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

Part of paid clinical trials in Detroit, Michigan.

Sponsor
AstraZeneca
Study ID
NCT05367440
Phase
PHASE1/PHASE2
Status
Active Not Recruiting

Conditions

  • Metastatic Prostate Cancer

Eligibility Criteria

Sex
MALE
Age
18 Years - 130 Years
Healthy Volunteers
Not accepted

Interventions

  • AZD5305 — DRUG
    Patients will receive an oral dose of AZD5305 once daily
  • Enzalutamide — DRUG
    Patients will receive an oral dose of Enzalutamide once daily
  • Abiraterone Acetate — DRUG
    Patients will receive an oral dose of Abiraterone Acetate once daily
  • Darolutamide — DRUG
    Patients will receive an oral dose of Darolutamide twice daily
  • Apalutamide — DRUG
    Patients will receive an oral dose of Apalutamide once daily

Study Details

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.

Key Dates

Start date
Jun 2, 2022
Status verified
May 2026
Primary completion
Apr 11, 2031
Completion
Apr 11, 2031

Study Design

Enrollment
174 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.
  • 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.
  • 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.
  • 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.

Primary Outcome Measure

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] ]

Locations (6)

FacilityCityStateZIPSite coordinators
Research SiteDetroitMichigan48201-
Research SiteDetroitMichigan48202-
Research SiteSyracuseNew York13210-
Research SiteMyrtle BeachSouth Carolina29572-
Research SiteHoustonTexas77030-
Research SiteHoustonTexas77094-

Find similar trials in Detroit, MI

By research site
Research Site· Detroit, MIResearch Site· Syracuse, NYResearch Site· Myrtle Beach, SCResearch Site· Houston, TX

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