, 2065
Italy
Research Site Recruiting
Candiolo, Italy, 10060
Research Site Recruiting
Milano, Italy, 20133
Research Site Recruiting
Milano, Italy, 20141
Research Site Recruiting
Orbassano, Italy, 10043
Research Site Recruiting
Padova, Italy, 35128
Research Site Recruiting
Pavia, Italy, 27100
United Kingdom
Research Site Recruiting
Cambridge, United Kingdom, CB2 0QQ
Research Site Recruiting
Glasgow, United Kingdom, G12 0YN
Research Site Withdrawn
Hampshire, United Kingdom, SO16 6YD
Research Site Recruiting
Manchester, United Kingdom, M20 4BX
Research Site Withdrawn
Newcastle Upon Tyne, United Kingdom, NE7 7JA
Research Site Recruiting
Plymouth, United Kingdom, PL6 8DH
Sponsors and Collaborators
AstraZeneca
Bayer
More Information
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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT05367440    
Other Study ID Numbers: D9720C00003
2021-006289-19 ( EudraCT Number )
First Posted: May 10, 2022    Key Record Dates
Last Update Posted: April 25, 2024
Last Verified: April 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

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.
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.
URL: https://astrazenecagroup-dt.pharmacm.com/DT/Home

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by AstraZeneca:
PETRANHA
AZD5305
New Hormonal Agents
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Genital Diseases
Urogenital Diseases
Prostatic Diseases
Male Urogenital Diseases
 Abiraterone Acetate
Antineoplastic Agents
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 Enzyme Inhibitors