Study of AZD0516 Alone and with Other Treatments for Metastatic Prostate Cancer
Sponsor: AstraZeneca
ClinicalTrials ID:NCT07181161
This clinical trial is testing the safety and tolerability of a new drug, AZD0516, both on its own and in combination with other cancer treatments, for men with metastatic prostate cancer.
Patient Parameters
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Program Overview
The study aims to find out if AZD0516, a new drug, is safe and well-tolerated when used alone or with other cancer treatments in men with metastatic prostate cancer. It will be conducted in multiple centers and will include different parts to evaluate the drug's safety, how the body processes it, and its effects on the immune system.
Description
This study is the first time AZD0516 is being tested in humans. It is a Phase I/IIa study, meaning it is in the early stages of testing. The study is open-label, so both the researchers and participants know what treatment is being given. It will take place in multiple locations and will have different parts to assess the drug's safety, how it is processed in the body, and its effects on the immune system.
Module 1 will test AZD0516 on its own. It may have three parts: Part A will find the right dose, Part B will optimize the dose, and Part C will see how effective it is.
Module 2 will test AZD0516 with another drug, AZD9574. It may have two parts: Part A will find the right dose, and Part B will optimize the dose.
Eligibility Criteria
Inclusion Criteria
- Confirmed diagnosis of metastatic prostate cancer.
- PSA level of at least 1 ng/mL.
- Undergoing treatment to lower testosterone levels, either through surgery or medication, with testosterone levels at or below 50 ng/dL.
- Good overall health with an ECOG performance status of 0 or 1.
- Adequate organ and bone marrow function without recent blood transfusions or growth factor support.
- Provide a tumor sample for analysis.
- Evidence of metastatic prostate cancer.
- Life expectancy of at least 12 weeks.
- Evidence of cancer progression, such as rising PSA levels, new bone lesions, or tumor growth on scans.
Exclusion Criteria
- Spinal cord compression or brain metastases unless treated and stable without needing high-dose steroids.
- History of cancer spreading to the brain or spinal fluid.
- Unresolved side effects from previous treatments, except for certain conditions like hair loss or controlled hormone disorders.
- Serious illnesses in the past year.
- Heart problems, such as arrhythmias or heart failure.
- History of other cancers.
- Lung diseases like interstitial lung disease or pneumonitis.
- Active infections, including tuberculosis, hepatitis B or C, or HIV.
- Bleeding disorders.
- Severe lung issues.
- Blood disorders like myelodysplastic syndrome or acute myeloid leukemia.
- Previous treatment with certain cancer drugs.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Research Site | 72703 | Fayetteville | Arkansas |
| Research Site | 90095 | Los Angeles | California |
| Research Site | 02114 | Boston | Massachusetts |
| Research Site | 48109 | Ann Arbor | Michigan |
| Research Site | 48201 | Detroit | Michigan |
| Research Site | 14263 | Buffalo | New York |
| Research Site | 10065 | New York | New York |
| Research Site | 02906 | Providence | Rhode Island |
| Research Site | 29572 | Myrtle Beach | South Carolina |
| Research Site | 77030 | Houston | Texas |
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