Study of AZD5305 Combined with New Hormonal Agents for Metastatic Prostate Cancer

Sponsor: AstraZeneca

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT05367440

Provider View

This clinical trial is testing the safety and effectiveness of a new drug, AZD5305, when used with other hormonal treatments in patients with metastatic prostate cancer.

Patient Parameters

Program Overview

The study aims to evaluate how safe and effective AZD5305 is when combined with new hormonal treatments for patients with metastatic prostate cancer. It will look at how the body processes the drug and its effects on the cancer.

Description

The study is divided into two parts: Part A and Part B.

  • Part A: This part will test different doses of AZD5305 combined with new hormonal agents in patients with metastatic castration-resistant prostate cancer (mCRPC) or metastatic castration-sensitive prostate cancer (mCSPC). It will focus on safety and how well the treatment works.

  • Part B: This part will expand on the findings from Part A and will only include patients with mCSPC. It will further explore the effectiveness and safety of the treatment.

The study plans to enroll about 783 patients to ensure enough participants for each part. Treatment will continue until the cancer progresses, the patient starts a new cancer treatment, experiences unacceptable side effects, withdraws consent, or for other reasons.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Have a confirmed diagnosis of metastatic prostate cancer.
  • Eligible for treatment with specific hormonal drugs like enzalutamide or abiraterone.
  • Must have undergone surgical or medical castration.
  • Have good organ and bone marrow function.
  • Have a performance status score of 0 or 1, indicating good overall health.
  • Life expectancy of at least 16 weeks.
  • Men must use a condom with spermicide during and for 6 months after treatment if sexually active with a woman who can become pregnant.

For Part A:

  • Patients with mCRPC or mCSPC.

For Part B:

  • Patients with mCSPC and a specific PSA level.

Exclusion Criteria

For Part A mCRPC patients only:

  • Previous treatment with certain hormonal agents, PARP inhibitors, or specific cancer therapies.

For Part A and Part B mCSPC Patients:

  • Previous treatment with certain cancer drugs or therapies.
  • Use of certain medications or supplements that affect drug metabolism.
  • Recent treatment with investigational drugs or vaccines.
  • Major surgery or radiation therapy recently.
  • Unresolved side effects from previous treatments.
  • Severe blood disorders or untreated brain or spinal cord issues.
  • Severe or uncontrolled diseases or infections.
  • History of certain heart or blood conditions.
  • Allergies to study drugs or their components.
  • Conditions that could interfere with the study.
  • Recent participation in another clinical trial.
  • Specific conditions related to the hormonal drugs being tested.

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